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New drug combo aims to keep advanced breast cancer in check

NCT ID NCT04191135

Disease control Sponsor: Merck Sharp & Dohme LLC 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tested whether a combination of olaparib (a targeted therapy) and pembrolizumab (an immunotherapy) works better than standard chemotherapy plus pembrolizumab for people with advanced triple-negative breast cancer that initially responded to chemo-immunotherapy. The trial enrolled 462 participants and aimed to see if the olaparib combo could delay cancer growth and improve survival. Enrollment was stopped early, but participants already benefiting could continue treatment.

What this could mean

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

Active substance
Olaparib and pembrolizumab
What this could lead to
If successful, this combination could offer a new maintenance treatment option to delay cancer progression and extend survival for people with advanced triple-negative breast cancer.
What could go wrong
This trial was stopped early due to enrollment issues, so results may be limited. The study is also in Phase 2, meaning it is still early and may not confirm benefits in larger populations.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

462 people

The number who actually took part.

Started

Dec 2019

Finished

Nov 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 years and older

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: Induction Period: * Has locally recurrent inoperable TNBC that has not previously been treated with chemotherapy and that cannot be treated with curative intent OR has metastatic TNBC that has not been previously treated with chemotherapy * Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician * Has measurable disease based on RECIST 1.1 * Has provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 7 days prior to the start of induction study treatment * Has a life expectancy ≥27 weeks from the day of first study treatment * Demonstrate adequate organ function within 10 days prior to the start of study treatment * A male participant must agree to be abstinent or use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention (95 days for olaparib and chemotherapy; no requirement for pembrolizumab) * A female participant must not be pregnant or breastfeeding and must agree to the following if is a woman of childbearing potential (WOCBP): have a negative pregnancy test within 24 hours before the start of study treatment and agree to be abstinent or use contraception and refrain from donating eggs (ova, oocytes) during the intervention period and for at least the time needed to eliminate each study intervention (180 days for olaparib and chemotherapy; 120 days for pembrolizumab) Post-induction Period: * Has received up to 6 cycles but not less than 4 cycles of induction therapy without permanently discontinuing from pembrolizumab or both carboplatin and gemcitabine * Has achieved complete response (CR), partial response (PR), or stable disease (SD) based on RECIST 1.1 by Blinded Independent Central Review (BICR) at the Week 18 evaluation * Is able to complete during post-induction at least the Cycle 1, Day 1 doses of olaparib and pembrolizumab or the Cycle 1, Day 1 doses of at least one of the chemotherapy agents being administered at the end of induction (carboplatin and/or gemcitabine) in addition to pembrolizumab * Has ECOG performance status of 0 or 1, as assessed within 7 days prior to the start of post-induction study treatment * Has no higher than Grade 1 toxicities related to induction therapy (excluding alopecia) prior to randomization Exclusion Criteria: Induction Period: * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML * Has a history of (non-infectious) pneumonitis\\interstitial lung disease that required steroids or current pneumonitis\\interstitial lung disease * Has active, or a history of, interstitial lung disease * Has a known history of active tuberculosis * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection * Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of first study treatment * Has neuropathy ≥Grade 2 * Has not recovered (eg, to ≤Grade 1 or to baseline) from AEs due to a previously administered therapy * Has a known history of hypersensitivity or allergy to pembrolizumab, olaparib and any of its components, and/or to any of the study chemotherapies (eg, carboplatin or gemcitabine) and any of their components * Has severe hypersensitivity (≥Grade 3) to the study treatments and/or any of their excipients * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 180 days after the last dose of study treatment * Is a WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation * Has received prior therapy with either olaparib or any other poly adenosine diphosphate ribose polymerase (PARP) inhibitor * Has received prior radiotherapy within 2 weeks of start of study treatment * Has received colony-stimulating factors (eg, granulocyte colony stimulating factor \[G-CSF\], granulocyte macrophage colony stimulating factor \[GM-CSF\] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment * Has had an allogenic tissue/solid organ transplant. * Has received previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT) * Has had major surgery within 2 weeks of starting study treatment or has not recovered from any effects of any major surgery * Has received a live or live-attenuated vaccine within 30 days prior to first study treatment * Is receiving any medication prohibited in combination with study chemotherapies unless medication was stopped within 7 days prior to first study treatment * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137) or has previously participated in a study evaluating pembrolizumab regardless of treatment received * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment * Has presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator * Has a history or current evidence of any condition (eg, cytopenia, transfusion-dependent anemia, or thrombocytopenia), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator * Is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption) * Is unlikely to comply with the study procedures, restrictions, and requirements of the study; as judged by the investigator Post-induction Period: * Has severe hypersensitivity (≥Grade 3) to the study treatments and/or any of their excipients * Has permanently discontinued from both carboplatin and gemcitabine during induction due to toxicity * Has permanently discontinued from pembrolizumab during induction due to toxicity * Has received less than 4 cycles of chemotherapy plus pembrolizumab during induction * Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study * Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 triple-negative breast carcinoma

As listed by the trial registrant

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

Triple negative breast neoplasms

Contacts and locations

Locations

  • Aichi Cancer Center Hospital ( Site 2202)

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ajou University Hospital ( Site 2407)

    Suwon, Kyonggi-do, 16499, South Korea

  • Asan Medical Center ( Site 2404)

    Seoul, 05505, South Korea

  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608)

    Kecskemét, Bács-Kiskun county, 6000, Hungary

  • Barts Health NHS Trust ( Site 0912)

    London, London, City of, EC1M 6BQ, United Kingdom

  • Blackpool Victoria Hospital ( Site 0921)

    Blackpool, Lancashire, FY3 8NR, United Kingdom

  • CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007)

    Metz, Moselle, 57085, France

  • CHU Amiens Hopital Sud ( Site 1023)

    Amiens, Somme, 80000, France

  • CHU-Jean Minjoz ( Site 1013)

    Besançon, Doubs, 25030, France

  • CI Krivorizhskiy oncology dispensery ( Site 1504)

    Kryviy Rih, Dnipropetrovsk Oblast, 50048, Ukraine

  • CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011)

    Laval, Quebec, H7M 3L9, Canada

  • Centre Francois Baclesse ( Site 1012)

    Caen, Calvados, 14076, France

  • Centre Henri Becquerel ( Site 1020)

    Rouen, Seine-Maritime, 76038, France

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003)

    Montreal, Quebec, H2X 3E4, Canada

  • Centre Jean Perrin ( Site 1003)

    Clermont-Ferrand, Puy-de-Dome, 63001, France

  • Centre Leon Berard ( Site 1018)

    Lyon, Rhone, 69373, France

  • Centre de Cancerologie du Grand Montpellier ( Site 1009)

    Montpellier, Languedoc-Roussillon, 34070, France

  • Centro Investigación del Cáncer James Lind ( Site 0510)

    Temuco, Araucania, 4780000, Chile

  • Chernihiv Medical Center of Modern Oncology ( Site 1520)

    Chernihiv, Chernihiv Oblast, 14029, Ukraine

  • China Medical University Hospital ( Site 2302)

    Taipei, 40447, Taiwan

  • Clinica Universitaria Navarra - Madrid ( Site 0700)

    Madrid, 28027, Spain

  • Clinica de la Costa Ltda. ( Site 0600)

    Barranquilla, Atlántico, 080020, Colombia

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)

    Kharkiv, Kharkiv Oblast, 61070, Ukraine

  • Cork University Hospital ( Site 0902)

    Cork, T12 DC4A, Ireland

  • Debreceni Egyetem Klinikai Kozpont ( Site 1600)

    Debrecen, 4032, Hungary

  • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502)

    Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

  • Frauenklinik St. Louise ( Site 1216)

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • Fukushima Medical University Hospital ( Site 2201)

    Fukushima, 960-1295, Japan

  • Fundacion Arturo Lopez Perez ( Site 0500)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)

    Medellín, Antioquia, 050030, Colombia

  • Fundacion Valle del Lili ( Site 0602)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gachon University Gil Medical Center ( Site 2408)

    Incheon, 21565, South Korea

  • Georgia Cancer Center at Augusta University ( Site 0129)

    Augusta, Georgia, 30912, United States

  • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508)

    Kharkiv, Kharkiv Oblast, 61024, Ukraine

  • Gynaekologisch-onkologische Praxis Hannover ( Site 1207)

    Hanover, Lower Saxony, 30177, Germany

  • Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)

    Bonn, North Rhine-Westphalia, 53111, Germany

  • Hemato Oncologos S.A. ( Site 0603)

    Cali, Valle del Cauca Department, 760042, Colombia

  • Henry Ford Health System ( Site 0103)

    Detroit, Michigan, 48202, United States

  • Hiroshima City Hiroshima Citizens Hospital ( Site 2204)

    Hiroshima, 730-8518, Japan

  • Hochwaldkrankenhaus Bad Nauheim ( Site 1211)

    Bad Nauheim, Hesse, 61231, Germany

  • Hospital Clinic I Provincial de Barcelona ( Site 0702)

    Barcelona, 08036, Spain

  • Hospital General Arnau de Vilanova de Valencia ( Site 0706)

    Valencia, Valenciana, Comunitat, 46015, Spain

  • Hospital Universitari Vall d Hebron ( Site 0701)

    Barcelona, 08035, Spain

  • Hospital Universitario Reina Sofia ( Site 0705)

    Córdoba, Andalusia, 14004, Spain

  • Hyogo College of Medicine Hospital ( Site 2203)

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Hôpital Saint-Louis ( Site 1025)

    Paris, 75010, France

  • IC La Serena Research ( Site 0511)

    La Serena, Coquimbo Region, 1720430, Chile

  • Institut Claudius Regaud IUCT Oncopole ( Site 1001)

    Toulouse, Haute-Garonne, 31059, France

  • Institut Gustave Roussy ( Site 1010)

    Villejuif, Val-de-Marne, 94805, France

  • Institut Sainte Catherine ( Site 1026)

    Avignon, Vaucluse, 84918, France

  • Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)

    Barcelona, 08023, Spain

  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601)

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • Jewish General Hospital ( Site 0010)

    Montreal, Quebec, H3T 1E2, Canada

  • John Wayne Cancer Institute ( Site 0111)

    Santa Monica, California, 90404, United States

  • Kaohsiung Chang Gung Memorial Hospital ( Site 2304)

    Kaohsiung City, 83301, Taiwan

  • Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)

    Munich, Bavaria, 80337, Germany

  • Kliniken Essen-Mitte ( Site 1215)

    Essen, North Rhine-Westphalia, 45136, Germany

  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300)

    Taipei, 112, Taiwan

  • Kyungpook National University Chilgok Hospital ( Site 2402)

    Daegu, Taegu-Kwangyokshi, 41404, South Korea

  • MI Precarpathian Clinical Oncology Center ( Site 1506)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

  • MSKCC-Bergen ( Site 0162)

    Montvale, New Jersey, 07645, United States

  • MacKay Memorial Hospital ( Site 2301)

    Taipei, 10449, Taiwan

  • Massachusetts General Hospital ( Site 0155)

    Boston, Massachusetts, 02114, United States

  • McGill University Health Centre ( Site 0002)

    Montreal, Quebec, H4A 3J1, Canada

  • Medical Center Verum ( Site 1501)

    Kyiv, 03039, Ukraine

  • Medical Centre Consilium Medical ( Site 1514)

    Kyiv, Kyivska Oblast, 04050, Ukraine

  • Medical Centre LLC Oncolife ( Site 1510)

    Zaporizhzhya, Zaporizhzhia Oblast, 69104, Ukraine

  • Medical center of the Limited Liability Company Yulis ( Site 1517)

    Zaporizhzhya, Zaporizhzhia Oblast, 69035, Ukraine

  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan-Kettering Cancer Center ( Site 0156)

    New York, New York, 10065, United States

  • Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)

    Commack, New York, 11725, United States

  • Mercy Clinic Oncology and Hematology ( Site 0110)

    Oklahoma City, Oklahoma, 73120, United States

  • Musgrove Park Hospital ( Site 0918)

    Taunton, Somerset, TA1 5DA, United Kingdom

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)

    Gliwice, Silesian Voivodeship, 44-102, Poland

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Site 1908)

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Center ( Site 2406)

    Goyang-si, Kyonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital ( Site 2303)

