Olaparib for Metastatic Breast Cancer

(OlympiAD Trial)

Recruiting at 142 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 24 weeks

302 Participants Needed

Trial Summary

What is the purpose of this trial?

This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.

Research Team

Mark Robson, MD

Principal Investigator

Memorial Sloan-Kettering Cancer Center, New York

Eligibility Criteria

This trial is for metastatic breast cancer patients with a harmful BRCA1/2 gene mutation. They must have had prior treatments including an anthracycline and a taxane, possibly platinum, but not progressed on it. ER/PR positive patients should have tried endocrine therapy without success or been deemed unsuitable for it. No more than two chemotherapy lines for metastatic cancer are allowed, and they can't have untreated brain metastases or certain other cancers unless cured over 5 years ago.

Inclusion Criteria

I have a harmful BRCA1 or BRCA2 gene mutation.

My breast cancer has spread and this was confirmed through testing.

I am fully active or can carry out light work.

Exclusion Criteria

My cancer is HER2 positive.

I have brain metastases that haven't been treated or controlled.

I am HIV positive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either olaparib monotherapy or physician's choice chemotherapy (capecitabine, vinorelbine, or eribulin) for metastatic breast cancer

24 weeks

Radiological scans every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for progression-free survival and overall survival

Up to 30 months

Every 8 weeks, then every 12 weeks

Extended Follow-up

Participants are monitored for overall survival and subsequent cancer therapies

Up to 64 months

Every 3 months

Treatment Details

Interventions

• Olaparib
• Physician's choice chemotherapy

Trial Overview The study compares the effectiveness of Olaparib alone versus standard chemotherapy (capecitabine, vinorelbine, or eribulin) chosen by the physician in treating metastatic breast cancer with gBRCA mutations. It's an open-label phase III trial where participants are randomly assigned to either treatment group.

Participant Groups

Group I: Olaparib Experimental Treatment 1 Intervention

Olaparib tablet 300mg bd po

Group II: Physician's choice chemotherapy Active Control 1 Intervention

Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21

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

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

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

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

Myriad Genetic Laboratories, Inc.

Industry Sponsor

Trials

32

Recruited

14,600+