Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

Completed

• Conditions: Breast Cancer

• Registration Number: NCT03673306
• Lead Sponsor: Jules Bordet Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-16
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Results First Submitted: 2023-06-20
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Status Verified: 2024-02
• Results First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Results First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4732

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	10 years	The primary end points were the cumulative incidence of pregnancy and disease-free survival.
Cumulative Incidence of Pregnancy After Breast Cancer	10 years	The primary end points were the cumulative incidence of pregnancy and disease-free survival.

Secondary Outcome Measures

Name	Time	Method
Breast Cancer-Specific Survival	10 years	A breast cancer-specific survival event was defined as death due to breast cancer, and patients who died for reasons other than breast cancer were censored at the date of death.
Overall Survival	10 years	An overall survival event was defined as death due to any cause.

Trial Locations

Locations (81)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Michigan State University; 🇺🇸 Lansing, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of North Carolina - Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States

Cleveland Clinic Taussig Cancer Institute; 🇺🇸 Cleveland, Ohio, United States

Lifespan Cancer Institute; 🇺🇸 Providence, Rhode Island, United States

Hospital Aleman; 🇦🇷 Buenos Aires, Argentina

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Instituto Alexander Fleming; 🇦🇷 Buenos Aires, Argentina

kConFab, Follow-up Project; 🇦🇺 Melbourne, Victoria, Australia

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