Olaparib for Metastatic Breast Cancer

(OlympiAD Trial)

Not currently recruiting at 187 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must not be taking: PARP inhibitors

Disqualifiers: HER2 positive, HIV, brain metastases, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of olaparib (Lynparza) compared to standard chemotherapy for people with metastatic breast cancer. It targets those with specific BRCA1 or BRCA2 gene mutations, which can influence cancer development. Participants will receive either olaparib or a chemotherapy treatment selected by their doctor. Ideal candidates have previously undergone treatment with specific cancer drugs, have breast cancer that has spread, and possess a BRCA gene mutation. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that olaparib reduced the risk of cancer worsening or spreading by 42% compared to certain chemotherapy options. This finding suggests that olaparib might be more effective for some patients. The OlympiAD trial examined olaparib's safety and found it generally well-tolerated by patients with a specific type of breast cancer, indicating that most did not experience severe side effects.

The chemotherapy options in this trial, such as capecitabine, vinorelbine, and eribulin, are already part of standard treatments. This indicates a known safety profile, meaning doctors are familiar with their side effects and management.

Overall, evidence suggests that olaparib is well-tolerated and may offer a safer option for many people. However, discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Olaparib is unique because it specifically targets cancer cells with certain genetic mutations, making it different from traditional chemotherapy treatments. While most treatments for metastatic breast cancer involve broad-acting chemotherapy that affects both healthy and cancerous cells, Olaparib is a PARP inhibitor. This means it works by blocking a protein that cancer cells need to repair damaged DNA, thereby selectively attacking cancer cells while sparing normal ones. Researchers are excited about Olaparib because it offers a more targeted approach, potentially leading to fewer side effects and better outcomes for patients with specific genetic profiles.

What evidence suggests that this trial's treatments could be effective for metastatic breast cancer?

Research has shown that olaparib, one of the treatments studied in this trial, effectively treats metastatic breast cancer in patients with specific genetic mutations (gBRCA 1/2). One study found that olaparib reduced the risk of cancer worsening or causing death by 42% compared to some chemotherapy treatments. It also helped patients live longer without their cancer progressing. In another study, 9% of patients experienced a complete response, meaning no signs of cancer were found, compared to only 1.5% with standard treatments. These findings suggest that olaparib is a promising option for this type of breast cancer. Participants in this trial will receive either olaparib or a chemotherapy regimen chosen by their physician. ^{2 3 6 7 8}

Who Is on the Research Team?

Mark Robson, MD

Principal Investigator

Memorial Sloan-Kettering Cancer Center, New York

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. lynparza.com lynparza.com/breast-cancer/results/metastatic-breast-cancer.html

Metastatic Breast Cancer - Clinical Study Results of ... LYNPARZA lowered the risk of cancer growing or spreading, or death by 42% compared with certain chemotherapies. 52% of people who took LYNPARZA and 23% of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6503629/

OlympiAD final overall survival and tolerability results In the OlympiAD study, olaparib was shown to improve progression-free survival compared with chemotherapy treatment of physician's choice (TPC) in patients ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39544591/

Real-World Clinical Outcomes of Treatment With Olaparib ... Our data showed that olaparib is effective in the real world. The incidence of neutropenia seemed higher in Japanese patients. Keywords: brca ...

4. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2024/lynparza-demonstrated-clinically-meaningful-prolonged-survival-benefit-in-early-breast-cancer-in-olympia-phase-iii-trial.html

LYNPARZA® (olaparib) demonstrated clinically meaningful ... LYNPARZA reduced the risk of invasive breast cancer recurrence, second cancers or death by 35% (HR 0.65; 95% CI; 0.53-0.78) and reduced the risk ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1706450

Olaparib for Metastatic Breast Cancer in Patients with a ... A complete response was seen in 9.0% of the patients who had measurable disease in the olaparib group and in 1.5% in the standard-therapy group.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10948524/

Clinical effectiveness and safety of olaparib in BRCA-mutated ... The interim analysis of the phase IIIb LUCY trial demonstrated the clinical effectiveness of olaparib in patients with germline BRCA-mutated ...

7. lynparzahcp.com lynparzahcp.com/breast-cancer/safety-tolerability/olympiad.html

gBRCAm, HER2-Negative, Metastatic Breast Cancer Learn about the safety and tolerability for LYNPARZA® (olaparib) in the OlympiAD trial for patients with gBRCAm, HER2-negative, metastatic breast cancer.

8. bigagainstbreastcancer.org bigagainstbreastcancer.org/new-data-confirms-olaparibs-survival-benefits-in-early-breast-cancer/

new data confirms olaparib's survival benefits in early ... Survival rates at six years were 87.5% for olaparib patients versus 83.2% for those on placebo. 35% Reduced risk of events: Olaparib reduced the ...