Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
Megadott ok: The study had to be terminated due to the new European legislation on drug studies. This legislation requires all studies aimed at evaluating treatments to be registered as such, even in the context of Standard of Care.
Key facts
- Where
- Brussels és Liège, BelgiumSee the 3 sites
- Phase
- 4. fázis
Where in Belgium
- CHIREC- Hospital DeltaBrussels, BelgiumNo longer taking part
- CUB Hôpital ErasmeBrussels, BelgiumNo longer taking part
- CHC-Saint VincentLiège, BelgiumNo longer taking part
Trial details
- Who runs it
- Erasme University Hospital
- Trial code
- NCT04289805
- Record updated
- 2025. január 31.
- Original description
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.Read full original descriptionShow less
A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
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.
Inclusion: 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: Prior diagnosis of other malignancies before breast cancer; Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer).