Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005137-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Myriad Genetic Laboratories, Inc. | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib | Experimental | Olaparib tablet 300mg bd po |
|
| Physician's choice chemotherapy | Active Comparator | Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Second Progression or Death (PFS2) | Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Subsequent Cancer Therapy or Death (TFST) | Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death. | Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Robson, MD | Memorial Sloan-Kettering Cancer Center, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | 92123 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28578601 | Derived | Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4. |
| Label | URL |
|---|---|
| Redacted Protocol | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Screening occurred in 2 parts. Part 1: patients with unknown BRCA status were tested by Myriad. Part 1 screening failures were mostly due to no BRCA1/2 mutation detected. Part 2: patients with a known germline BRCA mutation were screened. 302 patients were randomized.
The first patient was enrolled on 27 March 2014 and the last patient on 30 October 2015. Patients were randomized at 125 centres across 19 countries in North America, South America, Europe and Asia.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib 300 mg bd | |
| FG001 | Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Physician's choice chemotherapy | Drug | Investigators will declare one of the following regimens:
|
|
| Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months. |
| Overall Survival (OS) | Time from randomisation until death due to any cause. | Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months. |
| Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Number of responders according to blinded independent central review (BICR) assessment. Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR. | Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. |
| Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL. | EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months. |
| Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm | Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Assessed in patients with a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis). | Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. |
| Overall Survival (OS) at Final OS | Time from randomisation until death due to any cause. | Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 40 months. |
| Overall Survival (OS) at Extended OS | Time from randomisation until death due to any cause. | Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months. |
| Time to Second Subsequent Cancer Therapy or Death (TSST) |
Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death. |
| Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months. |
| Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS | Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death. | Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months. |
| Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS | Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death. | Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months. |
| Santa Rosa |
| California |
| 95403 |
| United States |
| Research Site | Whittier | California | 90602 | United States |
| Research Site | Denver | Colorado | 80204 | United States |
| Research Site | New Haven | Connecticut | 06510 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Jacksonville | Florida | 32224 | United States |
| Research Site | Orlando | Florida | 32804 | United States |
| Research Site | Plantation | Florida | 33324 | United States |
| Research Site | Columbus | Georgia | 31904 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Chicago | Illinois | 60612 | United States |
| Research Site | Niles | Illinois | 60714 | United States |
| Research Site | Wichita | Kansas | 67214 | United States |
| Research Site | Lafayette | Louisiana | 70506 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Boston | Massachusetts | 02118 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Detroit | Michigan | 48201 | United States |
| Research Site | Grand Rapids | Michigan | 49503 | United States |
| Research Site | Rochester | Minnesota | 55905-0001 | United States |
| Research Site | Saint Louis Park | Minnesota | 55416 | United States |
| Research Site | Jackson | Mississippi | 39202 | United States |
| Research Site | Columbia | Missouri | 65212 | United States |
| Research Site | St Louis | Missouri | 63131 | United States |
| Research Site | Lebanon | New Hampshire | 03756 | United States |
| Research Site | Commack | New York | 11725 | United States |
| Research Site | Harrison | New York | 10604 | United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Rockville Centre | New York | 11570 | United States |
| Research Site | Syracuse | New York | 13210 | United States |
| Research Site | Cincinnati | Ohio | 45267 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| Research Site | Portland | Oregon | 97213 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Sayre | Pennsylvania | 18840 | United States |
| Research Site | Germantown | Tennessee | 38138 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Tyler | Texas | 75701 | United States |
