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

• Status: Recruiting
• Trial end date: 2027-01-25
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasme University Hospital
• Collaborator: University Hospital, Lille
• Treatments: Letrozole

Criteria

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.