Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01503034
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).

Detailed Description

Investigators will explain the purpose of the study to the eligible patients, still alive, and will inform them verbally and in writing, using the information note, of their possibility of refusal. No information will be made for deceased patients.

The investigators will complete the case report forms on paper and then will send them by mail.

Study Timeline

• Study Start: 2010-12-14
• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2011-12-30
• Study First Posted: 2012-01-02
• Primary Completion: 2015-09-28
• Study Completion: 2015-09-28
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 394

Inclusion Criteria

• Women aged 18 or over

• Confirmed histological diagnosis of invasive breast cancer

• No known metastasis

• For the cases :

  • Patients pregnant at the time of the first diagnosis
  • 1st diagnosis between 2000 and 2014

• For the controls :

  • Patients not pregnant at the time of the first diagnosis
  • 1st diagnosis between 2000 and 2009

Exclusion Criteria

• Patients who have undergone an induced abortion after the diagnosis of breast cancer
• Patients with a history of breast cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	The overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.

Secondary Outcome Measures

Name	Time	Method
Tumor characteristics	5 years	Description of the tumor characteristics on the diagnostic biopsy or on the surgical specimen : histological type, Her2 status, hormone receptor status, etc.
Disease-free survival	5 years	The disease-free survival is calculated from the time elapsed between the breast cancer diagnostic date and the first recurrence of the disease.
Case-control comparison	5 years	Comparison of the tumoral characteristics, the patient care and the prognosis of women with breast cancer appeared during a pregnancy, with non-pregnant women of the same age.
the support of breast cancer cases occured during pregnancy	5 years	Description of the anti-tumor treatment (surgery, radiotherapy, chemotherapy, hormone therapy, targeted therapy), of the imaging performed and of the childbirth (programmed or not, vaginal or caesarean section, baby's condition at birth, etc.).

Trial Locations

Locations (37)

Centre Hospitalier Universitaire; 🇫🇷 Besançon, France

Centre Léonard de Vinci; 🇫🇷 Dechy, France

Cabinet Dr Leroy; 🇫🇷 Tourcoing, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut Curie; 🇫🇷 Paris, France

Clinique Sainte Catherine; 🇫🇷 Avignon, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Hospitalier René Dubos; 🇫🇷 Cergy-Pontoise, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHRU La Peyronie et Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Cabinet Dr Le Guen Naas; 🇫🇷 Baud, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre René Gauducheau; 🇫🇷 Saint Herblain, France

Centre Catherine de Sienne; 🇫🇷 Nantes, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre René Huguenin; 🇫🇷 Saint Cloud, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre de Pharmacovigilance; 🇫🇷 Lille, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Tenon; 🇫🇷 Paris, France

Centre Hospitalier Lyon-Sud; 🇫🇷 Pierre-Bénite, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Clinique Radiologique; 🇫🇷 Saint Brieuc, France

CHR; 🇫🇷 Brest, France

Centre Hospitalier de Bretagne Sud; 🇫🇷 Lorient, France

Institut Jean Godinot; 🇫🇷 Reims, France

Polyclinique de Courlancy; 🇫🇷 Reims, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-Les-Nancy, France

Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan; 🇫🇷 Tours, France

Centre Hospitalier Départemental de Vendée; 🇫🇷 La Roche sur Yon, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Institut Claudius Régaud; 🇫🇷 Toulouse, France