Breast Cancer MetastaticPhase 3OlympiADNCT02000622
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
A Phase 3 study testing Olaparib and Physician's choice chemotherapy in people with Breast Cancer Metastatic and BRCA 1 Gene Mutation, run by AstraZeneca at 171 sites in 19 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- What is being tested?
- Olaparib and Physician's choice chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 171 sitesin 19 countries
- Study dates
- 27 Mar 2014to 23 Dec 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
- Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
- Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
- Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
- ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
- ECOG performance status 0-1.
- Adequate bone marrow, kidney and liver function.
Who cannot join
- Prior treatment with PARP inhibitor.
- Patients with HER2 positive disease.
- More than 2 prior lines of chemotherapy for metastatic breast cancer.
- Untreated and/or uncontrolled brain metastases.
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
- Known HIV (Human Immunodeficiency Virus) infection.
- Pregnant or breast-feeding women.
Trial locations and contacts
171 sites in 19 countries.
171 sites in 19 countries
United States42 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02118
Research Site
Boston, Massachusetts, 02215
Research Site
Burlington, Vermont, 05401
Research Site
Chicago, Illinois, 60612
Research Site
Cincinnati, Ohio, 45267
Research Site
Cleveland, Ohio, 44106
Research Site
Cleveland, Ohio, 44195
Research Site
Columbia, Missouri, 65212
Research Site
Columbus, Georgia, 31904
Research Site
Commack, New York, 11725
Research Site
Denver, Colorado, 80204
Research Site
Detroit, Michigan, 48201
Research Site
Germantown, Tennessee, 38138
Research Site
Grand Rapids, Michigan, 49503
Research Site
Harrison, New York, 10604
Research Site
Houston, Texas, 77030
Research Site
Jackson, Mississippi, 39202
Research Site
Jacksonville, Florida, 32224
Research Site
Lafayette, Louisiana, 70506
Research Site
Lebanon, New Hampshire, 03756
Research Site
Marietta, Georgia, 30060
Research Site
New Haven, Connecticut, 06510
Research Site
New York, New York, 10021
Research Site
New York, New York, 10065
Research Site
Niles, Illinois, 60714
Research Site
Orlando, Florida, 32804
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Plantation, Florida, 33324
Research Site
Portland, Oregon, 97213
Research Site
Rochester, Minnesota, 55905-0001
Research Site
Rockville Centre, New York, 11570
Research Site
Saint Louis Park, Minnesota, 55416
Research Site
San Diego, California, 92123
Research Site
Santa Rosa, California, 95403
Research Site
Sayre, Pennsylvania, 18840
Research Site
St Louis, Missouri, 63131
Research Site
Syracuse, New York, 13210
Research Site
Tyler, Texas, 75701
Research Site
Washington D.C., District of Columbia, 20007
Research Site
Whittier, California, 90602
Research Site
Wichita, Kansas, 67214
China15 sites
Research Site
Beijing, 100006
Research Site
Beijing, 100021
Research Site
Beijing, 100142
Research Site
Changchun, 130061
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Dalian, 116011
Research Site
Guangzhou, 510060
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Nanjing, 210009
Research Site
Shanghai, 200025
Research Site
Shanghai, 200032
Research Site
Shenyang, 110016
Research Site
Tianjin, 300060
Russia11 sites
Research Site
Arkhangelsk, 163045
Research Site
Ivanovo, 153040
Research Site
Moscow, 115478
Research Site
Omsk, 644013
Research Site
Saint Petersburg, 191014
Research Site
Saint Petersburg, 195257
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197758
Research Site
Saransk, 430005
Research Site
Yaroslavl, 150054
Japan9 sites
Research Site
Chūōku, 104-0045
Research Site
Chūōku, 104-8560
Research Site
Fukuoka, 811-1395
Research Site
Kagoshima, 892-0833
Research Site
Nagoya, 464-8681
Research Site
Osaka, 540-0006
Research Site
Sapporo, 003-0804
Research Site
Shinagawa-ku, 142-8666
Research Site
Suita, 565-0871
Spain9 sites
Research Site
Barcelona, 08003
Research Site
Córdoba, 14004
Research Site
Granada, 18014
Research Site
Madrid, 28034
Research Site
Majadahonda, 28222
Research Site
Oviedo, 33011
Research Site
Seville, 41013
Research Site
Valencia, 46026
Research Site
Zaragoza, 50009
Turkey (Türkiye)9 sites
Research Site
Adana, 1260
Research Site
Ankara, 06230
Research Site
Edirne, 22030
Research Site
Gaziantep, 27310
Research Site
Istanbul, 34390
Research Site
Izmir, 35100
Research Site
Kayseri, 38039
Research Site
Konya, 42080
Research Site
Mersin, 33110
Bulgaria8 sites
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4004
Research Site
Sofia, 1233
Research Site
Sofia, 1303
Research Site
Sofia, 1330
Research Site
Sofia, 1504
Research Site
Varna, 9010
Research Site
Vratsa, 3000
South Korea8 sites
Research Site
Cheongju-si, 28644
Research Site
Daegu, 41404
Research Site
Incheon, 21565
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 158-710
Research Site
Seoul, 6351
Hungary7 sites
Research Site
Budapest, 1032
Research Site
Budapest, 1083
Research Site
Budapest, 1115
Research Site
Budapest, 1122
Research Site
Budapest, 1145
Research Site
Nyíregyháza, 4400
Research Site
Veszprém, 8200
Peru7 sites
Research Site
Cusco, CUSCO 01
Research Site
Lima, LIMA 01
Research Site
Lima, Lima 18
Research Site
Lima, LIMA 27
Research Site
Lima, LIMA 34
Research Site
Lima, LIMA 41
Research Site
San Borja, LIMA 41
Poland7 sites
Research Site
Elblag, 82-300
Research Site
Gdansk, 80-952
Research Site
Grzepnica, 72-003
Research Site
Lodz, 93-513
Research Site
Tarnobrzeg, 39-400
Research Site
Warsaw, 01-748
Research Site
Warsaw, 03-291
Italy6 sites
Research Site
Bologna, 40138
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Roma, 00144
Research Site
Roma, 00168
Research Site
Rozzano, 20089
Mexico6 sites
Research Site
Estado de México, 50080
Research Site
Mérida, 97000
Research Site
Mérida, 97070
Research Site
Mérida, 97133
Research Site
México, 6760
Research Site
San Juan del Río, 76800
Taiwan6 sites
Research Site
Kaohsiung City, 80756
Research Site
Taichung, 407
Research Site
Taipei, 10048
Research Site
Taipei, 10449
Research Site
Taipei, 11217
Research Site
Taoyuan, 333
United Kingdom6 sites
Research Site
Aberdeen, AB25 2ZN
Research Site
Colchester, CO4 5JL
Research Site
Coventry, CV2 2DX
Research Site
London, W6 8RF
Research Site
Manchester, M20 4BX
Research Site
Plymouth, PL6 8DH.
France5 sites
Research Site
Caen, 14076
Research Site
Montpellier, 34298
Research Site
Rouen, 76038
Research Site
Strasbourg, 67065
Research Site
Villejuif, 94800
Romania4 sites
Research Site
Bucharest, 011171
Research Site
Bucharest, 013811
Research Site
Bucharest, 030171
Research Site
Cluj-Napoca, 400015
Czechia3 sites
Research Site
Brno, 656 53
Research Site
Olomouc, 775 20
Research Site
Prague, 128 08
Switzerland3 sites
Research Site
Bern, CH-3010
Research Site
Lausanne, CH-1011
Research Site
Zurich, 8063
About this study
Official title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
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.
- Being tested
- Olaparib, Physician's choice chemotherapy
- Keywords
- Breast Cancer, Metastatic, Olaparib, BRCA, PARP inhibitor, HER2, chemotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
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.
Physician's choice chemotherapyDrug
Investigators will declare one of the following regimens:
- Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days
- Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days
- Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Olaparib | Experimental | Olaparib tablet 300mg bd po Receives: Drug: Olaparib |
| 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 Receives: Drug: Physician's choice chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study start27 Mar 2014
- Primary completion9 Dec 2016
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Mark Robson, MD, Principal investigator, Memorial Sloan-Kettering Cancer Center, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000622
- Sponsor's protocol ID
- D0819C00003
- Other IDs
- 2013-005137-20
- Acronym
- OlympiAD
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2013
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 28578601
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
- ClinicalTrials.gov ID
- NCT02000622
- Acronym / sponsor ID
- OlympiAD / D0819C00003
- Keywords
- Breast Cancer, Metastatic, Olaparib, BRCA, PARP inhibitor, HER2, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC
- Study start
- 27 Mar 2014 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 22 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olaparib | Experimental | Drug: OlaparibOlaparib tablet 300mg bd po |
| Physician's choice chemotherapy | Active comparator | Drug: Physician's choice chemotherapyCapecitabine 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
- Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
- Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
- Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
- ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Key exclusion criteria (7 listed)
- Prior treatment with PARP inhibitor.
- Patients with HER2 positive disease.
- More than 2 prior lines of chemotherapy for metastatic breast cancer.
- Untreated and/or uncontrolled brain metastases.
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibPatients 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. | Drug | Olaparib |
| Physician's choice chemotherapyInvestigators will declare one of the following regimens: * Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days * Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days * Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days | Drug | Physician's choice chemotherapy |
Primary outcome
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Time frame: 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.
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.
7 secondary outcomes
Time to Second Progression or Death (PFS2)
Time frame: 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 frame: 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)
Time frame: 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)
Time frame: 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 frame: 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 frame: 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 frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28578601Robson 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.
- Redacted ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Robson, MD principal investigator
Memorial Sloan-Kettering Cancer Center, New York
171 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olaparib and Physician's choice chemotherapy in people with Breast Cancer Metastatic and BRCA 1 Gene Mutation, run by AstraZeneca at 171 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 171 sites in United States, China, Russia, Japan, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.