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Research & Clinical Trials > Study Search Tool > Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer. (OlympiA)

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Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer. (OlympiA)

This study is open to:

Patient can participate if they have:

  • stage 2 or 3 invasive breast cancer.
  • triple negative or ER/PR positive, Her2neu negative breast cancer.
  • a documented BRCA1 or BRCA2 mutation. Potential participants who have not had genetic testing can undergo genetic testing before enrolling. 
  • completed adequate breast and axilla surgery.
  • completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.

You can view a summary of eligibility and exclusion criteria.

This study is not open to:

Patients are excluded if they: 

  • have had any previous treatment with a PARP inhibitor.
  • have had a second cancer diagnosis, with the following exceptions:
    • adequately treated non-melanoma skin cancer
    • curatively treated in situ cancer of the cervix 
    • Ductal Carcinoma in situ (DCIS) of the breast 
    • stage 1 grade 1 endometrial carcinoma
    • other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5 years prior to enrolling and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
    • evidence of metastatic breast cancer

You can view a summary of eligibility and exclusion criteria.

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer. (OlympiA)

OlympiA - Olaparib Adjuvant Therapy for BRCA-related Breast Cancer

Clinicaltrials.gov identifier:
NCT02032823

Treatment:
Breast

Study Contact Information

The study is open in  1152 locations globally, including sites in most states. For information regarding US sites contact NRG Oncology Clinical Coordinating Department 1-800-477-7227.

About the Study

The OlympiA trial is the first major study to test the PARP inhibitor olaparib (Lynparza) for people with BRCA mutation-associated breast cancer in the adjuvant setting (after surgery) for people with earlier-stage (stage 2 or stage 3) cancers. OlympiA is a phase III clinical trial looking at the safety and effectiveness of olaparib for women with stage 2 or 3 breast cancer with a BRCA mutation after they have completed standard therapy.

Type of Study

This is a randomized, double-blind, 2-arm, placebo-controlled study. 

  • This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither you nor the research doctor will choose what group you will be in. You will have an equal chance of being placed in either group. 

  • This is a double-blind study. This means that neither the participants nor their doctors will know whether they are receiving olaparib or the placebo while participating in the study.

  • The study has two arms. This means that patients in the study are placed in one of two different groups.

  • This is a placebo-controlled study. Placebos are harmless sugar pills. Placebos are only used in research in situations where there is no standard treatment. Patients begin the study after they complete standard treatment. 

What the Study Entails

  • The study is open to patients who have been diagnosed with stage 2 or stage 3 breast cancer who are considered curable but at high risk for recurrence.
  • OlympiA participants are required to complete all standard treatments, including chemotherapy and surgery and, if needed, radiation therapy. Patients can receive either neoadjuvant or adjuvant chemotherapy.
  • After chemotherapy has been completed, participants who enroll in OlympiA will be randomized to receive either olaparib or a placebo for a year after standard treatment. Because the study begins after chemotherapy ends—a time when patients do not typically receive additional therapy—comparing Lynparza to a placebo is appropriate.
  • Patients will be followed closely for disease recurrence and new cancers for approximately 10 years to determine the efficacy of adjuvant treatment with olaparib on invasive disease-free survival.

Study Lead Investigator

  • Principal Investigator: Andrew Tutt, Doctor of Medicine Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK
  • Principal Investigator: Bella Kaufman, Sheba Medical Center, 1 Tel Hashomer, Israel
  • Principal Investigator: Judy Garber, Doctor of Medicine Harvard Medical School, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Boston; MA 
  • Principal Investigator: Charles Geyer, Doctor of Medicine Virginia Commonwealth University Massey Cancer Center, Richmond, VA 

Study Sites

The study is open in  1152 locations globally, including sites in most states. 

Contact:  

  • For information regarding US sites contact NRG Oncology Clinical Coordinating Department 1-800-477-7227
  • Contact AstraZeneca at: 1-877-240-9479 or email information.center@astrazeneca.com 

Watch this webinar for more information about PARP inhibitors and the OympiA study. 

FORCE:Facing Our Risk of Cancer Empowered