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Could a Two-Drug combo wipe out breast cancer before surgery?

NCT ID NCT05498155

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether giving olaparib (a PARP inhibitor) alone or combined with durvalumab (an immunotherapy) before surgery can eliminate or shrink tumors in people with BRCA-mutated, HER2-negative early breast cancer. Participants receive one of the two treatments for 4–6 months before their planned surgery. The goal is to see if these drugs can destroy cancer cells by exploiting DNA repair weaknesses and boosting the immune system's attack on the tumor.

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 durvalumab
What this could lead to
If successful, this approach could shrink or eliminate tumors before surgery, potentially improving long-term outcomes for people with BRCA-mutated breast cancer.
What could go wrong
This is a phase 2 trial with only 50 participants, so results may not apply to everyone. Side effects from the drugs or the combination could occur, and the treatment may not work as hoped.

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

50 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Dec 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.

Inclusion Criteria: * Males or Females ≥18 years * Minimum body weight of 30 kg * Capable of giving signed informed consent. * Male and Female participants of childbearing potential must use effective methods of contraception * Histologically confirmed, newly diagnosed, primary, operable, nonmetastatic invasive breast cancer with the following characteristics: --ER-negative or ER-low defined as IHC nuclear staining ≤10% * HER2-negative (not eligible for anti-HER2 therapy) defined as: * IHC 0, 1+ without in situ hybridization OR * In situ hybridization non-amplified with ratio less than 2.0 OR * In situ hybridization average HER2 copy number \< 6 signals/cells * Clinical TNM staging (per AJCC 8th Edition) as follows: * T1b (\>5 mm but ≤10 mm), N0, no known metastases (M0 or MX); OR * T1c (\>10 mm but ≤20 mm), N0, no known metastases (M0 or MX); OR * T1 (\>1 mm but ≤20 mm), N1, no known metastases (M0 or MX); OR * T2 (\>20 mm but ≤50 mm), N0, no known metastases (M0 or MX).). * Documented deleterious or suspected deleterious mutation in BRCA1 or BRCA2 from local BRCA testing using either a germline or tumour test. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must have adequate organ and bone marrow function * Participant must be willing to undergo a baseline research biopsy prior to start of study treatment. * Participant must be willing to have any leftover tumour tissue/FFPE from the diagnostic biopsy submitted for research purposes, if available. Exclusion Criteria: * Any evidence of other diseases (such as severe or uncontrolled systemic diseases or active, uncontrolled infections, including but not limited to, uncontrolled ventricular arrhythmia, uncontrolled hypertension, recent \[within 3 months\] myocardial infarction, uncontrolled major seizure disorder, renal transplant, active bleeding diseases, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan * Refractory nausea and vomiting, chronic gastrointestinal disease likely to interfere with absorption of the study medication, inability to swallow the formulated product * History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence * Participants with MDS or AML * For higher risk (Cohort B) participants only: Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis * Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody * Known to have tested positive for human immunodeficiency virus unless currently on effective anti-retroviral therapy with an undetectable viral load within 6 months * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia * Participant must not have had any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation, or experimental therapy * For higher risk (Cohort B) participants only: Prior exposure to anti-PD1, anti-PD-L1, or anti-CTLA4 agents (ICIs); OR an agent directed to other co-inhibitory or co-stimulatory T-cell receptors * Any concurrent anticancer treatment * Major surgical procedure (excluding placement of vascular access, local surgery of isolated lesions, or diagnostic staging) within 2 weeks of the first dose of study intervention * For higher risk (Cohort B) participants only: Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. * Concomitant use of: * Known strong cytochrome P450 (CYP3A) inhibitors or moderate CYP3A inhibitors within 2 weeks prior to first dose of study intervention * Known strong CYP3A inducers or moderate CYP3A inducers .The required washout period prior to starting study therapy is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Research Site

    Greeley, Colorado, 80631, United States

  • Research Site

    Loveland, Colorado, 80537, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Portland, Oregon, 97239, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Rankweil, 6830, Austria

  • Research Site

    Salzburg, 5020, Austria

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Augsburg, by, 86156, Germany

  • Research Site

    Cologne, 50931, Germany

  • Research Site

    Essen, 45130, Germany

  • Research Site

    Hamburg, 20246, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Heidelberg, 69120, Germany

  • Research Site

    München, 81377, Germany

  • Research Site

    Jerusalem, 91120, Israel

  • Research Site

    Kfar Saba, 44218, Israel

  • Research Site

    Ramat Gan, 5262000, Israel

  • Research Site

    Rehovot, 76100, Israel

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Modena, 41124, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    A Coruña, 15006, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Cáceres, 10003, Spain

  • Research Site

    Hospitalet deLlobregat, 08907, Spain

  • Research Site

    Lleida, 25198, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Valencia, 46010, Spain

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

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