Fertility Preservation in Breast Cancer Patients (Brovale)

Free University of Brussels (ULB)

Status and phase: Completed; Phase 4

Conditions: Fertility; Breast Neoplasms

Treatments: Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT02661932

BC-POF 2012

Details and patient eligibility

About

The purpose of this study is to evaluate efficiency and safety of controlled ovarian stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility preservation in breast cancer patients.

Full description

Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a GnRH agonist since amendment P2015/091 (Decapeptyl 0,2mg).

At oocyte retrieval, aspirated follicular fluid is separated from the flush medium for hormonal assays, and oocytes are denuded for ICSI(Intra Cytoplasmic Sperm Injection) or vitrification. Cumulus cells are collected for subsequent analysis of oocyte quality gene expression.

A. Primary objective of the study is to evaluate efficiency of letrozole associated ovarian stimulation for fertility preservation in breast cancer patients in terms of oocyte maturation rate.

Patients' results for primary endpoint are prospectively compared to infertile patients undergoing COS without letrozole.

B. Secondary objectives of the study aim to evaluate safety of the protocol:

1. Estradiol and progesterone levels at ovulation triggering, ovulation and during luteal phase after oocyte retrieval (days 3 and 8)
2. The risk of disease relapse will be assessed by long-term follow-up of these patients (up to 5 years) as well as an evaluation of circulating tumoral DNA before and after ovarian stimulation.
3. Finally obstetrical outcomes will also be recorded.

Enrollment: 65 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer female patients of less than 41 years old
• Addressed to fertility preservation Unit before starting chemotherapy

Exclusion criteria

• Metastatic breast cancer
• Known premature ovarian failure
• Basal FSH > 20 IU(International Unit)
• Surgical contra-indications

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Letrozole associated COS

Experimental group

Description:

Breast cancer patients undergo fertility preservation with letrozole associated COS for oocyte collection. Letrozole is administered orally (5mg/day) during the entire stimulation protocol until ovulation triggering.

Treatment:

Drug: Letrozole