Trial · NCT03673306
Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
NCT03673306, Completed, Jules Bordet Institute; results first posted 2024-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of Pregnancy in BRCA Mutated Breast Cancer Patients. Trials, record NCT03673306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03673306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Pregnancy in BRCA Mutated Breast Cancer Patients
- NCT number
- NCT03673306
- Status
- Completed
- Enrollment
- 4,732 participants, actual
- Lead sponsor
- Jules Bordet Institute
- Conditions
- Breast Cancer
- Interventions
- Clinical outcomes
- First posted
- 2018-09-17
- Last updated
- 2024-12-13
- Results first posted
- 2024-12-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival | 10 years | The primary end points were the cumulative incidence of pregnancy and disease-free survival. |
| Primary | Cumulative Incidence of Pregnancy After Breast Cancer | 10 years | The primary end points were the cumulative incidence of pregnancy and disease-free survival. |
| Secondary | 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. |
| Secondary | Overall Survival | 10 years | An overall survival event was defined as death due to any cause. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival | 10 years | 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. | DFS events/100*person-year | NUMBER |
| PRIMARY | Cumulative Incidence of Pregnancy After Breast Cancer | 10 years | Percentage (Cumulative incidence at 10y) | NUMBER | |
| SECONDARY | Breast Cancer-Specific Survival | 10 years | Breast cancer-specific survival | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | 10 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival | Pregnant Cohort | 5.44 | DFS events/100*person-year | ||
| Disease-free Survival | Non-pregnant Cohort | 5.45 | DFS events/100*person-year | ||
| Cumulative Incidence of Pregnancy After Breast Cancer | Overall Cohort | 22 | 95% Confidence Interval 21 to 24 | Percentage (Cumulative incidence at 10y) | |
| Breast Cancer-Specific Survival | Pregnant Cohort | 35 | Participants | ||
| Breast Cancer-Specific Survival | Non-pregnant Cohort | 523 | Participants | ||
| Overall Survival | Pregnant Cohort | 39 | Participants | ||
| Overall Survival | Non-pregnant Cohort | 570 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregnant Cohort | 659 | |
| Overall Study | STARTED | Non-pregnant Cohort | 4,073 | |
| Overall Study | COMPLETED | Pregnant Cohort | 659 | |
| Overall Study | COMPLETED | Non-pregnant Cohort | 4,073 | |
| Overall Study | NOT COMPLETED | Pregnant Cohort | 0 | |
| Overall Study | NOT COMPLETED | Non-pregnant Cohort | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregnancy Cohort | 39 | 659 |
| Total, all-cause mortality | No Pregnancy Cohort | 570 | 4,073 |
| Total, other adverse events | Pregnancy Cohort | 0 | 0 |
| Total, other adverse events | No Pregnancy Cohort | 0 | 0 |
| Total, serious adverse events | Pregnancy Cohort | 0 | 0 |
| Total, serious adverse events | No Pregnancy Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pregnant Cohort vs Non-pregnant Cohort: Overall Survival | Trial comparisons |
| Pregnant Cohort vs Non-pregnant Cohort: Breast Cancer-Specific Survival | Trial comparisons |
| Pregnancy Cohort vs No Pregnancy Cohort: deaths from any cause | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03673306
GET https://conductscience.org/api/trials/v1/NCT03673306/registered