46 Participants Needed

Niraparib + Trastuzumab for Breast Cancer

Recruiting at 6 trial locations
EY
Erica Stringer-Reasor, MD profile photo
Overseen ByErica Stringer-Reasor, MD
Age: 18+
Sex: Female
Trial Phase: Phase 1 & 2
Sponsor: University of Alabama at Birmingham
Must be taking: Anti-HER2 therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Trastuzumab, a part of the treatment, has shown significant effectiveness in improving survival rates and reducing tumor progression in HER2-positive breast cancer when combined with chemotherapy. This suggests potential benefits when used in combination with other drugs like Niraparib.12345

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

ES

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

I can take medicine by mouth.
Signed informed consent
I have tried at least one HER2-targeted therapy for my advanced cancer without success.
See 10 more

Exclusion Criteria

I have received a high dose of doxorubicin or a similar drug.
You have been diagnosed with HIV.
I have recovered from serious side effects of my previous treatments.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive Niraparib and Trastuzumab in varying doses to determine dose-limiting toxicity

6 weeks
Every 3 weeks

Treatment Phase 2

Participants receive the determined dose of Niraparib and Trastuzumab based on Phase 1 results

Up to 100 weeks
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Every 6 weeks

Treatment Details

Interventions

  • Niraparib
  • Trastuzumab
Trial Overview The trial tests Niraparib combined with Trastuzumab in patients with metastatic HER2+ breast cancer to check safety and effectiveness. The goal is to see if this drug combo can improve survival rates while keeping side effects low compared to current treatments.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Phase 2: Niraparib 200 mg or 100 mg + Trastuzumab 6 mg/kgExperimental Treatment2 Interventions
The dosage of Niraparib in phase 2 will be determined by the response of patients in Phase 1. A dosage of Niraparib 200 mg will be given along with Trastuzumab 6 mg/kg IV unless a dose limiting toxicity occurs in Phase 1. If so, Niraparib 100 mg will be given with Trastuzumab 6 mg/kg (instead of Niraparib 200 mg).
Group II: Phase 1: Niraparib 200 mg + Trastuzumab 6 mg/kgExperimental Treatment2 Interventions
In phase 1 patients in this first arm will receive 200 mg Niraparib in combination with 6 mg/kg Trastuzumab given IV every 3 weeks.
Group III: Phase 1: Niraparib 100 mg + Trastuzumab 6 mg/kgExperimental Treatment2 Interventions
In phase 1 patients in this second arm will receive Niraparib 100 mg in combination with 6 mg/kg Trastuzumab given IV every 3 weeks.

Niraparib is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Zejula for:
  • 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
🇺🇸
Approved in United States as Zejula for:
  • 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
🇨🇦
Approved in Canada as Zejula for:
  • 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

Trials
1,677
Recruited
2,458,000+

VFoundation

Collaborator

Trials
1
Recruited
50+

The V Foundation

Collaborator

Trials
10
Recruited
320+

Breast Cancer Research Foundation of Alabama

Collaborator

Trials
2
Recruited
70+

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials
68
Recruited
220,000+

Translational Breast Cancer Research Consortium

Collaborator

Trials
27
Recruited
3,100+

Tesaro, Inc.

Industry Sponsor

Trials
57
Recruited
10,600+

Findings from Research

Trastuzumab (Herceptin) is a humanized monoclonal antibody that effectively targets the HER2/neu receptor, showing significant antitumor activity in patients with HER2/neu-amplified metastatic breast cancer based on multiple clinical trials.
When used in combination with chemotherapy, trastuzumab enhances treatment outcomes, improving time to progression, response rates, and overall survival, marking it as a pioneering example of targeted therapy in breast cancer management.
Overview of treatment results with trastuzumab (Herceptin) in metastatic breast cancer.Hortobagyi, GN.[2016]
Trastuzumab (Herceptin) has demonstrated significant antitumor activity in patients with HER-2-positive metastatic breast cancer, improving response and survival rates when combined with first-line chemotherapy.
Recent clinical trials have focused on new chemotherapy approaches for node-positive breast cancer, laying the groundwork for ongoing studies that incorporate trastuzumab into treatment regimens.
Ongoing and planned adjuvant trials with trastuzumab.Perez, EA., Hortobagyi, GN.[2015]
HER2-positive breast cancer, which historically had a poor prognosis, can now be effectively treated with a variety of anti-HER2 therapies, significantly improving patient survival rates.
Newly developed treatments, including trastuzumab deruxtecan and trastuzumab emtansine, along with ongoing clinical trials, are expanding options for patients with advanced HER2-positive breast cancer, raising important questions about the best treatment sequences and combinations.
Anti-HER2 Drugs for the Treatment of Advanced HER2 Positive Breast Cancer.Stanowicka-Grada, M., Senkus, E.[2023]

References

Overview of treatment results with trastuzumab (Herceptin) in metastatic breast cancer. [2016]
Ongoing and planned adjuvant trials with trastuzumab. [2015]
Anti-HER2 Drugs for the Treatment of Advanced HER2 Positive Breast Cancer. [2023]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Targeting the human epidermal growth factor receptor 2 (HER2) in the treatment of breast cancer: recent advances and future directions. [2019]
High efficacy of pre-operative trastuzumab combined with paclitaxel following doxorubicin & cyclophosphamide in operable breast cancer. [2015]
Cardiac Safety of Dual Anti-HER2 Therapy in the Neoadjuvant Setting for Treatment of HER2-Positive Breast Cancer. [2018]
4-years results of weekly trastuzumab and paclitaxel in the treatment of women with HER2/neu overexpressing advanced breast cancer: single institution prospective study. [2015]
Buparlisib in breast cancer. [2021]
Trastuzumab plus pertuzumab in combination with chemotherapy in metastatic HER2-positive breast cancer: a retrospective single-armed cohort study in China. [2022]
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. [2019]
Trastuzumab retreatment after relapse on adjuvant trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer: final results of the Retreatment after HErceptin Adjuvant trial. [2022]
Trastuzumab. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Trastuzumab in combination with chemotherapy for the treatment of metastatic breast cancer. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Maximizing clinical benefit with trastuzumab. [2019]
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