Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
None listed
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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). - To evaluate the rate of pregnancy following breast cancer diagnosis in BRCA mutated patients. Timepoint: 1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated patients. - To evaluate the safety of ART procedures following breast cancer diagnosis in BRCA mutated patients. - To evaluate the impact of anticancer therapies on patientsââ?¬â?¢ ovarian function, in terms of incidence of treatment-induced POF and age at menopause. - To describe baseline, tumor and treatment characteristics as well as patterns of care including access to risk-reducing surgeries in BRCA mutated patients. - To evaluate the prognostic impact of baseline, tumor and treatment characteristics as well as of risk-reducing surgeries in BRCA mutated patients. - To evaluate tumor infiltrating lymphocytes (TILs) in BRCA mutated patients. Timepoint: 1 Year | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Lebanon, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Russian Federation, Serbia, Spain, Switzerland, United Kingdom, United States of America
Contacts
Public ContactJyoti Bajpai
Tata Memorial Centre, Mumbai
Outcome results
None listed