Clinical trial NCT01503034: Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014
Official title: Study of Tumor Characteristics, Patient Care and Prognosis of Women With Breast Cancer During a Pregnancy Diagnosed Between 2000 and 2014
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Pregnant women
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 394
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study being retrospective, we will include all the subjects that meet our inclusion criteria over the period analyzed.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: the support of breast cancer cases occured during pregnancy
timeFrame: 5 years
measure: Tumor characteristics
timeFrame: 5 years
measure: Disease-free survival
timeFrame: 5 years
measure: Case-control comparison
timeFrame: 5 years
Other outcomes:
Locations:
city: Avignon
country: France
facility: Clinique Sainte Catherine
city: Baud
country: France
facility: Cabinet Dr Le Guen Naas
city: Besançon
country: France
facility: Centre Hospitalier Universitaire
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: CHR
city: Caen
country: France
facility: Centre François Baclesse
city: Cergy-Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Dechy
country: France
facility: Centre Léonard de Vinci
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental de Vendée
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Centre de Pharmacovigilance
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: CHRU La Peyronie et Centre Val d'Aurelle
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Tenon
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Reims
country: France
facility: Institut Jean Godinot
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Brieuc
country: France
facility: Clinique Radiologique
city: Saint Cloud
country: France
facility: Centre René Huguenin
city: Saint Herblain
country: France
facility: Centre René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Régaud
city: Tourcoing
country: France
facility: Cabinet Dr Leroy
city: Tours
country: France
facility: Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan
city: Vandoeuvre-Les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Oscar Lambret
name: Laurence VANLEMMENS, MD
role: PRINCIPAL_INVESTIGATOR
References: