Clinical trial NCT04289805: Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
Official title: A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Breast Neoplasm Malignant Female
Keywords: Fertility preservation
Letrozole
Ovarian stimulation
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2020-02-28
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups:

* 113 patients in the standard-stimulated cohort,
* 113 patients in the letrozole-stimulated cohort,
* 339 patients in the non-stimulated cohort.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected
timeFrame: an average of 2 weeks after inclusion
Secondary outcomes:
measure: Number of patient with adverse events due to COS: OHSS
timeFrame: Through treatment procedure, an average of 2 weeks after inclusion
measure: Characteristics of Ovarian stimulation: total gonadotropin doses
timeFrame: An average of 2 weeks after inclusion
measure: Characteristics of Ovarian stimulation: duration of the COS
timeFrame: An average of 2 weeks after inclusion
measure: Characteristics of Ovarian stimulation: type of stimulation
timeFrame: An average of 2 weeks after inclusion
measure: Efficacy of the ovarian stimulation and oocyte collection: Maturation rate
timeFrame: An average of 2 weeks after inclusion
measure: Outcomes of assisted reproductive technology procedures
timeFrame: Through study completion, 5 years
measure: Anticancer therapies effect on ovarian function: progesterone
timeFrame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
measure: Anticancer therapies effect on ovarian function: AMH
timeFrame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
measure: Anticancer therapies effect on ovarian function: FSH
timeFrame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
measure: Anticancer therapies effect on ovarian function: E2
timeFrame: Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months
measure: Anticancer therapies effect on ovarian function
timeFrame: An average 18 months, 30 months, 60 months after inclusion
measure: Oncological outcomes 1
timeFrame: 5 years
measure: Oncological outcomes 2
timeFrame: 5 years
measure: Oncological outcomes 3
timeFrame: 5 years
measure: Circulating breast cancer cells level before stimulation
timeFrame: Inclusion
measure: Circulating breast cancer cells level after stimulation
timeFrame: average of 2weeks after inclusion
measure: Number of patient with adverse events due to egg collection
timeFrame: An average of 2 weeks after inclusion
measure: Number of patient with adverse events due to egg collection
timeFrame: An average of 2 weeks after inclusion
measure: Efficacy of the in vitro fertilization procedure: Fertilization rate
timeFrame: Through study completion, 5 years
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: CUB-Hôpital Erasme
city: Brussel
country: Belgium
facility: CHIREC- Hospital Delta
city: Liège
country: Belgium
facility: CHC-Saint Vincent
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU Lille
city: Genova
country: Italy
facility: Ospedale San Martino
Study officials:
affiliation: CUB-Hôpital Erasme
name: Isabelle Demeestere, MD, PhD
role: STUDY_DIRECTOR
affiliation: ULB
name: Matteo Lambertini, MD, PhD
role: STUDY_CHAIR
affiliation: CHRU LILLE
name: Christine Decanter, MD
role: STUDY_CHAIR
References: