Olaparib for Breast Cancer

(OlympiA Trial)

Recruiting in Palo Alto (17 mi)

+601 other locations

Overseen by Judy Garber, Doctor of Medicine

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Research Team

Charles Geyer, Doctor of Medicine

Principal Investigator

Virginia Commonwealth University Massey Cancer Center, McGlothlin Medical Education Center, Room 12-217, 1201 East Marshall St., PO Box 980070, Richmond, VA 23298-0070, USA

Andrew Tutt, Doctor of Medicine

Principal Investigator

Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK

Judy Garber, Doctor of Medicine

Principal Investigator

Harvard Medical School, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Susan F. Smither Center for Women's Cancers, 450 Brookline Avenue, Boston; MA 02215, US

Eligibility Criteria

This trial is for adults with high-risk HER2 negative breast cancer who have a BRCA1/2 mutation. They must have finished at least 6 cycles of certain chemotherapies and surgery, not be on strong CYP3A inhibitors or inducers, and can't have had prior treatment with PARP inhibitors like olaparib.

Inclusion Criteria

I have a harmful BRCA1 or BRCA2 gene mutation.

I've completed 6 or more cycles of chemotherapy with anthracyclines, taxanes, or both.

My breast cancer is invasive and not spread to other parts.

Exclusion Criteria

Known hypersensitivity to any of the excipients of study treatment

I have never been treated with a PARP inhibitor like olaparib.

I have another cancer type but it's either treated, was caught early, or happened over 5 years ago with no recurrence.

Treatment Details

Interventions

• Olaparib (PARP Inhibitor)
• Placebo (Chemotherapy)

Trial Overview The study tests Olaparib as an additional (adjuvant) therapy against a placebo in patients with specific genetic mutations after they've completed initial treatments for breast cancer. The goal is to see if Olaparib can prevent cancer from coming back.

Participant Groups

Group I: Olaparib Experimental Treatment 1 Intervention

Olaparib tablets 300mg b.i.d. p.o.

Group II: Placebo Placebo Group 1 Intervention

Placebo tablets b.i.d. p.o.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

The Breast Adjuvant Study Team

Collaborator

Trials

1

Recruited

1,800+

Breast International Group

Collaborator

Trials

34

Recruited

53,600+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

Myriad Genetic Laboratories, Inc.

Industry Sponsor

Trials

32

Recruited

14,600+

Frontier Science & Technology Research Foundation, Inc.

Industry Sponsor

Trials

8

Recruited

7,400+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet

Collaborator

Trials

1

Recruited

1,800+