Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03673306
• Other study ID #: IJB-BRCAPreg-CE2630
• Status: Active, not recruiting
• Start date: January 16, 2017
• Est. completion date: June 2023

Study information

• Verified date: September 2018
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2200
• Est. completion date: June 2023
• Est. primary completion date: June 2019
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Diagnosis of invasive breast cancer between January 2000 and December 2012;

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Clinical outcomes
Clinical outcomes

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc UCL	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	University Hospitals Leuven, KU Leuven	Leuven
Brazil	Cancer Institute ICESP	São Paulo
France	Bergonie Institute	Bordeaux
France	Leon Berard Cancer Center	Lyon
France	Hopital Saint Louis	Paris
France	Institut Curie	Paris
France	Centre Henri Becquerel	Rouen
France	Institut Gustave Roussy	Villejuif
Israel	Sharett Institute of Oncology - Hadassah Hebrew University Medical Center	Jerusalem
Israel	Sheba Medical Center	Tel Aviv
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Oncological Center CRO	Aviano
Italy	Azienda Ospedaliera "Papa Giovanni XXIII"	Bergamo
Italy	Candiolo Cancer Center (IRCCS)	Candiolo
Italy	Policlinico San Martino - IRCCS per l'Oncologia	Genova
Italy	European Institute of Oncology	Milan
Italy	Azienda Ospedaliero-Universitaria Policlinico, University of Modena and Reggio Emilia	Modena
Italy	IOV (Istituto Oncologico Veneto)	Padova
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	AOU Policlinico Umberto I	Roma
Mexico	Instituto Nacional de Cancerologia	Mexico City
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
Portugal	Hospital de Santa Maria and Instituto de Medicina Molecular of the Faculty of Medicine of the University of Lisbon	Lisbon
Spain	Vall D'Hebron University Hospital	Barcelona
Spain	Hospital Universitari Son Espases Palma	Palma De Mallorca
Spain	INCLIVA, University Hospital of Valencia	Valencia
Switzerland	Oncology Institute of Southern Switzerland	Lugano
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  France,  Israel,  Italy,  Mexico,  Poland,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a pregnancy following breast cancer diagnosis	The incidence of pregnancy following breast cancer diagnosis will be computed as the ratio between the number of breast cancer survivors in the pregnant cohort and the total number of eligible patients included in the study.	10 years
Primary	Disease-free survival and overall survival	To evaluate the prognostic impact of pregnancy following breast cancer diagnosis in BRCA mutated survivors, two survival endpoints will be compared between patients with and without a pregnancy following breast cancer diagnosis: disease-free survival and overall survival. Disease-free survival event is defined by the occurrence of one of the following invasive events: local recurrence, distant metastases, contralateral or ipsilateral breast tumor, second primary malignancy, or death from any cause. Overall survival event is defined as death from any cause.	10 years
Secondary	Number of pregnancies resulting in live birth and number of children born	Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors	10 years
Secondary	Number of pregnancies resulting in induced and spontaneous abortion	Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors	10 years
Secondary	Number of pregnancies resulting in pregnancy complications (if any)	Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors	10 years
Secondary	Number of pregnancies resulting in fetal complication and/or congenital malformations (if any)	Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors	10 years
Secondary	Number of pregnancies resulting in obstetrical complications (if any)	Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors	10 years