Olaparib + Durvalumab for Breast Cancer
(OlympiaN Trial)

Recruiting in Palo Alto (17 mi)

+59 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am 18 years old or older.

I am able to understand and sign the consent form.

+7 more

Exclusion Criteria

I haven't had major surgery in the last 2 weeks.

I haven't taken immunosuppressive drugs in the last 14 days.

I am not taking any strong or moderate drugs that affect liver enzymes.

+12 more

Participant Groups

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.

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).

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: