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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003019-21 | EudraCT Number |
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The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan | Experimental | Participants will receive sacituzumab govitecan on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs). |
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| Treatment of Physician's Choice (TPC) | Active Comparator | Participants will receive TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab govitecan | Drug | 10 mg/kg administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump. Infusion rate for the first 15 minutes will start with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population | PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. | From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by IRC Assessment in the ITT Population | PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center, 29653 Anchor Cross Blvd | Daphne | Alabama | 36526 | United States | ||
| Souther Cancer Center, 3719 Dauphin St., 5 Floor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30786188 | Background | Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213. | |
| Result | Huvitz SA, Tolaney SM, Punie K, et al. 2020 SABCS GS3-06. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX. | ||
| Result | Dieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
18 months after study completion
A secured external environment with username, password, and RSA code.
730 participants were screened.
Participants were enrolled at study sites in Belgium, Canada, France, Germany, Spain, the United Kingdom, and the United States. The first participant was screened on 07 November 2017. The last study visit occurred on 08 December 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sacituzumab Govitecan | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2019 | Feb 25, 2021 |
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| Eribulin | Drug | Administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses will be administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). |
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| Capecitabine | Drug | 1000 to 1250 mg/m^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. |
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| Gemcitabine | Drug | 800 to 1200 mg/m^2 will be administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. |
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| Vinorelbine | Drug | 25 mg/m^2 will be administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine will not be allowed as TPC for any participant with Grade 2 neuropathy. |
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| From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Overall Survival (OS) in BM-ve Population | Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) |
| Overall Survival (OS) in ITT Population | Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) |
| Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population | ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions. | From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Time to Objective Response by the Investigator Assessment in BM-ve Population | Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Time to Objective Response by the IRC Assessment in BM-ve Population | Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population | DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. | From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Time to Progression (TTP) by Investigator Assessment in BM-ve Population | Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Time to Progression (TTP) by IRC Assessment in BM-ve Population | Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population | CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug | Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:
| First dose date up to last follow-up (maximum up to 30.8 months) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score | The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement. | Baseline; End of Treatment (EOT) (up to 29.6 months) |
| Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline | Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. | First dose date up to last follow-up (maximum up to 30.8 months) |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Southern Cancer Center, 3 Mobile Infirmary Circle | Mobile | Alabama | 36608 | United States |
| Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level | Mobile | Alabama | 36608 | United States |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States |
| Mayo Clinic Hospital | Scottsdale | Arizona | 85259 | United States |
| UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200 | Alhambra | California | 91801 | United States |
| UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200 | Burbank | California | 91505 | United States |
| UCLA Jonsson Comprehensive Cancer Center | Laguna Hills | California | 92653 | United States |
| UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza | Los Angeles | California | 90095 | United States |
| UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320 | Pasadena | California | 91105 | United States |
| University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street | San Francisco | California | 94115 | United States |
| UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard | Santa Monica | California | 94115 | United States |
| Rocky Mountain Cancer Centers, 1700 South Potomac Street | Aurora | Colorado | 80012-5405 | United States |
| University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Centers, 4715 Arapahoe Ave | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400 | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer Centers, 1800 Williams St. | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400 | Denver | Colorado | 80220 | United States |
| Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450 | Englewood | Colorado | 80113 | United States |
| Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100 | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers, 22 West Dry Creek Circle | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01 | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210 | Longmont | Colorado | 80501 | United States |
| Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421 | Parker | Colorado | 80138 | United States |
| Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350 | Pueblo | Colorado | 81008 | United States |
| Rocky Mountain Cancer Centers, 8820 Huron Street | Thornton | Colorado | 80260 | United States |
| Yale School Of Medicine | New Haven | Connecticut | 06510-3206 | United States |
| Norwalk Hospital, 34 Maple Street | Norwalk | Connecticut | 06856 | United States |
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive | Altamonte Springs | Florida | 32701 | United States |
| Florida Cancer Specialist | Bonita Springs | Florida | 34135 | United States |
| Florida Cancer Specialists | Bradenton | Florida | 34209 | United States |
| Florida Cancer Specialists & Research Institute, 403 S. King Ave | Brandon | Florida | 33511 | United States |
| Florida Cancer Specialists | Cape Coral | Florida | 33914 | United States |
| Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road | Clearwater | Florida | 33761 | United States |
| Sylvester Comprehensive Cancer Center | Coral Gables | Florida | 33146 | United States |
| Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway | Daytona Beach | Florida | 32117 | United States |
| Sylvester Comprehensive Cancer Center | Deerfield Beach | Florida | 33442 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33905 | United States |
| Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing | Gainesville | Florida | 32605 | United States |
| Florida Cancer Specialists & Research Institute, 100 Highland Avenue | Largo | Florida | 33770 | United States |
| Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway | Lecanto | Florida | 34461 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Baptist Health Medical Group Oncology, LLC | Miami | Florida | 33176 | United States |
| Florida Cancer Specialists | Naples | Florida | 34102 | United States |
| Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd | New Port Richey | Florida | 34655 | United States |
| Florida Cancer Specialists & Research Institute, 1630 SE 18th ST | Ocala | Florida | 34471 | United States |
| Florida Cancer Specialists & Research Institute, 765 Image Way | Orange City | Florida | 32763 | United States |
| Orlando Regional Medical Center | Orlando | Florida | 32806-2008 | United States |
| Florida Cancer Specialists & Research Institute, 70 W Gore Street | Orlando | Florida | 32806 | United States |
| Florida Cancer Specialists & Research Institute - 325 Clyde Morris | Ormond Beach | Florida | 32774 | United States |
| Sylvester Comprehensive Cancer Center | Plantation | Florida | 33324 | United States |
| Florida Cancer Specialists | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34236 | United States |
| Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive | Spring Hill | Florida | 34608 | United States |
| Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North | St. Petersburg | Florida | 33705-1449 | United States |
| Florida Cancer Specialists & Research Institute, 560 Jackson St | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard | Tampa | Florida | 33607 | United States |
| Florida Cancer Specialists & Research Institute, 4100 Waterman Way | Tavares | Florida | 32778 | United States |
| Florida Cancer Specialists & Research Institute, 1400 US highway 441 N | The Villages | Florida | 32159 | United States |
| Florida Cancer Specialists | Venice | Florida | 34285 | United States |
| Florida Cancer Specialists | Venice | Florida | 34292 | United States |
| Florida Cancer Specialists & Research Institute - 3730 7th Terrace | Vero Beach | Florida | 32960 | United States |
| Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B | Wellington | Florida | 98374 | United States |
| Florida Cancer Specialists & Research Institute1309 N Flagler Dr | West Palm Beach | Florida | 33401-3406 | United States |
| Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive | Winter Park | Florida | 32792 | United States |
| Atlanta Cancer Center - Alpharetta | Alpharetta | Georgia | 30005 | United States |
| University Cancer & Blood Center, 3320 Old Jefferson Rd | Athens | Georgia | 30607 | United States |
| GCS/Annex | Atlanta | Georgia | 30341 | United States |
| Atlanta Cancer Care - Atlanta | Atlanta | Georgia | 30342 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| GCS/Canton | Canton | Georgia | 30114 | United States |
| Atlanta Cancer Care - Conyers | Conyers | Georgia | 30094 | United States |
| Atlanta Cancer Care - Cumming | Cumming | Georgia | 30041 | United States |
| Atlanta Cancer Care - Decatur | Decatur | Georgia | 30033 | United States |
| GCS/Stemmer | Decatur | Georgia | 30033 | United States |
| Atlanta Cancer Care - Stockbridge | Jonesboro | Georgia | 30236 | United States |
| GCS/Macon | Macon | Georgia | 31217 | United States |
| GCS/Kennestone | Marietta | Georgia | 30060 | United States |
| GCS/Northside | Sandy Springs | Georgia | 30342 | United States |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | United States |
| University of Chicago Medical Center 5841 S. Maryland Ave | Chicago | Illinois | 60637 | United States |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd | New Lenox | Illinois | 60451 | United States |
| Illinois Cancer Specialists | Niles | Illinois | 60714-5905 | United States |
| Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd | Orland Park | Illinois | 60462 | United States |
| MidAmerica Division Inc. c/o Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion | Westwood | Kansas | 66205-2005 | United States |
| Maryland Oncology Hematology | Bethesda | Maryland | 20817 | United States |
| Maryland Oncology Hematology | Brandywine | Maryland | 20613 | United States |
