Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Clinical outcomes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant cohort<br>Women with one or more pregnancies any time after breast cancer diagnosis | Other: Clinical outcomes<br>* Clinical outcomes<br>|
| Non-pregnant cohort<br>Women with no subsequent pregnancies after breast cancer diagnosis | Other: Clinical outcomes<br>* Clinical outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a pregnancy following breast cancer diagnosis | 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. | 10 years | 
| Disease-free survival and overall survival | 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. | 10 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, BRCA, Young, Survivorship