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Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01503034
Enrollment
394
Registered
2012-01-02
Start date
2010-12-14
Completion date
2015-09-28
Last updated
2018-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Pregnant women

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.

Interventions

None listed

Sponsors

Centre Oscar Lambret
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival5 yearsThe overall survival corresponds to the time elapsed between the breast cancer diagnostic date and the death date.

Secondary

MeasureTime frameDescription
the support of breast cancer cases occured during pregnancy5 yearsDescription 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.).
Tumor characteristics5 yearsDescription of the tumor characteristics on the diagnostic biopsy or on the surgical specimen : histological type, Her2 status, hormone receptor status, etc.
Disease-free survival5 yearsThe disease-free survival is calculated from the time elapsed between the breast cancer diagnostic date and the first recurrence of the disease.
Case-control comparison5 yearsComparison 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026