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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014601-13-IT
Enrollment
Unknown
Registered
2011-02-08
Start date
2010-12-17
Completion date
Unknown
Last updated
2014-02-24

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

Conditions

Fertility preservation in patients with breast cancer MedDRA version: 9.1 Level: HLGT Classification code 10006291 MedDRA version: 9.1 Level: PT Classification code 10003539

Interventions

Trade Name: FEMARA Pharmaceutical Form: Tablet INN or Proposed INN: Letrozole Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Trade Name: GONAL F Pharmaceutic

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 .

Design outcomes

Primary

MeasureTime frame
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. 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. 2) peak estradiol levels reached during ovarian stimulation for each patient.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026