Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014

March 30, 2018 updated by: Centre Oscar Lambret

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

394

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Clinique Sainte Catherine
      • Baud, France, 56150
        • Cabinet Dr Le Guen Naas
      • Besançon, France, 25030
        • Centre Hospitalier Universitaire
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Brest, France, 29609
        • CHR
      • Caen, France, 14076
        • Centre François Baclesse
      • Cergy-Pontoise, France, 95300
        • Centre Hospitalier Rene Dubos
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Dechy, France, 59187
        • Centre Leonard de Vinci
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Departemental de Vendee
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59045
        • Centre de Pharmacovigilance
      • Lorient, France, 56322
        • Centre Hospitalier de Bretagne Sud
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Montpellier, France, 34298
        • CHRU La Peyronie et Centre Val d'Aurelle
      • Nantes, France, 44202
        • Centre Catherine de Sienne
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75010
        • Hopital Saint-Louis
      • Pierre-Bénite, France, 69310
        • Centre Hospitalier Lyon-Sud
      • Reims, France, 51056
        • Institut Jean Godinot
      • Reims, France, 51100
        • Polyclinique de Courlancy
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Brieuc, France, 22015
        • Clinique Radiologique
      • Saint Cloud, France, 92210
        • Centre René Huguenin
      • Saint Herblain, France, 44805
        • Centre Rene Gauducheau
      • Strasbourg, France, 67065
        • Centre PAUL STRAUSS
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tourcoing, France, 59200
        • Cabinet Dr Leroy
      • Tours, France, 37000
        • Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan
      • Vandoeuvre-Les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
The overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the support of breast cancer cases occured during pregnancy
Time Frame: 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.).
5 years
Tumor characteristics
Time Frame: 5 years
Description of the tumor characteristics on the diagnostic biopsy or on the surgical specimen : histological type, Her2 status, hormone receptor status, etc.
5 years
Disease-free survival
Time Frame: 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.
5 years
Case-control comparison
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Laurence VANLEMMENS, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2010

Primary Completion (Actual)

September 28, 2015

Study Completion (Actual)

September 28, 2015

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

December 30, 2011

First Posted (Estimate)

January 2, 2012

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cancer et grossesse

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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