| Research Site | Burlington | Vermont | 05401 | United States |
| Research Site | Plovdiv | 4000 | Bulgaria |
| Research Site | Plovdiv | 4004 | Bulgaria |
| Research Site | Sofia | 1233 | Bulgaria |
| Research Site | Sofia | 1303 | Bulgaria |
| Research Site | Sofia | 1330 | Bulgaria |
| Research Site | Sofia | 1504 | Bulgaria |
| Research Site | Varna | 9010 | Bulgaria |
| Research Site | Vratsa | 3000 | Bulgaria |
| Research Site | Beijing | 100006 | China |
| Research Site | Beijing | 100021 | China |
| Research Site | Beijing | 100142 | China |
| Research Site | Changchun | 130061 | China |
| Research Site | Changsha | 410013 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Dalian | 116011 | China |
| Research Site | Guangzhou | 510060 | China |
| Research Site | Hangzhou | 310022 | China |
| Research Site | Harbin | 150081 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Shanghai | 200025 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shenyang | 110016 | China |
| Research Site | Tianjin | 300060 | China |
| Research Site | Brno | 656 53 | Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 128 08 | Czechia |
| Research Site | Caen | 14076 | France |
| Research Site | Montpellier | 34298 | France |
| Research Site | Rouen | 76038 | France |
| Research Site | Strasbourg | 67065 | France |
| Research Site | Villejuif | 94800 | France |
| Research Site | Budapest | 1032 | Hungary |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Budapest | 1115 | Hungary |
| Research Site | Budapest | 1122 | Hungary |
| Research Site | Budapest | 1145 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Veszprém | 8200 | Hungary |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Roma | 00144 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Rozzano | 20089 | Italy |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Chūōku | 104-8560 | Japan |
| Research Site | Fukuoka | 811-1395 | Japan |
| Research Site | Kagoshima | 892-0833 | Japan |
| Research Site | Nagoya | 464-8681 | Japan |
| Research Site | Osaka | 540-0006 | Japan |
| Research Site | Sapporo | 003-0804 | Japan |
| Research Site | Shinagawa-ku | 142-8666 | Japan |
| Research Site | Suita | 565-0871 | Japan |
| Research Site | Estado de México | 50080 | Mexico |
| Research Site | Mérida | 97000 | Mexico |
| Research Site | Mérida | 97070 | Mexico |
| Research Site | Mérida | 97133 | Mexico |
| Research Site | México | 6760 | Mexico |
| Research Site | San Juan del Río | 76800 | Mexico |
| Research Site | Cusco | CUSCO 01 | Peru |
| Research Site | Lima | LIMA 01 | Peru |
| Research Site | Lima | Lima 18 | Peru |
| Research Site | Lima | LIMA 27 | Peru |
| Research Site | Lima | LIMA 34 | Peru |
| Research Site | Lima | LIMA 41 | Peru |
| Research Site | San Borja | LIMA 41 | Peru |
| Research Site | Elblag | 82-300 | Poland |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Grzepnica | 72-003 | Poland |
| Research Site | Lodz | 93-513 | Poland |
| Research Site | Tarnobrzeg | 39-400 | Poland |
| Research Site | Warsaw | 01-748 | Poland |
| Research Site | Warsaw | 03-291 | Poland |
| Research Site | Bucharest | 011171 | Romania |
| Research Site | Bucharest | 013811 | Romania |
| Research Site | Bucharest | 030171 | Romania |
| Research Site | Cluj-Napoca | 400015 | Romania |
| Research Site | Arkhangelsk | 163045 | Russia |
| Research Site | Ivanovo | 153040 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Omsk | 644013 | Russia |
| Research Site | Saint Petersburg | 191014 | Russia |
| Research Site | Saint Petersburg | 195257 | Russia |
| Research Site | Saint Petersburg | 195271 | Russia |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Saransk | 430005 | Russia |
| Research Site | Yaroslavl | 150054 | Russia |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Daegu | 41404 | South Korea |
| Research Site | Incheon | 21565 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 158-710 | South Korea |
| Research Site | Seoul | 6351 | South Korea |
| Research Site | Barcelona | 08003 | Spain |
| Research Site | Córdoba | 14004 | Spain |
| Research Site | Granada | 18014 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Majadahonda | 28222 | Spain |
| Research Site | Oviedo | 33011 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Zaragoza | 50009 | Spain |
| Research Site | Bern | CH-3010 | Switzerland |
| Research Site | Lausanne | CH-1011 | Switzerland |
| Research Site | Zurich | 8063 | Switzerland |
| Research Site | Kaohsiung City | 80756 | Taiwan |
| Research Site | Taichung | 407 | Taiwan |
| Research Site | Taipei | 10048 | Taiwan |
| Research Site | Taipei | 10449 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Taoyuan | 333 | Taiwan |
| Research Site | Adana | 1260 | Turkey (Türkiye) |
| Research Site | Ankara | 06230 | Turkey (Türkiye) |
| Research Site | Edirne | 22030 | Turkey (Türkiye) |
| Research Site | Gaziantep | 27310 | Turkey (Türkiye) |
| Research Site | Istanbul | 34390 | Turkey (Türkiye) |
| Research Site | Izmir | 35100 | Turkey (Türkiye) |
| Research Site | Kayseri | 38039 | Turkey (Türkiye) |
| Research Site | Konya | 42080 | Turkey (Türkiye) |
| Research Site | Mersin | 33110 | Turkey (Türkiye) |
| Research Site | Aberdeen | AB25 2ZN | United Kingdom |
| Research Site | Colchester | CO4 5JL | United Kingdom |
| Research Site | Coventry | CV2 2DX | United Kingdom |
| Research Site | London | W6 8RF | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Plymouth | PL6 8DH. | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set consisting of all randomized patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib 300 mg bd | |
| BG001 | Chemotherapy | |
| 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 | Median | Full Range | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Receptor status | ER = oestrogen receptor, PgR = progesterone receptor. All patients were HER2 negative. | Count of Participants | Participants |
| |||||||||||||||
| Received prior chemotherapy for metastatic breast cancer | Count of Participants | Participants |
| ||||||||||||||||
| Received prior platinum for breast cancer | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Second Progression or Death (PFS2) | Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Time from randomisation until death due to any cause. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Number of responders according to blinded independent central review (BICR) assessment. Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR. | Evaluable For Response (EFR) Analysis Set consisting of all randomised patients with measurable disease at baseline, i.e. at least one measurable target lesion assessed by blinded independent central review (BICR) | Posted | Number | Participants | Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL. | Subset of Full Analysis Set (FAS) consisting of all randomised patients with an evaluable baseline EORTC QLQ-C30 assessment and at least one evaluable post-baseline assessment | Posted | Mean | 95% Confidence Interval | Score on a scale | EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm | Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Assessed in patients with a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis). | Subset of Full Analysis Set (FAS) consisting of all randomised patients who were confirmed as Myriad CDx gBRCAm | Posted | Median | 95% Confidence Interval | Months | Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to First Subsequent Cancer Therapy or Death (TFST) | Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Second Subsequent Cancer Therapy or Death (TSST) | Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at Final OS | Time from randomisation until death due to any cause. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 40 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at Extended OS | Time from randomisation until death due to any cause. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS | Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS | Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death. | Full Analysis Set (FAS) consisting of all randomised patients | Posted | Median | 95% Confidence Interval | Months | Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months. |
|
|
Adverse events and serious adverse events were collected throughout the study until study completion (up to a maximum of 30 months). They are reported from date of first dose of study treatment until the earliest of 30 days after last dose of study treatment and data cut-off.
Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).
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 | Olaparib 300 mg bd | Description (Arm-group) | 159 | 205 | 37 | 205 | 196 | 205 |
| EG001 | Chemotherapy | Description (Arm-group) | 73 | 97 | 15 | 91 | 85 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | 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 |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | 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 |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Venous thrombosis | 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 |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphopenia | 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 distension | Gastrointestinal 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 |
| |
| Dyspepsia | 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 |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 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 |
| |
| Gamma-glutamyltransferase 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 |
| |
| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | 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 |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal 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 |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric 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 |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Science Director | AstraZeneca | 1-877-240-9479 | clinicaltrialtransparency@astrazeneca.com |
| 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 |
|---|---|
| C531550 | olaparib |
Not provided
Not provided
Not provided
| >=50-<65 |
|
| >=65 |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| CHINA |
|
| CZECH REPUBLIC |
|
| FRANCE |
|
| HUNGARY |
|
| ITALY |
|
| JAPAN |
|
| KOREA |
|
| MEXICO |
|
| PERU |
|
| POLAND |
|
| ROMANIA |
|
| RUSSIAN FEDERATION |
|
| SPAIN |
|
| SWITZERLAND |
|
| TAIWAN |
|
| TURKEY |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| ER and PgR negative |
|
| No |
|
| No |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|