Clinical trial · Observational
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
NCT03673306CI-TRIAL-00083727completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical outcomes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pregnant cohort
- description
- Women with one or more pregnancies any time after breast cancer diagnosis
- interventionNames
- Other: Clinical outcomes
- label
- Non-pregnant cohort
- description
- Women with no subsequent pregnancies after breast cancer diagnosis
- interventionNames
- Other: Clinical outcomes
Primary outcomes (2)
- measure
- Disease-free Survival
- timeFrame
- 10 years
- description
- The primary end points were the cumulative incidence of pregnancy and disease-free survival.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (5)
- RESULTLambertini M, Ameye L, Hamy AS, Zingarello A, Poorvu PD, Carrasco E, Grinshpun A, Han S, Rousset-Jablonski C, Ferrari A, Paluch-Shimon S, Cortesi L, Senechal C, Miolo G, Pogoda K, Perez-Fidalgo JA, De Marchis L, Ponzone R, Livraghi L, Estevez-Diz MDP, Villarreal-Garza C, Dieci MV, Clatot F, Berliere M, Graffeo R, Teixeira L, Cordoba O, Sonnenblick A, Luna Pais H, Ignatiadis M, Paesmans M, Partridge AH, Caron O, Saule C, Del Mastro L, Peccatori FA, Azim HA Jr. Pregnancy After Breast Cancer in Patients With Germline BRCA Mutations. J Clin Oncol. 2020 Sep 10;38(26):3012-3023. doi: 10.1200/JCO.19.02399. Epub 2020 Jul 16. PMID 32673153
- RESULTLambertini M, Blondeaux E, Agostinetto E, Hamy AS, Kim HJ, Di Meglio A, Bernstein Molho R, Hilbers F, Pogoda K, Carrasco E, Punie K, Bajpai J, Ignatiadis M, Moore HCF, Phillips KA, Toss A, Rousset-Jablonski C, Peccatori FA, Renaud T, Ferrari A, Paluch-Shimon S, Fruscio R, Cui W, Wong SM, Vernieri C, Ruddy KJ, Dieci MV, Matikas A, Rozenblit M, Villarreal-Garza C, De Marchis L, Del Mastro L, Puglisi F, Del Pilar Estevez-Diz M, Rodriguez-Wallberg KA, Mrinakova B, Meister S, Livraghi L, Clatot F, Yerushalmi R, De Angelis C, Sanchez-Bayona R, Meattini I, Cichowska-Cwalinska N, Berliere M, Salama M, De Giorgi U, Sonnenblick A, Chiodi C, Lee YJ, Maria C, Azim HA Jr, Boni L, Partridge AH; BRCA BCY Collaboration. Pregnancy After Breast Cancer in Young BRCA Carriers: An International Hospital-Based Cohort Study. JAMA. 2024 Jan 2;331(1):49-59. doi: 10.1001/jama.2023.25463. PMID 38059899
- DERIVEDToss A, Blondeaux E, Tenedini E, Bonamici L, Graffeo R, Livraghi L, Villarreal-Garza C, Bernstein Molho R, Kwong A, Balmana J, Wildiers H, Agostinetto E, Phillips KA, Pogoda K, Renaud T, Rousset-Jablonski C, Ferrari A, Moore HCF, Peccatori FA, Paluch-Shimon S, Fruscio R, Micheri C, Wong SM, Cui W, Vernieri C, Lee MK, De Marchis L, Couch FJ, Del Mastro L, Puglisi F, Meireles PA, Kemp Z, Matikas A, Plichta J, Del Pilar Estevez-Diz M, Di Meglio A, Cichowska-Cwalinska N, Gianni C, Yerushalmi R, Sanchez-Bayona R, Mrinakova B, Matos L, Bianchini G, Caleffi M, Krivokuca A, Abdou Y, Marino-Marino M, Parokonnaya A, Okano M, Antone N, Saavedra C, Sonnenblick A, Duchnowska R, Pais HL, Harbeck N, Cortesi L, Delucchi V, De Angelis C, Lambertini M. Association between type and location of germline BRCA1/2 pathogenic or likely pathogenic variants with phenotype and prognosis in young patients with breast cancer: results from an international cohort study. Ann Oncol. 2026 Mar;37(3):364-377. doi: 10.1016/j.annonc.2025.11.004. Epub 2025 Nov 17.