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Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03673306
Enrollment
4732
Registered
2018-09-17
Start date
2017-01-16
Completion date
2023-12-31
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, BRCA, Young, Survivorship

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.

Interventions

OTHERClinical outcomes

Clinical outcomes

Sponsors

Jules Bordet Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Disease-free Survival10 yearsThe primary end points were the cumulative incidence of pregnancy and disease-free survival.
Cumulative Incidence of Pregnancy After Breast Cancer10 yearsThe primary end points were the cumulative incidence of pregnancy and disease-free survival.

Secondary

MeasureTime frameDescription
Breast Cancer-Specific Survival10 yearsA 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 Survival10 yearsAn overall survival event was defined as death due to any cause.

Countries

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, France, Georgia, Germany, India, Israel, Italy, Lebanon, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, United States

Participant flow

Pre-assignment details

Subjects should meet all eligibility criteria and have available information on pregnancy status before assignment to groups

Participants by arm

ArmCount
Pregnant Cohort
Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes
659
Non-pregnant Cohort
Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes
4,073
Total4,732

Baseline characteristics

CharacteristicPregnant CohortNon-pregnant CohortTotal
Age, Continuous30 years35 years35 years
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
659 Participants4073 Participants4732 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
39 / 659570 / 4,073
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Cumulative Incidence of Pregnancy After Breast Cancer

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

Time frame: 10 years

ArmMeasureValue (NUMBER)
Pregnant CohortCumulative Incidence of Pregnancy After Breast Cancer22 Percentage (Cumulative incidence at 10y)
Primary

Disease-free Survival

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

Time frame: 10 years

Population: A disease-free survival event was defined as the occurrence of 1 of the following invasive events: locoregional recurrence, distant metastases, new contralateral or ipsilateral invasive breast cancer, second primary malignancy, or death due to any cause.

ArmMeasureValue (NUMBER)
Pregnant CohortDisease-free Survival5.44 DFS events/100*person-year
Non-pregnant CohortDisease-free Survival5.45 DFS events/100*person-year
Secondary

Breast Cancer-Specific Survival

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.

Time frame: 10 years

Population: Breast cancer-specific survival

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pregnant CohortBreast Cancer-Specific Survival35 Participants
Non-pregnant CohortBreast Cancer-Specific Survival523 Participants
Secondary

Overall Survival

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

Time frame: 10 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pregnant CohortOverall Survival39 Participants
Non-pregnant CohortOverall Survival570 Participants

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026