๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-31

Olaparib In Metastatic Breast Cancer (NCT03344965)

A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients With Germline or Somatic Mutations in DNA Repair Genes (Olaparib Expanded)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Beth Israel Deaconess Medical Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This research study is for patients with metastatic breast cancer. * Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. * This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. * Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments. Information from those other research studies suggests that this drug may help to treat metastatic breast cancer. * This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been inherited from a parent, or may have developed only in the tumor. * This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor, but not inherited.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (20 Sites)

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • University of California, San Francisco โ€” San Francisco, California
  • University of Chicago โ€” Chicago, Illinois
  • Indiana University โ€” Indianapolis, Indiana
  • Johns Hopkins University โ€” Baltimore, Maryland
  • Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts
  • Brigham and Women's Hospital โ€” Boston, Massachusetts
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • Memorial Sloan Kettering Cancer Center Basking Ridge โ€” Basking Ridge, New Jersey
  • Memorial Sloan Kettering Cancer Center Monmouth โ€” Middletown, New Jersey
  • Memorial Sloan Kettering Cancer Center Bergen โ€” Montvale, New Jersey
  • Memorial Sloan Kettering Cancer Center Commack โ€” Commack, New York
  • Memorial Sloan Kettering Cancer Center Westchester โ€” East White Plains, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center Nassau โ€” Uniondale, New York
  • Duke University โ€” Durham, North Carolina
  • UPMC Hillman Cancer Center - Erie โ€” Erie, Pennsylvania
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • University of Pittsburgh โ€” Pittsburgh, Pennsylvania
  • University of Washington Fred Hutchinson Cancer Care โ€” Seattle, Washington

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—