Talazoparib for Breast Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Massachusetts General Hospital
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing talazoparib, a drug that may help treat breast cancer that has spread and has specific genetic mutations (BRCA 1 or BRCA 2). Talazoparib works by stopping proteins that repair DNA, making it harder for cancer cells to survive. The goal is to see if this drug can reduce tumor size and slow down cancer growth in these patients. Talazoparib is a new treatment recently approved for use in patients with metastatic breast cancer with germline BRCA mutations.
Do I need to stop my current medications to join the trial?
The trial requires that you stop any anti-cancer therapy, including chemotherapy, hormone therapy, immunotherapy, or other investigational therapies, before joining. You should not be on strong P-glycoprotein inhibitors either. If you are taking any of these, you will need to stop them to participate.
What data supports the effectiveness of the drug Talazoparib for breast cancer?
Talazoparib has shown effectiveness in patients with advanced or metastatic HER2-negative breast cancer and BRCA mutations, providing better outcomes than chemotherapy, such as complete responses and improved quality of life.
12345Is Talazoparib safe for humans?
Talazoparib has shown promising safety in patients with advanced breast cancer, as reported in the ABRAZO phase 2 trial. It is approved by the FDA and EMA for certain types of breast cancer, indicating it has undergone safety evaluations.
12467How is the drug Talazoparib different from other breast cancer treatments?
Talazoparib is unique because it is an oral drug that specifically targets and inhibits PARP enzymes, which are crucial for repairing DNA damage in cancer cells, particularly in patients with BRCA mutations. This makes it different from traditional chemotherapy, which does not target specific genetic mutations.
12347Eligibility Criteria
This trial is for adults with metastatic breast cancer that has a specific BRCA mutation detected in tumor DNA, not inherited. Participants must have progressed after prior treatments or be unsuitable for them, and should not be on certain drugs or have untreated brain metastases. They need functioning organs and controlled previous cancers, agree to contraception if applicable, and cannot be pregnant.Inclusion Criteria
My cancer does not have a harmful BRCA 1 or 2 mutation.
My triple negative breast cancer has worsened after at least one chemotherapy treatment.
My cancer is hormone receptor positive, HER2 negative, and has worsened despite endocrine therapy.
I am using birth control, am surgically sterile, or not having heterosexual sex for the study and 7 months after.
I do not have a BRCA 1 or 2 gene mutation.
My metastatic breast cancer has BRCA 1 or 2 mutations.
I am 18 years old or older.
I can take care of myself but might not be able to do heavy physical work.
Exclusion Criteria
I am not taking strong P-glycoprotein inhibitors.
I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.
I have an active Hepatitis B or C infection.
I am not currently on any cancer treatments.
I do not have a BRCA 1 or 2 gene mutation.
I have been diagnosed with HIV.
I have untreated brain metastases or cancer in the lining of my brain.
I have never been treated with a PARP inhibitor.
Participant Groups
The trial tests Talazoparib's effectiveness against metastatic breast cancer with somatic BRCA mutations. It examines how well patients respond to this PARP inhibitor when they've had limited or no success with other therapies including platinum-based chemotherapy.
1Treatment groups
Experimental Treatment
Group I: TalazoparibExperimental Treatment1 Intervention
-Talazoparib will be provided as capsules for oral administration daily
Talazoparib is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Talzenna for:
- Deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer
🇪🇺 Approved in European Union as Talzenna for:
- Monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vanderbilt UniversityNashville, TN
Weill Cornell MedicineNew York, NY
MD Anderson Cancer CenterHouston, TX
Emory University Winship Cancer InstituteAtlanta, GA
More Trial Locations
Loading ...
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
PfizerIndustry Sponsor
References
Talazoparib: First Global Approval. [2020]Talazoparib (TALZENNA™) is an oral inhibitor of the polyadenosine 5'-diphosphoribose polymerase (PARP) enzymes, which play a critical role in repairing DNA single-strand breaks. It has been developed by Pfizer and was recently approved in the USA for the treatment of adults with deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer (as detected by a US FDA-approved assay). A regulatory assessment for talazoparib in this patient population is underway in the EU, with talazoparib also undergoing development for use in metastatic castration-resistant prostate cancer and various solid tumours, and as neoadjuvant therapy in early triple negative breast cancer. This article summarizes the milestones in the development of talazoparib leading to its first approval for the treatment of adults with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, locally advanced or metastatic breast cancer.
Quality of life with talazoparib after platinum or multiple cytotoxic non-platinum regimens in patients with advanced breast cancer and germline BRCA1/2 mutations: patient-reported outcomes from the ABRAZO phase 2 trial. [2021]Talazoparib (1 mg/day) exhibited promising efficacy and safety in patients with advanced breast cancer during ABRAZO (NCT02034916); this study evaluated patient-reported outcomes (PROs).
Comparison between talazoparib and conventional chemotherapy in the treatment of HER2-positive breast cancer patients: A retrospective study. [2022]The benefits of talazoparib compared with conventional chemotherapy in HER2-negative advanced breast cancer (ABC) remain unclear.
Neoadjuvant Talazoparib for Patients With Operable Breast Cancer With a Germline BRCA Pathogenic Variant. [2021]Label="PURPOSE">Talazoparib has demonstrated efficacy in patients with BRCA-positive metastatic breast cancer. This study evaluated the pathologic response of talazoparib alone for 6 months in patients with a known germline BRCA pathogenic variant (gBRCA-positive) and operable breast cancer.
Talazoparib Bests Chemo for Breast Cancer. [2019]Patients with advanced or metastatic HER2-negative breast cancer and germline BRCA1/2 mutations may benefit from talazoparib, according to data from a phase III trial. Compared with chemotherapy, the investigational PARP inhibitor induced some complete responses, prolonged progression-free survival, and improved patients' overall quality of life.
Talazoparib to treat BRCA-positive breast cancer. [2019]Talazoparib tosylate (BMN-673, Talzenna; Pfizer) is an oral poly [ADP-ribose] polymerase (PARP) inhibitor (PARPi) that has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of germline BRCA-mutated locally advanced or metastatic breast cancer (BC). In preclinical and clinical studies, talazoparib exerted superior efficacy and offered a significant clinical benefit in advanced or metastatic BC patients harboring germline BRCA mutations compared with other PARPi and standard chemotherapy regimens through the concept of synthetic lethality. Thus, this review provides insight into the results of preclinical and clinical studies, highlights the current challenges of talazoparib and suggests innovative approaches to further improve its clinical efficacy and expand the use of talazoparib in advanced BC and/or triple-negative BC treatments beyond BRCA mutations.
A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). [2021]Label="PURPOSE">To assess talazoparib activity in germline BRCA1/2 mutation carriers with advanced breast cancer.