Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

Overview

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.

Full Title of Study: “A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 2019

Interventions

  • Other: Clinical outcomes
    • Clinical outcomes

Arms, Groups and Cohorts

  • Pregnant cohort
    • Women with one or more pregnancies any time after breast cancer diagnosis
  • Non-pregnant cohort
    • Women with no subsequent pregnancies after breast cancer diagnosis

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with a pregnancy following breast cancer diagnosis
    • Time Frame: 10 years
    • The incidence of pregnancy following breast cancer diagnosis will be computed as the ratio between the number of breast cancer survivors in the pregnant cohort and the total number of eligible patients included in the study.
  • Disease-free survival and overall survival
    • Time Frame: 10 years
    • To evaluate the prognostic impact of pregnancy following breast cancer diagnosis in BRCA mutated survivors, two survival endpoints will be compared between patients with and without a pregnancy following breast cancer diagnosis: disease-free survival and overall survival. Disease-free survival event is defined by the occurrence of one of the following invasive events: local recurrence, distant metastases, contralateral or ipsilateral breast tumor, second primary malignancy, or death from any cause. Overall survival event is defined as death from any cause.

Secondary Measures

  • Number of pregnancies resulting in live birth and number of children born
    • Time Frame: 10 years
    • Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors
  • Number of pregnancies resulting in induced and spontaneous abortion
    • Time Frame: 10 years
    • Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors
  • Number of pregnancies resulting in pregnancy complications (if any)
    • Time Frame: 10 years
    • Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors
  • Number of pregnancies resulting in fetal complication and/or congenital malformations (if any)
    • Time Frame: 10 years
    • Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors
  • Number of pregnancies resulting in obstetrical complications (if any)
    • Time Frame: 10 years
    • Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of invasive breast cancer between January 2000 and December 2012;
  • 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.

Gender Eligibility: Female

Women only

Minimum Age: 18 Years

Maximum Age: 40 Years

Investigator Details

  • Lead Sponsor
    • Jules Bordet Institute
  • Provider of Information About this Clinical Study
    • Sponsor

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