New hope for aggressive breast cancer: drug cocktails show promise in trial

NCT ID NCT03330847

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This Phase 2 study tests whether adding another drug (ceralasertib or adavosertib) to the standard drug olaparib works better than olaparib alone for people with metastatic triple-negative breast cancer. The trial includes 273 adults whose cancer has specific genetic changes. One combination arm was stopped early due to side effects, but the other is still being studied. The goal is to see if these combos can slow cancer growth.

What this could mean

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

Active substance: Olaparib, ceralasertib, adavosertib
What this could lead to: If successful, this trial could point toward more effective combination treatments for metastatic triple-negative breast cancer, especially in patients with specific genetic mutations.
What could go wrong: This is a Phase 2 trial, so results are still early. One combination arm was already closed due to safety concerns, and the study is not blinded, which may introduce bias. Success is not guaranteed.

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

273 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Oct 2026

An estimate. End dates often move.

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 130 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.

Pertinent Inclusion criteria: 1. Informed consent prior to any study specific procedures. 2. Male or female ≥18 years of age. 3. Progressive cancer at the time of study entry. 4. Histologically or cytologically confirmed TNBC at initial diagnosis with evidence of metastatic disease and HER2 negative as per ASCO-CAP HER2 guideline recommendations 2013. 5. Patients must have received at least 1 and no more than 2 prior lines of treatment for metastatic disease with an anthracycline (eg, doxorubicin, epirubicin) and/or a taxane (eg, paclitaxel, docetaxel) unless contraindicated, in either the neo-adjuvant, adjuvant or metastatic setting. 6. Confirmed presence of qualifying HRR mutation or absence of any HRR mutation in tumour tissue by the Lynparza HRR assay. 7. At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging \[MRI\] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1. 8. Patients must have normal organ and bone marrow function measured within 28 days prior to randomization (defined in the protocol). 9. ECOG PS 0-1 within 28 days of randomisation. 10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential (contraception restrictions apply to participants and their partners). 13\. Patient is willing to comply with the protocol requirements. 14. Life expectancy of ≥16 weeks. Pertinent Exclusion criteria: 1. Cytotoxic chemotherapy, hormonal or non hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 21 or more days before Cycle 1 Day 1. The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 5 days prior to study treatment. 2. More than 2 prior lines of cytotoxic chemotherapy for metastatic disease (prior treatments with hormonal, non-hormonal, biologics or the combination of an aromatase inhibitor and everolimus are not counted as a prior line of therapy). 3. Previous randomisation in the present study. 4. Previous treatment with a PARP inhibitor (including olaparib) or other DDR inhibitor (unless less than 3 weeks duration and at least 12 months has elapsed between the last dose and randomization). 5. Exposure to a small molecule IP within 30 days or 5 half-lives (whichever is longer) prior to randomisation. The minimum washout period for immunotherapy shall be 42 days. 6. Patients with second primary cancer (exceptions defined in the protocol). 7. Mean resting corrected QTc interval using the Fridericia formula (QTcF) \>470 msec/female patients and \>450 msec for male patients (as calculated per institutional standards) obtained from 3 ECGs performed 2-5 minutes apart at study entry, or congenital long QT syndrome. 8. Any of the following cardiac diseases currently or within the last 6 months: unstable angina pectoris, congestive heart failure ≥ Class 2 as defined by the New York Heart Association, acute myocardial infarction, conduction abnormality not controlled with pacemaker or medication (patients with a conduction abnormality controlled with pacemaker or medication at the time of screening are eligible), significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible). 9. Concomitant use of known strong or moderate cytochrome P (CYP) 3A inhibitors, strong or moderate CYP3A inducers, or sensitive CYP3A4 substrates or CYp3A4 substrates with a narrow therapeutic index (No longer applicable from CSPv7.0). 10. Persistent toxicities (≥ CTCAE grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy. 11. Major surgery within 2 weeks of starting study treatment: patients must have recovered from any effects of any major surgery. 12. Immunocompromised patients, eg, human immunodeficiency virus (HIV). 13. Patients with known active hepatitis (ie, hepatitis B or C). 14. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease or active, uncontrolled infection. 15. Patients with symptomatic uncontrolled brain metastases. 16. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 17. Patients with a known hypersensitivity to olaparib, adavosertib, Ceralasertib, or any of the excipients of the products. 18. Pregnant or breast feeding women.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

