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Association details:
| Biomarker: | BRCA2 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:
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:
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:
A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
Excerpt:
...- Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation -...
Trial ID:
Source:
Title:
Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes
Excerpt:
...Molecular markers that may predict clinical benefit`Pharmacodynamic markers in blood and plasma that may predict outcome`BRCA1/2 alterations in archival tissue`BRCA1/2 alterations in pretreatment biopsies`Genomic alterations in tumor deoxyribonucleic acid`Genomic alterations in circulating free deoxyribonucleic acid`Change in marker levels`Baseline proteomic signature and pharmacodynamic response by reverse phase protein array`Archival immunohistochemistry staining`Baseline biopsy immunohistochemistry staining...
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:
Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m
Excerpt:
...- BRCA1, BRCA2, BRCA1 and BRCA2 germline mutation, or BRCA germline mutation...
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:
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:
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:
...- Recurrent, and/or metastatic germline breast cancer (BRCA) 1/2 mutation-associated ovarian cancer, with progression on a poly (ADP-ribose) polymerase (PARP) inhibitor monotherapy after attaining a response to that PARPi (complete response (CR), partial response (PR), or stable disease (SD) greater than or equal to 4mo)...
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:
