Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014

Breast Cancer Clinical Trial

Official title:

Study of Tumor Characteristics, Patient Care and Prognosis of Women With Breast Cancer During a Pregnancy Diagnosed Between 2000 and 2014

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503034
• Other study ID #: Cancer et grossesse
• Status: Completed
• First received: December 30, 2011
• Last updated: March 30, 2018
• Start date: December 14, 2010
• Est. completion date: September 28, 2015

Study information

• Verified date: March 2018
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: September 28, 2015
• Est. primary completion date: September 28, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
France	Clinique Sainte Catherine	Avignon
France	Cabinet Dr Le Guen Naas	Baud
France	Centre Hospitalier Universitaire	Besançon
France	Institut Bergonié	Bordeaux
France	CHR	Brest
France	Centre François Baclesse	Caen
France	Centre Hospitalier René Dubos	Cergy-Pontoise
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Léonard de Vinci	Dechy
France	Centre Georges François Leclerc	Dijon
France	Centre Hospitalier Départemental de Vendée	La Roche sur Yon
France	Centre de Pharmacovigilance	Lille
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier de Bretagne Sud	Lorient
France	Centre Léon Bérard	Lyon
France	Institut Paoli Calmettes	Marseille
France	CHRU La Peyronie et Centre Val d'Aurelle	Montpellier
France	Centre Catherine de Sienne	Nantes
France	Centre Antoine Lacassagne	Nice
France	Hôpital Cochin	Paris
France	Hôpital Saint-Louis	Paris
France	Hôpital Tenon	Paris
France	Institut Curie	Paris
France	Centre Hospitalier Lyon-Sud	Pierre-Bénite
France	Institut Jean Godinot	Reims
France	Polyclinique de Courlancy	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Clinique Radiologique	Saint Brieuc
France	Centre René Huguenin	Saint Cloud
France	Centre René Gauducheau	Saint Herblain
France	Centre Paul Strauss	Strasbourg
France	Institut Claudius Régaud	Toulouse
France	Cabinet Dr Leroy	Tourcoing
France	Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan	Tours
France	Centre Alexis Vautrin	Vandoeuvre-Les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.	5 years
Secondary	the support of breast cancer cases occured during pregnancy	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.).	5 years
Secondary	Tumor characteristics	Description of the tumor characteristics on the diagnostic biopsy or on the surgical specimen : histological type, Her2 status, hormone receptor status, etc.	5 years
Secondary	Disease-free survival	The disease-free survival is calculated from the time elapsed between the breast cancer diagnostic date and the first recurrence of the disease.	5 years
Secondary	Case-control comparison	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.	5 years