    Tainan, 704, Taiwan

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research (Site 2200)

    Osaka, 540-0006, Japan

  • North West Cancer Centre ( Site 0922)

    Londonderry, London, City of, BT47 6SB, United Kingdom

  • Oncocentro ( Site 0502)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncomedica S.A. ( Site 0606)

    Montería, Departamento de Córdoba, 230002, Colombia

  • Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609)

    Barranquilla, Atlántico, 080020, Colombia

  • Orszagos Onkologiai Intezet ( Site 1602)

    Budapest, 1122, Hungary

  • Pacific Cancer Care ( Site 0142)

    Monterey, California, 93940, United States

  • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)

    Pécs, Baranya, 7624, Hungary

  • Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909)

    Pleszew, Greater Poland Voivodeship, 65-300, Poland

  • Pontificia Universidad Catolica de Chile ( Site 0501)

    Santiago, Region M. de Santiago, 8330032, Chile

  • Pratia MCM Krakow ( Site 1919)

    Krakow, Lesser Poland Voivodeship, 30-510, Poland

  • Princess Margaret Cancer Centre ( Site 0005)

    Toronto, Ontario, M5G 2M9, Canada

  • Raigmore Hospital ( Site 0915)

    Inverness, Highland, IV2 3UJ, United Kingdom

  • Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)

    Swidnica, Lower Silesian Voivodeship, 58-100, Poland

  • Renovatio Clinical ( Site 0117)

    The Woodlands, Texas, 77380, United States

  • SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)

    Kharkiv, Kharkiv Oblast, 61103, Ukraine

  • Samsung Medical Center ( Site 2405)

    Seoul, 06351, South Korea

  • Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206)

    Offenbach, Hesse, 63069, Germany

  • Seoul National University Bundang Hospital ( Site 2409)

    Seongnam-si, Kyonggi-do, 13605, South Korea

  • Seoul National University Hospital ( Site 2403)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 2401)

    Seoul, 03722, South Korea

  • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)

    Kaposvár, 7400, Hungary

  • St Vincents University Hospital ( Site 0900)

    Dublin, D04 YN63, Ireland

  • St. Joseph Heritage Healthcare ( Site 0104)

    Santa Rosa, California, 95403, United States

  • Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913)

    Gdynia, Pomeranian Voivodeship, 81-519, Poland

  • Texas Oncology - San Antonio Stone Oak ( Site 0166)

    San Antonio, Texas, 78258, United States

  • Texas Oncology-New Braunfels ( Site 0168)

    New Braunfels, Texas, 78130, United States

  • Texas Oncology-San Antonio Medical Center ( Site 0158)

    San Antonio, Texas, 78240, United States

  • Texas Oncology-San Antonio Northeast ( Site 0165)

    San Antonio, Texas, 78217, United States

  • The Center For Cancer And Blood Disorders ( Site 0151)

    Fort Worth, Texas, 76104, United States

  • The Christie NHS Foundation Trust ( Site 0914)

    Manchester, M20 4BX, United Kingdom

  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

    San Francisco, California, 94158, United States

  • Universitaetsklinikum AoeR Duesseldorf ( Site 1210)

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitaetsklinikum Carl Gustav Carus ( Site 1203)

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Erlangen ( Site 1201)

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Mannheim GmbH ( Site 1213)

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • University of Chicago ( Site 0159)

    Chicago, Illinois, 60637, United States

  • University of Miami Sylvester CC ( Site 0146)

    Miami, Florida, 33136, United States

  • Virginia Oncology Associates ( Site 0153)

    Norfolk, Virginia, 23502, United States

  • Virginia Oncology Associates ( Site 0163)

    Newport News, Virginia, 23606, United States

  • Virginia Oncology Associates ( Site 0164)

    Virginia Beach, Virginia, 23456, United States

  • Virginia Piper Cancer Institute ( Site 0157)

    Minneapolis, Minnesota, 55407, United States

  • YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)

    Yakima, Washington, 98902, United States

  • Zala Megyei Szent Rafael Korhaz ( Site 1605)

    Zalaegerszeg, Zala County, 8900, Hungary

  • Zhytomyr Regional Oncology Center ( Site 1515)

    Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

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