Metastatic triple-negative breast cancer

Contacts and locations

Locations

Research Site

Birmingham, Alabama, 35205, United States
Research Site

Anchorage, Alaska, 99508, United States
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Gilbert, Arizona, 85234, United States
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Aurora, Colorado, 80045, United States
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New Haven, Connecticut, 06511, United States
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Chicago, Illinois, 60637, United States
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Munster, Indiana, 46321, United States
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Hazard, Kentucky, 41701, United States
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Louisville, Kentucky, 40207, United States
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Towson, Maryland, 21204, United States
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Brick, New Jersey, 08724, United States
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East Setauket, New York, 11733, United States
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Lake Success, New York, 11042, United States
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Mineola, New York, 11501, United States
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Mount Kisco, New York, 10549, United States
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Stony Brook, New York, 11794, United States
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Cincinnati, Ohio, 45219, United States
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Knoxville, Tennessee, 37909, United States
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Seattle, Washington, 98104, United States
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Milwaukee, Wisconsin, 53212, United States
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Brasschaat, 2930, Belgium
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Brussels, 1000, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Ottignies, 1340, Belgium
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Wilrijk, 2610, Belgium
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Calgary, Alberta, T2N 4N2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Brno, 625 00, Czechia
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Olomouc, 775 20, Czechia
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Prague, 180 81, Czechia
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Angers, 49055, France
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Besançon, 25030, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Lille, 59000, France
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Lyon, 69373, France
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Marseille, 13273, France
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Montpellier, 34298, France
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Nantes, 44202, France
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Rennes, 35000, France
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Saint-Herblain, 44805, France
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Tours, 37044, France
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Villejuif, 94805, France
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Dresden, 1307, Germany
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Frankfurt am Main, 60431, Germany
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Hamburg, 20357, Germany
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Hanover, 30559, Germany
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Leipzig, 04103, Germany
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München, 81675, Germany
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Witten, 58452, Germany
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Cork, T12 DV56, Ireland
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Dublin, Ireland
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Ancona, 60126, Italy
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Bologna, 40138, Italy
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Brescia, 25124, Italy
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Cona, 44124, Italy
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Genova, 16128, Italy
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Lecco, 23900, Italy
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Meldola, 47014, Italy
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Messina, 98124, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Novara, 28100, Italy
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Parma, 43126, Italy
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Pavia, 27100, Italy
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Pisa, 56126, Italy
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Province of Macerata, 62100, Italy
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Roma, 00128, Italy
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Rozzano, 20089, Italy
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Siena, 53100, Italy
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Torino, 10123, Italy
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Breda, 4819 EV, Netherlands
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Rotterdam, 3015 GD, Netherlands
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The Hague, 2545 CH, Netherlands
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Dąbrowa Górnicza, 41-300, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-519, Poland
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Grzepnica, 72-003, Poland
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Krakow, 31-531, Poland
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Lodz, 91-211, Poland
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Olsztyn, 10-228, Poland
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Poznan, 60-192, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Lisbon, 1400-038, Portugal
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Lisbon, 1769-001, Portugal
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Loures, 2674-514, Portugal
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Porto, 4099-001, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Cheongju-si, 28644, South Korea
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Daegu, 41404, South Korea
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Goyang-si, 410-769, South Korea
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Incheon, 405-760, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Cáceres, 10003, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
Research Site

Palma de Mallorca, 07120, Spain
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San Sebastián, 20014, Spain
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Sant Cugat del Vallès, 08190, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Vigo, 36312, Spain
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Zaragoza, 50009, Spain
Research Site

Changhua, 500, Taiwan
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Kaohsiung Hsien, 83342, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 11490, Taiwan
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Taoyuan, 333, Taiwan
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Aberdeen, AB25 2ZN, United Kingdom
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Bristol, BS1 2NT, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Durham, DH1 5TW, United Kingdom
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Edinburgh, EH4 2XR, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, SE1 9RT, United Kingdom
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London, W1G 6AD, United Kingdom
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London, W1T 7HA, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Southampton, SO16 6YD, United Kingdom

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