Niraparib + Trastuzumab for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) for prior chemotherapy and hormonal therapy. You must stop any concurrent anti-cancer treatments and certain immunosuppressive therapies before starting the trial.
What data supports the effectiveness of the drug combination Niraparib and Trastuzumab for breast cancer?
Is the combination of Niraparib and Trastuzumab safe for humans?
Trastuzumab has been studied for safety in breast cancer treatments, often combined with other drugs, and is generally considered safe, though it can have side effects like heart issues. Niraparib has been approved for other cancers and has shown a tolerable safety profile, but specific safety data for the combination of Niraparib and Trastuzumab in breast cancer is not available.678910
What makes the drug combination of Niraparib and Trastuzumab unique for breast cancer treatment?
The combination of Niraparib and Trastuzumab is unique because it combines a PARP inhibitor (Niraparib) with a monoclonal antibody (Trastuzumab) targeting HER2-positive breast cancer, potentially offering a novel approach by leveraging different mechanisms of action to enhance treatment efficacy.211121314
What is the purpose of this trial?
The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer. This study will evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.
Research Team
Erica Stringer-Reasor, M.D.
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
This trial is for women over 18 with aggressive HER2+ metastatic breast cancer who've already tried at least one anti-HER2 therapy. They must be able to take pills, have a heart ejection fraction of ≥50%, and not be pregnant or planning pregnancy during the study. Participants need normal organ/marrow function and measurable disease per RECIST v1.1.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive Niraparib and Trastuzumab in varying doses to determine dose-limiting toxicity
Treatment Phase 2
Participants receive the determined dose of Niraparib and Trastuzumab based on Phase 1 results
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Niraparib
- Trastuzumab
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
VFoundation
Collaborator
The V Foundation
Collaborator
Breast Cancer Research Foundation of Alabama
Collaborator
Susan G. Komen Breast Cancer Foundation
Collaborator
Translational Breast Cancer Research Consortium
Collaborator
Tesaro, Inc.
Industry Sponsor