| Maryland Oncology Hematology | Clinton | Maryland | 20735 | United States |
| Maryland Oncology Hematology | Columbia | Maryland | 21044 | United States |
| Maryland Oncology Hematology | Rockville | Maryland | 20850 | United States |
| Maryland Oncology Hematology | Silver Spring | Maryland | 20902 | United States |
| Maryland Oncology Hematology | Silver Spring | Maryland | 20904 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02114-2621 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215-5400 | United States |
| Mass General - North Shore Cancer Center ( NSCC ) | Danvers | Massachusetts | 01923 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Minnesota Oncology Hematology P.A. | Coon Rapids | Minnesota | 55433 | United States |
| Suburban Imaging Northwest | Coon Rapids | Minnesota | 55433 | United States |
| Suburban Imaging | Coon Rapids | Minnesota | 55433 | United States |
| Mercy Hospital - Unity Campus AHL | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology P.A. | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology P.A. | Minneapolis | Minnesota | 55404 | United States |
| Abbot Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Virginia G. Piper Cancer Center at HonorHealth | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic - 200 First Street SW | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine in St. Louis | Creve Coeur | Missouri | 63141 | United States |
| MidAmerica Division Inc. c/o Menorah Medical Center | Independence | Missouri | 64057 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63129 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63136 | United States |
| Nebraska Cancer Specialists - Midwest Cancer Center - Papillion | Omaha | Nebraska | 68114 | United States |
| Nebraska Cancer Specialists - Midwest Cancer Center - Paillion | Omaha | Nebraska | 68130 | United States |
| Nebraska Cancer Specialists- Midwest Cancer Center- Papillion | Papillion | Nebraska | 68046-5706 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| New York Oncology Hematology, P.C. | Clifton Park | New York | 12065 | United States |
| North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road | East Setauket | New York | 11733 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16 | Patchogue | New York | 11772 | United States |
| UNC Health Care System | Chapel Hill | North Carolina | 27599 | United States |
| The Ohio State University Wexner Medical Center, 460 W 10th Ave | Columbus | Ohio | 432100 | United States |
| The Ohio State University Wexner Medical Center, 1145 Olentangy River Road | Columbus | Ohio | 43212 | United States |
| Providence Medical Group | Portland | Oregon | 97213 | United States |
| UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion | Greensburg | Pennsylvania | 15601 | United States |
| UPMC Hillman Cancer Center UPMC East | Monroeville | Pennsylvania | 15146 | United States |
| UPMC Hillman Cancer Center Upper Saint Clair | Pittsburgh | Pennsylvania | 15102 | United States |
| Allegheny-Singer Research Institute, 320 East North Avenue | Pittsburgh | Pennsylvania | 15212 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Hillman Cancer Center UPMC Passavant | Pittsburgh | Pennsylvania | 15237 | United States |
| Tennessee Oncology - Chattanooga Oncology & Hematology Associates | Chattanooga | Tennessee | 37404-1108 | United States |
| Tennesee Oncology - PLLC | Chattanooga | Tennessee | 37404 | United States |
| Tenesse Oncology - PLLC | Cleveland | Tennessee | 37311 | United States |
| Tennessee Oncology, LLC | Dickson | Tennessee | 37055 | United States |
| Tennessee Ocology, LLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology, LLC | Gallatin | Tennessee | 37066 | United States |
| West Cancer Center, 7945 Wolf River Blvd | Germantown | Tennessee | 28138 | United States |
| Tennessee Oncology, LLC | Hermitage | Tennessee | 37076 | United States |
| Tennessee Oncology, LLC | Lebanon | Tennessee | 37090 | United States |
| Tennessee Oncology, LLC | Murfreesboro | Tennessee | 37129 | United States |
| Sarah Cannon Cancer Institute/Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology, LLC | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000 | Nashville | Tennessee | 37204 | United States |
| Tennessee Ocology, LLC | Nashville | Tennessee | 37205 | United States |
| Tennessee Oncology, LLC | Nashville | Tennessee | 37207 | United States |
| Tenessee Oncology | Nashville | Tennessee | 37211 | United States |
| Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232 | Nashville | Tennessee | 37232 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Tennessee Oncology, LLC | Shelbyville | Tennessee | 37160 | United States |
| Center for Cancer and Blood Disorders | Arlington | Texas | 76014 | United States |
| Center for Cancer and Blood Disorders | Burleson | Texas | 76028 | United States |
| Texas Oncology- Medical City Dallas Building D | Dallas | Texas | 75230-6899 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246-2006 | United States |
| Texas Oncology | Denton | Texas | 76210 | United States |
| Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104-4611 | United States |
| Houston Methodist Hospital - 6565 Fannin St | Houston | Texas | 77030 | United States |
| Texas Oncology-Longview Cancer Center | Longview | Texas | 75601 | United States |
| Texas Oncology | Plano | Texas | 75075-7753 | United States |
| US Oncology | Tyler | Texas | 75702 | United States |
| Center for Cancer and Blood Disorders | Weatherford | Texas | 76086 | United States |
| Virginia Cancer Specialists, PC | Alexandria | Virginia | 22304 | United States |
| Virginia Cancer Specialists, PC | Arlington | Virginia | 22205 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Blacksburg | Virginia | 24060 | United States |
| Virginia Oncology Associates | Chesapeake | Virginia | 23320 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031-4629 | United States |
| Virginia Cancer Specialists, PC | Gainesville | Virginia | 20155 | United States |
| Virginia Oncology Associates | Hampton | Virginia | 23666 | United States |
| Virginia Cancer Specialists, PC | Leesburg | Virginia | 20176 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Low Moor | Virginia | 24457 | United States |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | United States |
| Virginia Oncology Associates, P.C. | Norfolk | Virginia | 23502-0026 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Salem | Virginia | 24153 | United States |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | United States |
| Virginia Cancer Specialists, PC | Woodbridge | Virginia | 22191 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Wytheville | Virginia | 24382 | United States |
| Swedish Cancer Institute | Edmonds | Washington | 98026 | United States |
| Swedish Cancer Institute | Issaquah | Washington | 98029 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98122 | United States |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Universitair Zlekenhuis Brussel | Brussels | 1090 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Clinique et Maternite Sainte-Elisabeth | Namur | 5000 | Belgium |
| Cross Cancer Institute, 11560 University Avenue | Edmonton | Alberta | TG6 1Z2 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Jewish General Hospital, 3755 Côte-Sainte-Catherine | Montreal | Quebec | H3T 1E2 | Canada |
| Jewish General Hospital, 3755 Côte-Sainte-Catherine | Québec | Quebec | H3T 1E2 | Canada |
| Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin | Angers | 49005 | France |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | 25000 | France |
| Institut Régional du Cancer de Montpellier | Montpellier | France |
| Institut Curie | Paris | 75248 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Florence Lerebours | Saint-Cloud | 92210 | France |
| CHU de Nantes - Hôpital Nord Laennec | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94800 | France |
| Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus | Frankfurt | 60389 | Germany |
| Praxis für interdisziplinäre Onkologie & Hämatologie GbR | Freiburg im Breisgau | 79110 | Germany |
| Facharztzentrum Eppendorf | Hamburg | 20249 | Germany |
| Institut für Versorgungsforschung in der Onkologie | Koblenz | 56068 | Germany |
| Praxis für Hämatologie und Internistische Onkologie | Velbert | 42551 | Germany |
| Hospital Teresa Herrera, As Xubias, 84 | A Coruña | 15006 | Spain |
| Hospital Quirón Barcelona, Plaza Alfonso Comín 5 | Barcelona | 08023 | Spain |
| Hospital del Mar | Barcelona | 8003 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90 | Barcelona | 8041 | Spain |
| Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203 | L'Hospitalet de Llobregat | 08908 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | 25195 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road | Colchester | ESS | C04 5JL | United Kingdom |
| The Arden Cancer Centre- University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham | Durham | DH1 5TW | United Kingdom |
| The Royal Surrey County Hospital NHS Foundation Trust | Guildford | GU2 7XX | United Kingdom |
| The County Hospital, Wye Valley NHS Trust | Hereford | HR1 2BN | United Kingdom |
| The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology | London | NW3 2QG | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Nottingham University Hospitals NHS Trust - City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Plymouth Hospitals NHS Trust - Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital | Wakefield | WF1 4DG | United Kingdom |
| Result | Rugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX. |
| Result | Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325 |
| Result | Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05 |
| 39324726 | Derived | Loibl S, Loirat D, Tolaney SM, Punie K, Dieras V, Carey LA, Gianni L, Shah A, Phan S, Shi L, Spears PA, Piccart MJ. Summary of quality of life in the ASCENT phase 3 clinical trial for people with metastatic triple-negative breast cancer. Future Oncol. 2024;20(34):2609-2616. doi: 10.1080/14796694.2024.2381408. Epub 2024 Sep 26. |
| 38664404 | Derived | Hurvitz SA, Bardia A, Punie K, Kalinsky K, Carey LA, Rugo HS, Dieras V, Phan S, Delaney R, Zhu Y, Tolaney SM. Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2024 Apr 25;10(1):33. doi: 10.1038/s41523-024-00635-5. |
| 38422473 | Derived | Bardia A, Rugo HS, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Kalinsky K, Cortes J, Shaughnessy JO, Dieras V, Carey LA, Gianni L, Piccart-Gebhart M, Loibl S, Yoon OK, Pan Y, Hofsess S, Phan SC, Hurvitz SA. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. |
| 35545724 | Derived | O'Shaughnessy J, Brufsky A, Rugo HS, Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia A, Henry S, Mayer I, Zhu Y, Phan S, Cortes J. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. |
| 34467774 | Derived | Bardia A, Hurvitz SA, Rugo HS, Brufsky A, Cortes J, Loibl S, Piccart M, Cowden J, Spears P, Carey LA. A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer. Future Oncol. 2021 Oct 1;17(30):3911-3924. doi: 10.2217/fon-2021-0868. Epub 2021 Sep 1. |
| 33882206 | Derived | Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485. |
| 33093337 | Derived | McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671. |
| 33070624 | Derived | Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021 Jul;55(7):921-931. doi: 10.1177/1060028020966548. Epub 2020 Oct 17. |
| FG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
| Enrolled and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) Population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sacituzumab Govitecan | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. |
| BG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population | PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. | The BM-ve Population included all randomized participants who were randomized to the strata of no baseline brain metastasis at the time of randomization. | Posted | Median | 95% Confidence Interval | months | From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Progression-Free Survival (PFS) by IRC Assessment in the ITT Population | PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. | The ITT Population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Overall Survival (OS) in BM-ve Population | Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. | Participants in the BM-ve Population were analyzed. | Posted | Median | 95% Confidence Interval | months | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) |
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| Secondary | Overall Survival (OS) in ITT Population | Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. | Participants in the ITT Population were analyzed. | Posted | Median | 95% Confidence Interval | months | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) |
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| Secondary | Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population | ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions. | Participants in the BM-ve Population with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Time to Objective Response by the Investigator Assessment in BM-ve Population | Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. | Participants in the BM-ve Population with objective response were analyzed. | Posted | Mean | Standard Deviation | months | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Time to Objective Response by the IRC Assessment in BM-ve Population | Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. | Participants in the BM-ve Population with objective response were analyzed. | Posted | Mean | Standard Deviation | months | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population | DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. | Participants in the BM-ve Population with objective response were analyzed. | Posted | Median | 95% Confidence Interval | months | From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Time to Progression (TTP) by Investigator Assessment in BM-ve Population | Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. | Participants in the BM-ve Population were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Time to Progression (TTP) by IRC Assessment in BM-ve Population | Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. | Participants in the BM-ve Population were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population | CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Participants in the BM-ve Population were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) |
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| Secondary | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug | Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:
| Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC. | Posted | Number | percentage of participants | First dose date up to last follow-up (maximum up to 30.8 months) |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score | The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement. | Participants in the Safety analysis set with available data were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline; End of Treatment (EOT) (up to 29.6 months) |
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| Secondary | Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline | Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. | Participants in the Safety analysis set were analyzed. | Posted | Number | percentage of participants | First dose date up to last follow-up (maximum up to 30.8 months) |
|
Adverse Events: First dose date up to last follow-up (maximum up to 30.8 months); All-Cause Mortality: From randomization up to 30.8 months
Serious Adverse Events and Other Adverse Events: Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC.
All-Cause Mortality: The ITT Population included all randomized participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sacituzumab Govitecan | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. | 201 | 267 | 69 | 258 | 256 | 258 |
| EG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. | 222 | 262 | 64 | 224 | 213 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Corynebacterium infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 22.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 22.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Breast ulceration | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
After study conclusion and without prior written approval from Immunomedics and Gilead sciences, investigators in this study may communicate, orally present/publish in scientific journals/other media only after following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2020 | Nov 3, 2021 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
| C490954 | eribulin |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| White |
|
| Other |
|
| Canada |
|
| France |
|
| Germany |
|
| Spain |
|
| United Kingdom |
|
| United States |
|
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).
Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
|
|
|
|
|
|
|
|
|
| Treatment of Physician's Choice (TPC) |
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
|
|
|
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).
Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
|
|
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).
Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
|
|
| OG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
|
|
|
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).
Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
|
|
|
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).
Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
|
|
|
| OG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
|
|
|
| OG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
|
|
| OG001 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
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Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. |
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