Retrospective observational study of safety and efficacy of Talazoparib in BRCA1/2 or PALB2 mutation breast cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to find the PFS of patients treated with talazoparib as a
研究概览
简要总结
The study is a single arm, retrospective cohort study of patients with a deleterious, suspected
deleterious, or pathogenic germline BRCA1/2 or PALB2 mutation breast cancer.
Treatment pattern with Talazoparib, discontinuation due to disease progression, unacceptable toxicity,
consent withdrawal or physician discretion will be studied.
Patients who were discontinued from study medication for any reason other than radiographic disease
progression as determined by the IRF or initiation of a new antineoplastic therapy will be followed to
radiographic progression by imaging assessments (eg, computed tomography [CT] scans).
Patients with altleast one available medical record on EMR will be included in the analysis.
Progression free survival, overall survival and toxicity will be studied.
Response will be assessed post evaluation of age, menopausal status, baseline tumor characteristics,
ECOG, metastatic sites, comorbidities, previous anticancer treatment like surgery, radiation,
chemotherapy lines received, ET lines, other ongoing treatments for comorbidities, visceral, non
visceral disease.
Data will be collected through EMR from all available records and reports such as blood
investigations, radiological reports, physician notes and histopathological reports to assess the
primary objective of the trial. Response will be calculated from the day of starting of Talazoparib to
date of last dose. Toxicity will be graded as per CTCAE V 4.03. Adverse events and tolerability will
be assessed along with time to recover from the toxicity. Dose reductions and interruptions will be
studied.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients who were included in Talazoparib patient access program. To be enrolled in the program, patients were required to have fulfilling the following criteria.
- •Patients with age 18 years or older with any gender and diagnosed with a deleterious, suspected deleterious, or pathogenic germline BRCA1/2 or PALB2 mutation breast will be included in the analysis.
- •At least 1 EMR record of followup, post initiation of study treatment.
排除标准
- •No available EMR records.
结局指标
主要结局
The primary objective of the study is to find the PFS of patients treated with talazoparib as a
时间窗: 1 year
monotherapy.
时间窗: 1 year
次要结局
- The secondary objectives of the study are to evaluate the following:(1. Objective response rate (ORR))
研究者
Dr Sudeep Gupta
Tata Memorial Center