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New pill could beat chemo for BRCA breast cancer

NCT ID NCT02000622

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial compared the pill olaparib to standard chemotherapy in 302 people with metastatic breast cancer who have inherited BRCA1 or BRCA2 mutations. The goal was to see if olaparib could slow cancer growth better than chemo. Participants took olaparib twice daily or received one of three chemo regimens chosen by their doctor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olaparib (a PARP inhibitor taken as a pill)
What this could lead to
If successful, this could offer a targeted, less toxic treatment option for people with BRCA-related metastatic breast cancer, potentially delaying disease progression.
What could go wrong
This is a Phase 3 trial, but results may not apply to all breast cancers. Olaparib may cause side effects like fatigue or nausea, and not all patients may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

302 people

The number who actually took part.

Started

Mar 2014

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRCA 1 gene mutation BRCA 2 gene mutation Breast cancer, metastatic

Contacts and locations

Locations

  • Research Site

    San Diego, California, 92123, United States

  • Research Site

    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

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