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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Talzenna (talazoparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Regulator OKs Pfizer's BRCA mutation breast cancer treatment
Excerpt:
Pfizer Korea said that the Ministry of Food and Drug Safety has approved Talzenna, its BRCA (Breast Cancer Susceptibility Gene) mutation breast cancer targeted therapy....treatment as monotherapy for germline BRCA (gBRCA) mutations and HER2 (human epithelial cell growth factor receptor 2) negative locally advanced or metastatic breast cancer patients have previously had chemotherapy.
Source:
Title:
BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment
Excerpt:
...all patients who are eligible for the study due to a history of positive BRCA1/2 mutation must provide documented evidence of their deleterious germline mutation status, obtained in a Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory, including but...
Trial ID:
Source:
Title:
A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
Excerpt:
...- Have a deleterious germline or a somatic BRCA1 or BRCA2 mutation, or a high diagnostic HRD test score (myChoice score ≥ 42), which represents a loss of DNA repair function based on testing performed at a sponsor-approved laboratory...
Trial ID:
More C2 evidence
Source:
Title:
FUnctional selection of advanced breast cancer patients for Talazoparib treatment Using the REpair Capacity (RECAP) test: The FUTURE trial Selectie van patiënten met uitgezaaide borstkanker voor behandeling met Talazoparib met behulp van de REpair Capacity (RECAP) test: De FUTURE studie
Excerpt:
......
Trial ID:
Source:
Title:
Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes
Excerpt:
...somatic mutations or deletions in BRCA1 or BRCA2; genomic alterations in other BRCA pathway genes (subcohorts: a....
Trial ID:
Source:
Title:
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
Excerpt:
...- Patients with only a VUS (Variant of Unknown Significance), or non-functional BRCA mutation, without a deleterious somatic BRCA 1 or 2 mutation will...
Trial ID:
Source:
Title:
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Excerpt:
...- Deleterious BRCA1 or BRCA2 mutations...
Trial ID:
Source:
Title:
Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- gBRCA1/2 mutation(s)...
Trial ID:
Source:
Title:
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
Excerpt:
...PFS rate of non-BRCA1/2 or BRCA1 promoter methylated HRD tumors compared to PFS rate of BRCA1/2 mutated HRD tumors. ...
Trial ID:
Source:
Title:
BrUOG 390: Neoadjuvant Treatment With Talazoparib
Excerpt:
...Documented mutation in BRCA1 or BRCA2 by genetic or commercial somatic testing....
Trial ID:
Source:
Title:
A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors
Excerpt:
...- Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation by Myriad Genetics' BRACAnalysis CDx test....
Trial ID:
Source:
Title:
Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency
Excerpt:
...- Germline or Somatic BRCA1/2 mutation...
Trial ID:
Source:
Title:
Talazoparib Before Standard Therapy in Treating Patients With Invasive, BRCA-Mutated Breast Cancer
Excerpt:
...- Identified deleterious mutation in BRCA 1 or 2 genes (this does...
Trial ID:
Source:
Title:
Efficacy of Talazoparib in Asian Metastatic Breast Cancer Patients With a Homologous Recombinant Deficiency (HRD) Signature
Excerpt:
......
Trial ID:
Source:
Title:
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Excerpt:
...- Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor...
Trial ID:
Source:
Title:
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Excerpt:
...- Germline BRCA 1/2 Mutation Positive...
Trial ID:
Source:
Title:
Talazoparib Maintenance Therapy in Triple-negative Breast Cancer
Excerpt:
...Patients who can receive germline BRCA1/2 mutation test or patients with previously known germline BRCA1/2 mutation status....
Trial ID:
Source:
Title:
Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response
Excerpt:
...- Deleterious BRCA1 or BRCA2 mutations...
Trial ID:
Less C2 evidence
Source:
Title:
Pharmacodynamic effects of the PARP inhibitor talazoparib (MDV3800, BMN 673) in patients with BRCA-mutated advanced solid tumors
Published date:
11/27/2023
Excerpt:
The ORR was 55% with the five partial responses lasting a median of six cycles...Intra-tumoral DNA damage response and inhibition of PARP enzymatic activity were confirmed in patients with advanced solid tumors harboring BRCA1/2 mutations after 8 days of talazoparib treatment.
DOI:
10.1007/s00280-023-04600-0
Trial ID:
Source:
Title:
Talazoparib (Tala) in patients (pts) with solid tumors with BRCA1/2 mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.
Published date:
05/25/2023
Excerpt:
Tala demonstrated antitumor activity in heavily pretreated pts with advanced solid tumors with BRCA1/2 mut. Additional study is warranted to confirm the efficacy of Tala in non-breast, non-ovarian cancer pts with BRCA1/2 mut.
DOI:
10.1200/JCO.2023.41.16_suppl.3115
Trial ID:
