Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
- Conditions
- Breast Neoplasm Malignant Female
- Interventions
- Other: standard-stimulated cohort
- Registration Number
- NCT04289805
- Lead Sponsor
- Erasme University Hospital
- Brief Summary
This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.
- Detailed 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 Gonadotropin Releasing Hormone-GnRH agonist.
After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.
Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 96
- Diagnosis of invasive non-metastatic breast cancer (i.e. stage I to III);
- Breast cancer diagnosis ≥18 and ≤ 40 years;
- No prior history of gonadotoxic treatments;
- Fertility preservation counseling for fertility preservation;
- Written inform consent;
- FSH < 20 UI/L and/or antra-follicular count ≥ 6 (follicles of 2-9 mm) and/or AMH ≥ 6 pmol (only applicable for patients who undergo controlled ovarian stimulation for embryo/oocyte cryopreservation).
- Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);
- Prior diagnosis of other malignancies before breast cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard-stimulated cohort standard-stimulated cohort this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the French participating centres. letrozole-stimulated cohort Letrozole this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the Belgian participating centres.
- Primary Outcome Measures
Name Time Method Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected an average of 2 weeks after inclusion Number of mature oocytes collected
- Secondary Outcome Measures
Name Time Method Efficacy of the ovarian stimulation and oocyte collection: Maturation rate An average of 2 weeks after inclusion Maturation rate (number of total oocyte collected/number of mature oocytes)
Anticancer therapies effect on ovarian function: FSH Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months Follicle-Stimulating Hormone (FSH) measurements FSH IU/L
Characteristics of Ovarian stimulation: duration of the COS An average of 2 weeks after inclusion duration of the COS (days)
Characteristics of Ovarian stimulation: type of stimulation An average of 2 weeks after inclusion type of stimulation (standard or random-start).
Number of patient with adverse events due to COS: OHSS Through treatment procedure, an average of 2 weeks after inclusion Adverse events reporting during COS (Ovarian Hyperstimulation syndrome-OHSS)
Circulating breast cancer cells level after stimulation average of 2weeks after inclusion circulating tumor DNA (ctDNA)
Number of patient with adverse events due to egg collection An average of 2 weeks after inclusion pelvic infection
Anticancer therapies effect on ovarian function: AMH Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months Anti-Mullerian Hormone (AMH) measurements AMH ng/ml
Oncological outcomes 1 5 years Invasive disease-free survival (iDFS)
Efficacy of the in vitro fertilization procedure: Fertilization rate Through study completion, 5 years Fertilization rate (number of oocyte fertilized/number of embryo obtained)
Characteristics of Ovarian stimulation: total gonadotropin doses An average of 2 weeks after inclusion Total gonadotropin doses (International Unit- IU)
Anticancer therapies effect on ovarian function An average 18 months, 30 months, 60 months after inclusion Amenorrhea rate (6months without spontaneous menstruation)
Oncological outcomes 2 5 years breast cancer-free interval (BCFI)
Outcomes of assisted reproductive technology procedures Through study completion, 5 years Number of pregnancies and outcomes (premature delivery, miscarriage, abortion, delivery healthy babies, congenital malformation).
Anticancer therapies effect on ovarian function: progesterone Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months Hormonal measurements Progesterone ng/ml
Anticancer therapies effect on ovarian function: E2 Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months Hormonal measurements E2 pg/ml
Oncological outcomes 3 5 years overall survival (OS)
Circulating breast cancer cells level before stimulation Inclusion circulating tumor DNA (ctDNA)
Trial Locations
- Locations (6)
CUB-Hôpital Erasme
🇧🇪Brussel, Belgium
CHIREC- Hospital Delta
🇧🇪Brussel, Belgium
CHC-Saint Vincent
🇧🇪Liège, Belgium
Centre Oscar Lambret
🇫🇷Lille, France
CHRU Lille
🇫🇷Lille, France
Ospedale San Martino
🇮🇹Genova, Italy