NCT01503034

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2015

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

4.8 years

First QC Date

December 30, 2011

Last Update Submit

March 30, 2018

Conditions

Keywords

Pregnant women

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.

    5 years

Secondary Outcomes (4)

  • the support of breast cancer cases occured during pregnancy

    5 years

  • Tumor characteristics

    5 years

  • Disease-free survival

    5 years

  • Case-control comparison

    5 years

Study Arms (2)

Study cohort

This cohort is made up of pregnant women with a breast cancer diagnosed between 2000 and 2014.

Compared cohort

This cohort is made up of non-pregnant women with a breast cancer diagnosed between 2000 and 2009.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study being retrospective, we will include all the subjects that meet our inclusion criteria over the period analyzed.

You may qualify if:

  • 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
  • st diagnosis between 2000 and 2014
  • For the controls :
  • Patients not pregnant at the time of the first diagnosis
  • st diagnosis between 2000 and 2009

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Clinique Sainte Catherine

Avignon, 84000, France

Location

Cabinet Dr Le Guen Naas

Baud, 56150, France

Location

Centre Hospitalier Universitaire

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

CHR

Brest, 29609, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Hospitalier René Dubos

Cergy-Pontoise, 95300, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Léonard de Vinci

Dechy, 59187, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Départemental de Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre de Pharmacovigilance

Lille, 59045, France

Location

Centre Hospitalier de Bretagne Sud

Lorient, 56322, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHRU La Peyronie et Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69310, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Polyclinique de Courlancy

Reims, 51100, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Clinique Radiologique

Saint-Brieuc, 22015, France

Location

Centre René Huguenin

Saint-Cloud, 92210, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Claudius Régaud

Toulouse, 31052, France

Location

Cabinet Dr Leroy

Tourcoing, 59200, France

Location

Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan

Tours, 37000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Laurence VANLEMMENS, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 2, 2012

Study Start

December 14, 2010

Primary Completion

September 28, 2015

Study Completion

September 28, 2015

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations