Multiple institute collecting the data of patients who diagnose with BRCA (BReast CAncer gene) positive breast cancer during pregnancy which can be used to estimate the chance of recovery and recurring from this type of cancer patients.
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/08/044727
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
-Diagnosis of invasive breast cancer between January 2000 and December 2020;
-Breast cancer diagnosis at the age of � 40 years;
-Known presence of germline BRCA pathogenic variant.
Exclusion Criteria
-Known BRCA mutation with no diagnosis of invasive breast cancer;
-Diagnosis of ovarian cancer or other malignancies with no history of invasive breast cancer;
-Diagnosis of hereditary or familiar invasive breast cancer without BRCA mutation or with BRCA genes not tested;
-Diagnosis of invasive breast cancer with germline BRCA variants of unknown significance.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To evaluate the prognostic impact of pregnancy following breast cancer diagnosis in BRCA mutated patients. The following survival endpoints will be considered: disease-free survival (DFS, as primary endpoint), breast cancer specific survival (BCSS, as secondary endpoint) and overall survival (OS, as secondary endpoint). <br/ ><br>- To evaluate the rate of pregnancy following breast cancer diagnosis in BRCA mutated patients. <br/ ><br>Timepoint: 1 Year
- Secondary Outcome Measures
Name Time Method - To evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated patients. <br/ ><br>- To evaluate the safety of ART procedures following breast cancer diagnosis in BRCA mutated patients. <br/ ><br>- To evaluate the impact of anticancer therapies on patients� ovarian function, in terms of incidence of treatment-induced POF and age at menopause. <br/ ><br>- To describe baseline, tumor and treatment characteristics as well as patterns of care including access to risk-reducing surgeries in BRCA mutated patients. <br/ ><br>- To evaluate the prognostic impact of baseline, tumor and treatment characteristics as well as of risk-reducing surgeries in BRCA mutated patients. <br/ ><br>- To evaluate tumor infiltrating lymphocytes (TILs) in BRCA mutated patients. <br/ ><br>Timepoint: 1 Year