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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003069-33 | EudraCT Number | ||
| 184223 | Registry Identifier | JAPIC CTI | |
| DESTINY-B04 | Other Identifier | Daiichi Sankyo and AstraZeneca |
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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
| AstraZeneca | INDUSTRY |
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This study will compare DS-8201a to physician choice standard treatment.
Participants must have HER2-low breast cancer that has been treated before.
Participants' cancer:
This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants.
The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab deruxtecan | Experimental | HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a |
|
| Physician's Choice | Active Comparator | HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan (DS-8201a) | Drug | DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. | From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | All-cause mortality is defined as all anticipated and unanticipated deaths due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study. | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
Inclusion Criteria:
Is the age of majority in their country
Has pathologically documented breast cancer that:
Has documented radiologic progression (during or after most recent treatment)
Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Research Centers - Chandler II | Chandler | Arizona | 85224 | United States | ||
| Banner MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35665782 | Result | Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/NEJMoa2203690. Epub 2022 Jun 5. | |
| 42340017 |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
All participants had been previously treated with at least 1 and no more than 2 prior lines of chemotherapy in the recurrent or metastatic setting. The treatment chosen for the Physician's Choice arm was based on the label approved in the country of drug administration. The Physician's Choice group was combined to ensure an appropriate sample size for the comparator group.
A total of 557 participants were enrolled and randomized to treatment at 161 study sites in the United States (27 study sites), Japan (18 sites), France (16 sites), China (15 sites), Italy (13 sites), Spain (12 sites), Greece (8 sites), Portugal (8 sites), Republic of Korea (8 sites), Israel (6 sites), Switzerland (6 sites), Austria (4 sites), Belgium (4 sites), Russia (3 sites), Sweden (3 sites), Taiwan (3 sites), Unted Kingdom (3 sites), Canada (2 sites), and Hungary (2 sites).
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Deruxtecan (T-DXd) | Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2020 |
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Parallel model, randomized at a 2:1 ratio
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|
| Capecitabine | Drug | Administered according to label, as one option for Physician's Choice (determined before randomization) |
|
| Eribulin | Drug | Administered according to label, as one option for Physician's Choice (determined before randomization) |
|
| Gemcitabine | Drug | Administered according to label, as one option for Physician's Choice (determined before randomization) |
|
| Paclitaxel | Drug | Administered according to label, as one option for Physician's Choice (determined before randomization) |
|
| Nab-paclitaxel | Drug | Administered according to label, as one option for Physician's Choice (determined before randomization) |
|
| From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
| Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. | From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
| Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients) | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. | From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
| Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
| Number of Overall Survival Events (Deaths) | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
| Overall Survival (OS) in All Patients | Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
| Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. | From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years |
| Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients) | Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. | From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years |
| Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. | From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years |
| Duration of Response in Participants With HER2-low Breast Cancer (All Patients) | Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. | From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Cancer Treatment Centers of America at Western Regional Medical Center | Goodyear | Arizona | 85338 | United States |
| UCLA School of Medicine | Los Angeles | California | 90095 | United States |
| Stanford Cancer Institute | Palo Alto | California | 94305 | United States |
