Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

Free University of Brussels (ULB)

Status and phase: Terminated; Phase 4

Conditions: Breast Neoplasm Malignant Female

Treatments: Other: standard-stimulated cohort; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT04289805

SRB_201808_163

Details and patient eligibility

About

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.

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 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.

Enrollment: 96 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);
• Prior diagnosis of other malignancies before breast cancer.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

standard-stimulated cohort

Active Comparator group

Description:

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.

Treatment:

Other: standard-stimulated cohort

letrozole-stimulated cohort

Experimental group

Description:

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.

Treatment:

Drug: Letrozole

non-stimulated cohort

No Intervention group

Description:

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and who have access to the Fertility Clinics in all the participating centres but are not willing to preserve their fertility by undergoing oocyte/embryo cryopreservation.