Talazoparib in Patients with a Germline BRCA-Mutated Advanced Breast Cancer: Detailed Safety Analyses from the Phase III EMBRACA Trial.
Sara Alsterlind HurvitzAnthony GonçalvesHope S RugoKyung-Hun LeeLouis FehrenbacherLida A MinaSami DiabJoanne L BlumJayeta ChakrabartiMohamed ElmeliegyLiza DeAnnuntisEric GauthierAkos CzibereIulia Cristina TudorRuben G W QuekJennifer K LittonJohannes EttlPublished in: The oncologist (2019)
Talazoparib was generally well tolerated in patients with germline BRCA-mutated HER2-negative advanced breast cancer in the EMBRACA trial. Common toxicities with talazoparib were primarily hematologic and infrequently resulted in permanent drug discontinuation (<2% of patients discontinued talazoparib due to hematologic toxicity). Hematologic toxicities typically occurred during the first 3-4 months of treatment and were managed by dose modifications and supportive care measures. A significant efficacy benefit, improved patient-reported outcomes, lower rate of health resource utilization and a tolerable safety profile support incorporating talazoparib into routine management of germline BRCA-mutated locally advanced/metastatic breast cancer.
Keyphrases
- phase iii
- patient reported outcomes
- open label
- clinical trial
- metastatic breast cancer
- breast cancer risk
- phase ii
- healthcare
- dna repair
- locally advanced
- end stage renal disease
- double blind
- study protocol
- newly diagnosed
- placebo controlled
- squamous cell carcinoma
- public health
- chronic kidney disease
- mental health
- rectal cancer
- wild type
- phase ii study
- neoadjuvant chemotherapy
- quality improvement
- palliative care
- randomized controlled trial
- peritoneal dialysis
- radiation therapy
- lymph node
- drug induced
- health information
- health insurance
- health promotion