Trial Outcomes & Findings for Safety of Pregnancy in BRCA Mutated Breast Cancer Patients (NCT NCT03673306)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

4732 participants

Primary outcome timeframe

10 years

Results posted on

2024-12-13

Participant Flow

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

Participant milestones

Participant milestones
Measure	Pregnant Cohort Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes	Non-pregnant Cohort Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes
Overall Study STARTED	659	4073
Overall Study COMPLETED	659	4073
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant Cohort n=659 Participants Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes	Non-pregnant Cohort n=4073 Participants Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes	Total n=4732 Participants Total of all reporting groups
Age, Continuous	30 years n=659 Participants	35 years n=4073 Participants	35 years n=4732 Participants
Sex: Female, Male Female	659 Participants n=659 Participants	4073 Participants n=4073 Participants	4732 Participants n=4732 Participants
Sex: Female, Male Male	0 Participants n=659 Participants	0 Participants n=4073 Participants	0 Participants n=4732 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Pregnant Cohort n=659 Participants Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes	Non-pregnant Cohort n=4073 Participants Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes
Disease-free Survival	5.44 DFS events/100*person-year	5.45 DFS events/100*person-year

PRIMARY outcome

Timeframe: 10 years

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

Outcome measures

Outcome measures
Measure	Pregnant Cohort n=4732 Participants Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes	Non-pregnant Cohort Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes
Cumulative Incidence of Pregnancy After Breast Cancer	22 Percentage (Cumulative incidence at 10y) Interval 21.0 to 24.0	—

SECONDARY outcome

Timeframe: 10 years

Population: 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.

Outcome measures

Outcome measures
Measure	Pregnant Cohort n=659 Participants Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes	Non-pregnant Cohort n=4073 Participants Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes
Breast Cancer-Specific Survival	35 Participants	523 Participants

SECONDARY outcome

Timeframe: 10 years

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

Outcome measures

Outcome measures
Measure	Pregnant Cohort n=659 Participants Women with one or more pregnancies any time after breast cancer diagnosis Clinical outcomes: Clinical outcomes	Non-pregnant Cohort n=4073 Participants Women with no subsequent pregnancies after breast cancer diagnosis Clinical outcomes: Clinical outcomes
Overall Survival	39 Participants	570 Participants

Adverse Events

Pregnancy Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 39 deaths

No Pregnancy Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 570 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matteo Lambertini

IRCCS Ospedale Policlinico San Martino, Genoa, Italy

Phone: +39 010 555 4254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place