Breast Cancer
Conditions
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
Clinical outcomes
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | 10 years | The primary end points were the cumulative incidence of pregnancy and disease-free survival. |
| Cumulative Incidence of Pregnancy After Breast Cancer | 10 years | The primary end points were the cumulative incidence of pregnancy and disease-free survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cancer-Specific Survival | 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. |
| Overall Survival | 10 years | An 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
| Arm | Count |
|---|---|
| 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 |
| Total | 4,732 |
Baseline characteristics
| Characteristic | Pregnant Cohort | Non-pregnant Cohort | Total |
|---|---|---|---|
| Age, Continuous | 30 years | 35 years | 35 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 659 Participants | 4073 Participants | 4732 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 39 / 659 | 570 / 4,073 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Cohort | Cumulative Incidence of Pregnancy After Breast Cancer | 22 Percentage (Cumulative incidence at 10y) |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Cohort | Disease-free Survival | 5.44 DFS events/100*person-year |
| Non-pregnant Cohort | Disease-free Survival | 5.45 DFS events/100*person-year |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Cohort | Breast Cancer-Specific Survival | 35 Participants |
| Non-pregnant Cohort | Breast Cancer-Specific Survival | 523 Participants |
Overall Survival
An overall survival event was defined as death due to any cause.
Time frame: 10 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Cohort | Overall Survival | 39 Participants |
| Non-pregnant Cohort | Overall Survival | 570 Participants |