Fertility preservation in patients with breast cancer. - FPR-09-01

• Conditions: MedDRA version: 9.1Level: PTClassification code 10003539; Fertility preservation in patients with breast cancer; MedDRA version: 9.1Level: HLGTClassification code 10006291

• Registration Number: EUCTR2009-014601-13-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-08
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

? Female sex ? Reproductive age (18 years, 40 years) •Patients with breast cancer of first diagnosis waiting for antineoplastic therapies (stadio I, stadio IIA, Stadio IIB TNM classification).
•To get informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with positive Beta-HCG before ovarian stimulation.
•Patients with metastasis.
•Known or suspected hypersensitivity to drugs in study.
•Serious clinical conditions.
•Use of experimental drugs in the last 6 months before inclusion in the study .
•Patients unable to follow the protocol or to sign the informed consent .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to preserve fertility by oocyte cryopreservation in patients with breast cancer utilizing gonadotropins (Gonal-F ?) in combination with aromatase inhibitor (Femara ?) for maintaining estradiol levels similar to unstimulated cycles.;Secondary Objective: 1)to evaluate safety of the experimental treatment on patients during ovarian stimulation.<br>2)to evaluate safety of the experimental treatment on newborns after oocyte thawing;Primary end point(s): 1)number of oocytes stored for each patient.<br>2)peak estradiol levels reached during ovarian stimulation for each patient.