Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors
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- STATUS
- Recruiting
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- End date
- Dec 8, 2023
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- participants needed
- 40
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- sponsor
- Melinda Telli
Summary
The aim of this single-arm phase 2 clinical trial is to evaluate the anti-cancer activity of Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific genetic or tumor genomic alterations. Patients with either triple-negative or HER2-negative breast cancer are eligible.
Description
Talazoparib (BMN 673) is a novel, dual-mechanism PARP inhibitor that potently inhibits the PARP enzyme and effectively traps PARP on DNA. Talazoparib has shown promising single-agent anti-tumor efficacy in several BRCA1/2 mutation-associated advanced cancers. The efficacy of PARP inhibition in BRCA1/2 wild-type TNBC with homologous recombination (HR) defects and in breast tumors with mutations in other non-BRCA1/2 HR pathway genes is currently unknown.
This phase 2 trial explores the activity of single agent talazoparib in BRCA1/2 wild-type BC patients using an optimal Simon two-stage design. Eligible subjects will be assigned to one of two parallel cohorts: 1) Cohort A: Subjects (n=29) with advanced TNBC with underlying HR defects as assessed by the HRD assay and, 2) Cohort B: Subjects (n=29) with advanced HER2-negative BC with a somatic or germline mutation in a non-BRCA1/2 HR pathway gene. Gene mutations of interest are: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes (FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL).
Details
| Condition | Primary Immunodeficiency, Near-Sighted Corrective Surgery, Breast Cancer, Triple Negative Breast Cancer, Injection Port, Chronic Diarrhea, Skin Wounds, Recurrent Respiratory Papillomatosis, Diet and Nutrition, Peripheral Arterial Occlusive Disease, Metastatic Triple-Negative Breast Cancer, Vaginal Atrophy, Breast Cancer - HER2 Positive, Pediatric Health, Brain Function, HER2/Neu Negative, Chronic Shoulder Pain, Anal Dysplasia, Advanced Breast Cancer, Adverse Effects, Drugs, Razor Bumps (Pseudofolliculitis Barbae) |
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| Treatment | Talazoparib Tosylate |
| Clinical Study Identifier | NCT02401347 |
| Sponsor | Melinda Telli |
| Last Modified on | 8 September 2021 |
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