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Immunotherapy

Olaparib + Durvalumab for Breast Cancer (OlympiaN Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Documented deleterious or suspected deleterious mutation in BRCA1 or BRCA2 from local BRCA testing
Must not have
Major surgical procedure within 2 weeks of the first dose of study intervention
Participant must not have had any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation, or experimental therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing olaparib alone and in combination with durvalumab for early-stage breast cancer patients with specific genetic markers. Olaparib stops cancer cells from repairing DNA, while durvalumab helps the immune system attack cancer. The goal is to find better treatment options for these patients.

Who is the study for?
This trial is for adults over 18 with newly diagnosed, operable breast cancer that's not spread and has specific characteristics including a BRCA1 or BRCA2 mutation. Participants must be able to use contraception, provide consent, have good organ function, weigh at least 30 kg, and have an ECOG status of 0 or 1. Exclusions include those with certain heart conditions, active hepatitis or autoimmune diseases, HIV unless well-controlled on therapy, prior breast cancer treatments or exposure to certain drugs.
What is being tested?
The study tests Olaparib alone and in combination with Durvalumab in treating HER2 negative BRCA-mutated breast cancer. Olaparib is a PARP inhibitor approved for metastatic cases; Durvalumab is an immunotherapy approved for some lung cancers. Their combined use in breast cancer treatment remains experimental.
What are the potential side effects?
Olaparib may cause nausea, vomiting, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Durvalumab can lead to immune system-related side effects like inflammation of organs (colitis), skin reactions (rash), hormonal gland issues (thyroid dysfunction) and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My tests show a harmful change in my BRCA1 or BRCA2 gene.
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I have a new diagnosis of operable breast cancer that has not spread.
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My organs and bone marrow are functioning well.
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I am willing to have a biopsy before starting the study treatment.
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I weigh at least 30 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 2 weeks.
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I have not received any treatment for my current breast cancer.
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I am not taking any strong or moderate drugs that affect liver enzymes.
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I have a history of irregular heartbeats or uncontrolled heart rhythm problems.
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I have or had an autoimmune or inflammatory disorder.
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I have been diagnosed with MDS or AML.
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I have been treated with specific medications before.
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I am not on any cancer treatments right now.
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I haven't taken strong or moderate CYP3A inhibitors in the last 2 weeks.
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I do not have severe diseases or uncontrolled infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the efficacy, measured by pCR (pathological complete response) rate, of olaparib monotherapy and olaparib plus durvalumab combination therapy, as assessed by central pathology review.
Secondary study objectives
Body Temperature
Pulse rate (heart rate)
Combined Modality Therapy
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
Cohort B will consist of a higher-risk population of participants with HER2-negative ER-negative or ER-low defined as having a tumour size of \>20 mm but ≤50 mm and N0 (T2/N0), or having a tumour size of \>1 mm but ≤20 mm and N1 (T1/N1).
Group II: Cohort AExperimental Treatment1 Intervention
Cohort A will consist of a lower-risk population of participants with HER2-negative ER-negative or ER-low defined as having a tumour size \>5 mm and ≤20 mm and N0 (T1b-c/N0).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
PARP inhibitors, such as Olaparib, work by blocking the PARP enzyme, which is crucial for repairing DNA damage in cells. This is particularly effective in cancer cells with BRCA mutations, as these cells already have compromised DNA repair mechanisms, leading to cell death. Immunotherapy, like Durvalumab, enhances the body's immune response against cancer cells by blocking the PD-L1 protein, which normally helps cancer cells evade immune detection. These treatments are significant for breast cancer patients as they offer targeted approaches that can improve outcomes, especially in cases where traditional therapies may be less effective.
The safety of antiangiogenic agents and PARP inhibitors in platinum-sensitive recurrent ovarian cancer.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,549 Total Patients Enrolled
177 Trials studying Breast Cancer
1,245,158 Patients Enrolled for Breast Cancer
Anitra Fielding, MBChBStudy DirectorAstraZeneca

Media Library

Durvalumab (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05498155 — Phase 2
Breast Cancer Research Study Groups: Cohort A, Cohort B
Breast Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT05498155 — Phase 2
Durvalumab (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498155 — Phase 2
~16 spots leftby Dec 2025