Study on Olaparib as Additional Treatment for Patients with High-Risk HER2 Negative Breast Cancer with BRCA Mutations

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT02032823

Provider View

This clinical trial is testing the effectiveness of the drug Olaparib in patients with high-risk HER2 negative breast cancer who have BRCA1 or BRCA2 gene mutations. Participants must have completed surgery and chemotherapy before joining the study.

Patient Parameters

Program Overview

The study aims to find out if Olaparib, a medication, can help prevent the return of breast cancer in patients with specific genetic mutations (BRCA1/2) and high-risk HER2 negative breast cancer. Participants will have already completed surgery and chemotherapy. They will be randomly assigned to receive either Olaparib or a placebo for up to 12 months. Regular health checks and imaging tests will be conducted to monitor for any signs of cancer returning.

Description

Participants in this study will be randomly assigned to receive either the drug Olaparib or a placebo (a substance with no active drug) in a 1:1 ratio. The assignment will consider factors like hormone receptor status and previous chemotherapy treatments. Participants will take the study medication for up to 12 months.

During the first month, safety checks will occur every two weeks, then every four weeks for the next five months, and every three months for the remaining six months. After stopping the medication, a final safety check will be done 30 days later.

Participants will have regular assessments to check for cancer recurrence, including medical history reviews, physical exams, and imaging tests like mammograms or breast MRIs. These checks will happen every three months for the first two years, every six months for the next three years, and annually after that. Annual imaging tests will continue for 10 years, starting six months after joining the study.

All participants will have clinical assessments for 10 years after joining the study. After completing these assessments, they will enter a follow-up phase that lasts until about 10 years after the last participant joins the study.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-metastatic primary invasive breast cancer that is either:
    • Triple negative (ER and PgR negative, HER2 negative)
    • ER and/or PgR positive, HER2 negative
  • Have a documented BRCA1 or BRCA2 gene mutation known to be harmful.
  • Completed surgery for breast and underarm lymph nodes.
  • Completed at least 6 cycles of chemotherapy, which may include anthracyclines, taxanes, or both. Previous platinum-based treatment is allowed.
  • Have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have previously been treated with a PARP inhibitor like Olaparib or have allergies to the study medication.
  • Have a second primary cancer, except for:
    • Treated non-melanoma skin cancer, cervical cancer in situ, DCIS of the breast, or early-stage endometrial cancer.
    • Other cancers diagnosed at least 5 years ago, treated with no recurrence, and only one line of chemotherapy.
  • Are using certain medications that interact with the study drug, including strong or moderate CYP3A inhibitors or inducers. A washout period is required before starting the study.
  • Have evidence of metastatic breast cancer.

Locations

FACILITYZIPCITYSTATE
Research Site99508AnchorageAlabama
Research Site99508AnchorageAlaska
Research Site85234GilbertArizona
Research SiteFort SmithArkansas
Research SiteBaldwin ParkCalifornia
Research Site94704BerkeleyCalifornia
Research Site91010DuarteCalifornia
Research Site92335FontanaCalifornia
Research SiteFresnoCalifornia
Research Site94904GreenbraeCalifornia

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