N/A
Completed N=4,732
Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
Source: ClinicalTrials.gov NCT03673306 ↗Enrolled (actual)
4,732
Serious AEs
—
Results posted
Dec 2024
Primary outcomePrimary: Disease-free Survival — 5.44; 5.45 DFS events/100*person-year
Summary
The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival |
5.44; 5.45 | — |
| PRIMARY Cumulative Incidence of Pregnancy After Breast Cancer |
22 | — |
| SECONDARY Breast Cancer-Specific Survival |
35; 523 | — |
| SECONDARY Overall Survival |
39; 570 | — |
Eligibility 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 mutation.
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.
Data sourced from ClinicalTrials.gov (NCT03673306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.