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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Talzenna (talazoparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Regulator OKs Pfizer's BRCA mutation breast cancer treatment
Published date:
08/05/2020
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:
Published date:
06/20/2019
Excerpt:
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Source:
Published date:
10/16/2018
Excerpt:
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.
Test:
Source:
Title:
Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline
Published date:
04/03/2020
Excerpt:
Recommendations...For BRCA1/2 mutation carriers with metastatic human epidermal growth factor receptor 2 (HER2) –negative breast cancer, olaparib or talazoparib should be offered as an alternative to chemotherapy in the first- to third-line settings.
DOI:
10.1200/JCO.20.00299
Source:
Title:
ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer
Excerpt:
Recommendations...Patients with HER2-negative MBC and germline pathogenic or likely pathogenic variants in BRCA1 or BRCA2 should be offered treatment with a PARP inhibitor (olaparib or talazoparib) independent of HR status...
DOI:
https://doi.org/10.1016/j.annonc.2021.09.019.
Source:
Excerpt:
Biomarkers associated with FDA-approved therapies...While olaparib and talazoparib are FDA indicated in HER2-negative disease, the panel supports use in any breast cancer subtype associated with a germline BRCA1 or BRCA2 mutation.
Source:
Title:
Talazoparib Versus Chemotherapy in Patients with HER2-negative Advanced Breast Cancer and a Germline BRCA1/2 Mutation Enrolled in Asian Countries: Exploratory Subgroup Analysis of the Phase III EMBRACA Trial
Published date:
03/24/2021
Excerpt:
Patients with HER2-negative germline BRCA1/2-mutated advanced breast cancer who received prior chemotherapy were randomized 2:1 to talazoparib 1 mg/day or chemotherapy (physician's choice)….In Asian patients, median PFS was 9.0 months (95% confidence interval [CI] 3.0, 15.2) for talazoparib and 7.1 months (95% CI, 1.2, not reached) for chemotherapy (hazard ratio [HR] 0.74 [95% CI, 0.22, 2.44]). Objective response rate was numerically higher for talazoparib vs. chemotherapy.
DOI:
10.4143/crt.2020.1381
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:
Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
Excerpt:
...- gBRCA1/2 mutation(s)...
Trial ID:
More C2 evidence
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:
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:
Efficacy of Talazoparib in Asian Metastatic Breast Cancer Patients With a Homologous Recombinant Deficiency (HRD) Signature
Excerpt:
......
Trial ID:
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 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:
Less C2 evidence
Source:
Title:
LuciA-15 - A real-world prospective study of PARP inhibitors for the treatment of Latin American patients with HER-2 negative metastatic breast cancer with mutation of BRCA1/2 genes or in the Homologous Recombination Repair genes.
Published date:
12/02/2023
Excerpt:
We analyzed data of patients with HER2-ve ABC with germline and/or somatic mutation of BRCA 1 or BRCA 2 or in the Homologous Recombination Repair genes, treated with olaparib or talazoparib in daily clinical practice...The rwORR was 47.0%, and the median rwPFS1 was 7.77 months (CI95% 5.67-14.7)...
Source:
Title:
Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer
Published date:
03/23/2023
Excerpt:
Characteristics, treatment patterns, and clinical outcomes of real-world US patients with gBRCAm HER2-negative LA/mBC treated with talazoparib monotherapy...median progression-free survival was 8.7 months (95% CI, 8.0-9.9), the median time from initiation to chemotherapy was 12.2 months (95% CI, 10.5-20.1), and the overall response rate was 63.1%.
DOI:
https://doi.org/10.1093/oncolo/oyad021
Source:
Title:
Efficacy and safety of talazoparib in Japanese patients with germline BRCA-mutated locally advanced or metastatic breast cancer: results of the phase 1 dose-expansion study
Published date:
07/30/2022
Excerpt:
This phase 1, open-label, multicenter study evaluated talazoparib monotherapy in Japanese patients with germline BRCA mutations and HER2-negative locally advanced or metastatic breast cancer...Confirmed ORR was 57.9% (11/19; 90% confidence interval [CI] 36.8-77.0). Stable disease was observed in 36.8% (7/19) of patients. Per investigator assessment, median PFS was 7.2 months (95% CI 4.1-not estimable) and 12-month OS rate was 84.7% (90% CI 57.5-95.1)....In Japanese patients with gBRCA mutations and locally advanced or metastatic breast cancer, talazoparib monotherapy was generally well tolerated and resulted in clinically meaningful ORRs.
DOI:
10.1007/s12282-022-01390-w
Trial ID:
Source:
Title:
Neoadjuvant talazoparib in patients with germline BRCA1/2 (gBRCA1/2) mutation-positive, early HER2-negative breast cancer (BC): Results of a phase 2 study.
Published date:
05/28/2021
Excerpt:
This phase 2, non-randomized, single-arm, open-label study (NCT03499353) evaluated the efficacy and safety of TALA in the neoadjuvant setting for pts with early gBRCA1/2-mutated HER2− BC....TALA monotherapy in the neoadjuvant setting was active and showed pCR rates comparable to those observed with combination anthracycline and taxane-based chemotherapy regimens...
DOI:
10.1200/JCO.2021.39.15_suppl.505
Source:
Title:
Neoadjuvant talazoparib (TALA) in patients (pts) with germline BRCA1/2 (gBRCA1/2) mutation-positive, early HER2-negative breast cancer (BC): Exploration of tumor BRCA mutational status and zygosity and overall mutational landscape in a phase 2 study.
Published date:
05/19/2021
Excerpt:
The biomarker analysis population was all pts treated with TALA for whom biomarker results are available...Of 52 evaluable tumor samples from 61 treated pts, 39 (75%) and 13 (25%) pts exhibited BRCA1 and BRCA2 mutations, respectively...Tumor BRCA mutations were evident in nearly all pts in the biomarker analysis population...These results support the central role of BRCA mutations in tumor pathobiology in this indication.
DOI:
10.1200/JCO.2021.39.15_suppl.554
Trial ID:
Source:
Title:
Comparative efficacy, safety, and acceptability of single-agent poly (ADP-ribose) polymerase (PARP) inhibitors in BRCA-mutated HER2-negative metastatic or advanced breast cancer: a network meta-analysis
Published date:
11/30/2020
Excerpt:
To compare the efficacy, safety, and acceptability of single-agent poly (ADP-ribose) polymerase (PARP) inhibitors for patients with BRCA-mutated HER2-negative metastatic or advanced breast cancer....Compared with talazoparib, olaparib was not associated with improved PFS (HR = 1.08, 95% CrI = 0.34-3.45) or OS (HR = 1.18, 95% CrI = 0.61-2.31). Compared with talazoparib, olaparib was associated with non-significantly improved ORR (OR = 0.83, 95% CrI = 0.05-12.64).
DOI:
10.18632/aging.202152
Source:
Title:
PARP Inhibitors in the Treatment of Early Breast Cancer: The Step Beyond?
Published date:
05/27/2020
Excerpt:
...neoadjuvant talazoparib, administered as a single-agent in patients with HER2-negative breast cancer and germline BRCA1/2 mutation, achieved an impressive pathological complete response rate of nearly 50%.
DOI:
10.3390/cancers12061378
Source:
Title:
Neoadjuvant Talazoparib for Patients With Operable Breast Cancer With a Germline BRCA Pathogenic Variant
Excerpt:
16 patients were gBRCA1 positive and 4 patients were gBRCA2 positive... RCB-0 (pathologic complete response) rate was 53% and RCB-0/I was 63%.
DOI:
10.1200/JCO.19.01304