| Cancer Care Associates Medical Group, Inc. TORI | Redondo Beach | California | 90277 | United States |
| University of California at San Francisco (PARENT) | San Francisco | California | 94158 | United States |
| Eastern Connecticut Hematology/Oncology Assoc. | Norwich | Connecticut | 06360 | United States |
| Christiana Care Health Services, Inc. | Newark | Delaware | 19713 | United States |
| Sylvester Comprehensive Cancer Center - Deerfield Beach | Boca Raton | Florida | 33426 | United States |
| Florida Cancer Specialists (South Region) | Fort Myers | Florida | 33916 | United States |
| Memorial Healthcare System MRH Cancer Center | Hollywood | Florida | 33021 | United States |
| Orlando Health, Inc. | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center -Tampa | Tampa | Florida | 33139 | United States |
| Cancer Treatment Centers of America-Georgia | Newnan | Georgia | 30263 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Cancer Treatment Centers of America | Zion | Illinois | 60099 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Touro Infirmary | New Orleans | Louisiana | 70115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Hospital | New York | New York | 10065 | United States |
| Weill Cornell Medicine Breast Center | New York | New York | 10065 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania | 15219 | United States |
| St Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Brig Center for Cancer Care and Survivorship | Knoxville | Tennessee | 37909 | United States |
| Baptist Cancer Center | Memphis | Tennessee | 38120 | United States |
| Tennessee Oncology - Skyline Satellite | Nashville | Tennessee | 37201 | United States |
| BloomTrials Clinical Research, LLC | Dallas | Texas | 75234 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics | Houston | Texas | 77030 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria |
| Kepler Universitätsklinikum | Linz | 4020 | Austria |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | 5020 | Austria |
| AKH - Medizinische Universität Wien (4305) | Vienna | 1090 | Austria |
| Klinikum Wels-Grieskirchen GmbH | Wels | 4600 | Austria |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Grand Hôpital de Charleroi | Loverval | 6280 | Belgium |
| CHU UCL Namur | Namur | 5000 | Belgium |
| Centre Hospitalier Wallonie picarde - Site IMC | Tournai | 7500 | Belgium |
| Tom Baker Cancer Center | Calgary | Alberta | T2N4N2 | Canada |
| Toronto Sunnybrook Hospital | Toronto | Ontario | M4N 3M5 | Canada |
| McGill University - Dept. Oncology Clinical Research Program | Montreal | Quebec | H2W 1S6 | Canada |
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA | Fuzhou | Fujian | 350025 | China |
| Sun Yat-sen Memorial hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| The Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu | 210008 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | 110042 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia Hui | 750004 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276001 | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 20032 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Institut Paoli Calmettes | Marseille | Bouches-du-Rhône | 13009 | France |
| Centre François Baclesse | Caen | Calvados | 14076 | France |
| CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie | Plérin | Cotes d'Armor | 22190 | France |
| CHU Brest - Hôpital Morvan | Brest | Finistere | 29609 | France |
| Institut Bergonié | Bordeaux | Gironde | 33076 | France |
| Clinique Clementville | Montpellier | Herault | 34070 | France |
| Institut Régional du Cancer de Montpellier | Montpellier | Herault | 34298 | France |
| CRLCC Eugene Marquis | Rennes | Ille Et Vilaine | 35042 | France |
| ICO - Site René Gauducheau | Saint-Herblain | Loire Atlantique | 44805 | France |
| Centre Hospitalier Emile Roux | Le Puy-en-Velay | Loiret | 43012 | France |
| ICO - Site Paul Papin | Angers | Maine Et Loire | 49055 | France |
| Centre Hospitalier Valenciennes | Valenciennes | Nord | 59322 | France |
| Hôpital Saint-Louis - Paris | Paris | Paris | 75475 | France |
| Clinique Victor Hugo - Centre Jean Bernard | Le Mans | Sarthe | 72015 | France |
| Institut Sainte Catherine | Avignon | Vaculuse | 84918 | France |
| Hôpital d'Instruction des Armees Begin* | Saint-Mandé | Val De Marne | 94160 | France |
| Institut Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
| Institut Curie - site de Paris | Paris | 75005 | France |
| Hopital Tenon | Paris | 75020 | France |
| Universitaetsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Klinikum der Universitaet Muenchen - Campus Grosshardern | Munich | Bavaria | 81377 | Germany |
| General Hospital of Athens "Alexandra" | Athens | 11528 | Greece |
| General Oncology Hospital of Kifissia " Agioi Anargyroi" | Athens | 14564 | Greece |
| Athens Medical Center | Athens | 15125 | Greece |
| University General Hospital of Heraklion | Heraklion | 71110 | Greece |
| University General Hospital of Larissa | Larissa | 41110 | Greece |
| Bioclinic Thessaloniki | Thessaloniki | 54622 | Greece |
| Euromedica General Clinic Thessaloniki | Thessaloniki | 54645 | Greece |
| General Hospital Papageorgiou | Thessaloniki | 56429 | Greece |
| Interbalkan Hospital of Thessaloniki | Thessaloniki | 57001 | Greece |
| Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet | Budapest | 1097 | Hungary |
| Orszagos Onkologiai Intezet | Budapest | 1122 | Hungary |
| Debreceni Egyetem | Debrecen | 4032 | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Gyula | 5700 | Hungary |
| SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok | 5004 | Hungary |
| Rambam Health Care Center | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 49100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52363 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Ziv Medical Center | Safed | 13100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Azienda Ospedaliera Card. G. Panico | Tricase | Lecce | 73039 | Italy |
| Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) | Monza | Milano | 20900 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Ospedale Sacro Cuore Don Calabria | Negrar | Verona | 37024 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | 25100 | Italy |
| Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico | Catania | 95125 | Italy |
| Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario | Catanzaro | 88100 | Italy |
| IEO Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | 80131 | Italy |
| Ospedale degli Infermi | Rimini | 47923 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Roma | 00133 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| NHO Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| NHO Kyushu Cancer Center | Fukuoka | Fukuoka | 811-1395 | Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Hiroshima | 730-8518 | Japan |
| NHO Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Hyogo College of Medicine Hospital | Nishinomiya-shi | Hyōgo | 663-8501 | Japan |
| Hakuaikai Sagara Hospital | Kagoshima | Kagoshima-ken | 892-0833 | Japan |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| NHO Osaka National Hospital | Osaka | Osaka | 540-0006 | Japan |
| Kindai University Hospital | Onohigashi | Osakasayama-shi | 589-8511 | Japan |
| Saitama Cancer Center | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Cancer Institute Hospital of JFCR | Kōtoku | Tokyo-To | 135-8550 | Japan |
| Toranomon Hospital | Minatoku | Tokyo-To | 105-8470 | Japan |
| Showa University Hospital | Shinagawa-Ku | Tokyo-To | 142-8666 | Japan |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Centro Hospitalar do Alto do Ave, EPE | Guimarães | 4835-044 | Portugal |
| Fundação Champalimaud | Lisbon | 1400-038 | Portugal |
| Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) | Matosinhos Municipality | 4464-509 | Portugal |
| Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António | Porto | 4099-001 | Portugal |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Porto | 4200-072 | Portugal |
| Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião | Santa Maria da Feira | 4520-211 | Portugal |
| Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E | Vila Nova de Gaia | 4434-502 | Portugal |
| Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE | Vila Real | 5000-508 | Portugal |
| FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" | Moscow | 115478 | Russia |
| SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement | Moscow | 143423 | Russia |
| SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital" | Yaroslavl | 150054 | Russia |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Inha University Hospital | Incheon | Gyeonggi-do | 22332 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | 361-711 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| ICO l'Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario Donostia | San Sebastián | Guipuzcoa | 20014 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | La Coruña | 15006 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Quironsalud Barcelona | Barcelona | 08023 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| MD Anderson Cancer Centre | Madrid | 28033 | Spain |
| Hospital Ruber Internacional | Madrid | 28034 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Instituto Valenciano de Oncologia IVO | Valencia | 46009 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Karolinska universitetssjukhuset - Solna | Solna | 17176 | Sweden |
| Länssjukhuset Sundsvall-Härnösand | Sundsvall | 85186 | Sweden |
| Akademiska Sjukhuset | Uppsala | 75185 | Sweden |
| Hirslanden Medical Center | Aarau | 5000 | Switzerland |
| Universitaetsspital Basel | Basel | 4031 | Switzerland |
| Kantonsspital Graubuenden | Chur | 7000 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
| Universitaetsspital Zuerich | Zurich | 8091 | Switzerland |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Queen Mary University of London | London | Greater London | EC1M 6BQ | United Kingdom |
| University College London Hospitals | London | Greater London | NW1 2PG | United Kingdom |
| Royal Free Hospital | London | Greater London | NW3 2QG | United Kingdom |
| Western General Hospital | Edinburgh | Lothian Region | EH4 2XU | United Kingdom |
| Nottingham University Hospitals City Campus | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Royal Surrey County Hospital | Guildford | Surrey | GU2 7XX | United Kingdom |
| Derived |
| Iyengar AR, Downs EP, Mehta S, Rangarajan N, Woo MS, Sredni ST, Donato RD, Simsek S, Wilson DM, Krieser K, Patzke EB, Kyek N, Anderson C, Wagner T, Hipp J, Nassar A, Barman H. HER2-Ultralow: Prevalence, Characteristics, and Treatment Choices Among Advanced Breast Cancer Patients With Tumors Initially Scored as IHC 0. Breast J. 2026;2026(1):e7212120. doi: 10.1155/tbj/7212120. |
| 41062831 | Derived | Modi S, Jacot W, Iwata H, Park YH, Vidal Losada M, Li W, Tsurutani J, Ueno NT, Zaman K, Prat A, Papazisis K, Rugo HS, Yamashita T, Harbeck N, Im SA, De Laurentiis M, Pierga JY, Wang X, Gombos A, Tokunaga E, Orbegoso Aguilar C, Yung L, Xiao F, Cheng Y, Cameron D. Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial. Nat Med. 2025 Dec;31(12):4205-4213. doi: 10.1038/s41591-025-03981-4. Epub 2025 Oct 8. |
| 40349139 | Derived | Ueno NT, Cottone F, Dunton K, Jacot W, Yamashita T, Sohn J, Tokunaga E, Prat A, Tsurutani J, Park YH, Rugo HS, Xu B, Cardoso F, Mitri Z, Mahtani R, Aguilar CO, Xiao F, Harbeck N, Cameron DA, Modi S. Patient-reported outcomes from DESTINY-Breast04: trastuzumab deruxtecan versus physician's choice of chemotherapy in patients with HER2-low mBC. Oncologist. 2025 May 8;30(5):oyaf048. doi: 10.1093/oncolo/oyaf048. |
| 38884900 | Derived | Yamashita T, Sohn JH, Tokunaga E, Niikura N, Park YH, Lee KS, Chae YS, Xu B, Wang X, Im SA, Li W, Lu YS, Aguilar CO, Nishijima S, Nishiyama Y, Sugihara M, Modi S, Tsurutani J. Trastuzumab deruxtecan versus treatment of physician's choice in previously treated Asian patients with HER2-low unresectable/metastatic breast cancer: subgroup analysis of the DESTINY-Breast04 study. Breast Cancer. 2024 Sep;31(5):858-868. doi: 10.1007/s12282-024-01600-7. Epub 2024 Jun 17. |
| 38442809 | Derived | Ma R, Shi Y, Yan R, Yin S, Bu H, Huang J. Efficacy and safety of trastuzumab deruxtecan in treating human epidermal growth factor receptor 2-low/positive advanced breast cancer:A meta-analysis of randomized controlled trials. Crit Rev Oncol Hematol. 2024 Apr;196:104305. doi: 10.1016/j.critrevonc.2024.104305. Epub 2024 Mar 3. |
| 37597578 | Derived | Jhaveri K, Eli LD, Wildiers H, Hurvitz SA, Guerrero-Zotano A, Unni N, Brufsky A, Park H, Waisman J, Yang ES, Spanggaard I, Reid S, Burkard ME, Vinayak S, Prat A, Arnedos M, Bidard FC, Loi S, Crown J, Bhave M, Piha-Paul SA, Suga JM, Chia S, Saura C, Garcia-Saenz JA, Gambardella V, de Miguel MJ, Gal-Yam EN, Rapael A, Stemmer SM, Ma C, Hanker AB, Ye D, Goldman JW, Bose R, Peterson L, Bell JSK, Frazier A, DiPrimeo D, Wong A, Arteaga CL, Solit DB. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial. Ann Oncol. 2023 Oct;34(10):885-898. doi: 10.1016/j.annonc.2023.08.003. Epub 2023 Aug 18. |
| 37207306 | Derived | Rugo HS, Crossno CL, Gesthalter YB, Kelley K, Moore HB, Rimawi MF, Westbrook KE, Buys SS. Real-World Perspectives and Practices for Pneumonitis/Interstitial Lung Disease Associated With Trastuzumab Deruxtecan Use in Human Epidermal Growth Factor Receptor 2-Expressing Metastatic Breast Cancer. JCO Oncol Pract. 2023 Aug;19(8):539-546. doi: 10.1200/OP.22.00480. Epub 2023 May 19. |
| 36780610 | Derived | Narayan P, Dilawari A, Osgood C, Feng Z, Bloomquist E, Pierce WF, Jafri S, Kalavar S, Kondratovich M, Jha P, Ghosh S, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer. J Clin Oncol. 2023 Apr 10;41(11):2108-2116. doi: 10.1200/JCO.22.02447. Epub 2023 Feb 13. |
| FG001 | Physician's Choice | Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines. |
| Full Analysis Set (All Randomized Patients) |
|
| Safety Analysis Set (All Randomized Patients Who Received at Least 1 Dose of Study Treatment) |
|
| COMPLETED | Ongoing as of 11 Jan 2022 |
|
| NOT COMPLETED |
|
|
Baseline characteristics were assessed in the Full Analysis Set. The Full Analysis Set included all participants randomized into the study, including those who did not receive a dose of study treatment. Participants were analyzed according to the treatments and strata assigned at randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab Deruxtecan (T-DXd) | Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes. |
| BG001 | Physician's Choice | Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | 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) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. | Progression-free survival (PFS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
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| Secondary | Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. | Progression-free survival (PFS) was assessed in the Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
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| Secondary | Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. | Progression-free survival (PFS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
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| Secondary | Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients) | Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method. | Progression-free survival (PFS) was assessed in the Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years |
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| Secondary | Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. | Overall survival (OS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
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| Secondary | Number of Overall Survival Events (Deaths) | Overall survival events (deaths) were analyzed in the Full Analysis Set (defined as all randomized participants). | Posted | Number | events (deaths) | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
|
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| Secondary | Overall Survival (OS) in All Patients | Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive. | Overall survival (OS) was assessed in the Full Analysis Set (defined as all randomized participants). | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
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| Secondary | Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. | Best overall response and confirmed objective response rate were assessed in the Hormone Receptor-Positive cohort of Full Analysis Set. | Posted | Count of Participants | Participants | From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years |
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| Secondary | Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients) | Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment. Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment. | Best overall response and confirmed objective response rate were assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years |
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| Secondary | Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer | Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. | Duration of response was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years |
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| Secondary | Duration of Response in Participants With HER2-low Breast Cancer (All Patients) | Duration of Response (DoR) is defined as the date of the first documented objective response (complete response [CR] or partial response [PR]) to the first documented disease progression or death, whichever occurs first. DoR was based on blinded independent central review (BICR) and investigator assessment. Median was from Kaplan-Meier estimate. Confidence interval for median was computed using the Brookmeyer-Crowley method. | Duration of response was assessed in the Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years |
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| Other Pre-specified | All-Cause Mortality | All-cause mortality is defined as all anticipated and unanticipated deaths due to any cause, with the number and frequency of such events by arm or comparison group of the clinical study. | All-cause mortality was assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | From the date of randomization up to the date of death due to any cause, up to approximately 3 years |
|
Adverse events (AEs) were collected from the time of signing the main informed consent form up to 40 days (+7 days) after the last treatment, whether observed by the investigator or reported by the participant, up to approximately 3 years in the Safety Analysis Set.
All-cause mortality was assessed in all participants who were randomized (Full Analysis Set). Please refer to the other prespecified outcome measure that also reports all-cause mortality from the Safety Analysis Set. Other AEs and SAEs were assessed in the Safety Analysis Set. The Physician's Choice (PC) treatment was based on the label approved in each country. As prespecified in the protocol for safety analysis, the PC group was combined for an appropriate sample size for the comparator group.
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 | Trastuzumab Deruxtecan (T-DXd) | Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes. | 149 | 373 | 103 | 371 | 366 | 371 |
| EG001 | Physician's Choice | Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines. | 90 | 184 | 43 | 172 | 167 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Chemical peritonitis | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Movement disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Social problem | Social circumstances | MedDRA 24.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
| Jan 11, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
| D000069287 | Capecitabine |
| C490954 | eribulin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| Missing |
|
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
|
|
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
|
|
|
|
|
|
| Participants |
|
|
|
|
| OG001 |
| Physician's Choice |
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines. |
|
|
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|