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Completed

NCT Number: NCT01503034

Pregnant Women With a Breast Cancer 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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clinique Sainte Catherine, Avignon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 5 years

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

Secondary outcomes

  1. 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.).

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 2, 2012
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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