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Completed

NCT Number: NCT03673306

Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Aleman, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical outcomes

Other

Clinical outcomes

Primary outcomes

  1. Disease-free Survival

    Time frame: 10 years

    The primary end points were the cumulative incidence of pregnancy and disease-free survival.

  2. Cumulative Incidence of Pregnancy After Breast Cancer

    Time frame: 10 years

    The primary end points were the cumulative incidence of pregnancy and disease-free survival.

Secondary outcomes

  1. Breast Cancer-Specific Survival

    Time frame: 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.

  2. Overall Survival

    Time frame: 10 years

    An overall survival event was defined as death due to any cause.

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2018
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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