The aim of this trial is to offer a safe and efficient alternative protocol to preserve fertility by storing oocytes in breast cancer patients before chemotherapy. Letrozole, an inhibitor of aromatase, is administered during standard gonadotropins ovarian stimulation to maintain a low estradiol level during ovarian stimulation in patients with hormono-sensitive tumour. MedDRA version: 18.1 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Femara
Product Name: Letrozole
Pharmaceutical Form: Film-coated tablet
Trade Name: Gonal-f 300IU
Product Name: hormone folliculo–stimulante humaine recombinante
Pharmaceutical Form: Solut
Sponsors
CUB - Hôpital Erasme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: -Woman 18-40 years old with breast cancer -Referred for fertility preservation at least 13 days before starting chemotherapy 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 54 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion criteria: -Breast cancer TxNxM1 -Premature ovarian failure -Poor ovarian function FSH>20mIU/ml -Surgical contraindication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the feasibility of gonadotropins ovarian stimulation associated with Letrozole before chemotherapy in breast cancer patients in order to preserve their fertility. ;Secondary Objective: The secondary objectives are to evaluate the efficiency (the success rate of the IVF, the feasibility of in vitro maturation of the immature oocytes collected) and the safety of the protocol for both patients and their offspring. ;Primary end point(s): The primary endpoint is to evaluate the feasability and the efficiency of the ovarian stimulation protocol (rate of mature oocytes collected and vitrify before chemotherapy). The maturation rate of oocytes collected will be compared to a prospective cohort of infertile patients treated with standard gonadotropins ovarian stimulation protocol without letrozole. ;Timepoint(s) of evaluation of this end point: Data collected at the time of oocytes collection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: -Evaluation of the success rate of the IVF (fertilization and implantation rate) -Evaluation of the feasibility of in vitro maturation of the immature oocytes collected. -Evaluation of the safety of the stimulation protocol: adverse events, estradiol peak, progesterone level, circulating tumoral DNA before and after stimulation, relapse-free survival rate after 5 years, follow-up of the pregnancies (major and minor malformation rate). The results will be compared with a prospective cohort of infertile patients having the same age but treated with standard ovarian stimulation protocol alone. The disease-free survival rate will be compared with a cohort of unstimulated patients having the same age and type of neoplasia.;Timepoint(s) of evaluation of this end point: Data are collected at day 0 (blood sample), at the end of the ovarian stimulation (adverse events, estradiol peak, number of immature oocytes), 24hours after oocytes retrieval (number of in vitro matured oocytes, fertilization rate), 3 and 8 days after oocytes retrieval (estradiol and progesterone levels). Data regarding the disease relapse are collected and the pregancies after 2 and 5 years of follow-up. | — |
Countries
Belgium
Contacts
Public ContactClinique de la fertilité
CUB - Hôpital Erasme
Outcome results
None listed