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

NCT04289805 | Terminated Phase 4 DMC

• 1 other identifier: SRB_201808_163
• Study Type: interventional
• Target: 96
• Locations: 3 countries
• Sites: 6

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.

Conditions

Breast Neoplasm Malignant Female

Keywords

Fertility preservation; Letrozole; Ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected

  Number of mature oocytes collected

  an average of 2 weeks after inclusion

Secondary Outcomes (19)

• Number of patient with adverse events due to COS: OHSS

  Through treatment procedure, an average of 2 weeks after inclusion

• Characteristics of Ovarian stimulation: total gonadotropin doses

  An average of 2 weeks after inclusion

• Characteristics of Ovarian stimulation: duration of the COS

  An average of 2 weeks after inclusion

• Characteristics of Ovarian stimulation: type of stimulation

  An average of 2 weeks after inclusion

• Efficacy of the ovarian stimulation and oocyte collection: Maturation rate

  An average of 2 weeks after inclusion

Study Arms (3)

standard-stimulated cohort

ACTIVE COMPARATOR

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.

Other: standard-stimulated cohort

letrozole-stimulated cohort

EXPERIMENTAL

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.

Drug: Letrozole

non-stimulated cohort

NO INTERVENTION

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.

Interventions

Letrozole DRUG

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol. "Standard Protocol": letrozole is orally administered (5mg/d) from cycle day 2-3 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering. "Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins. GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm. Oocytes are collected 36h after ovulation triggering with GnRH agonist.

Also known as: Controlled Ovarian Stimulation (COS)

letrozole-stimulated cohort

standard-stimulated cohort OTHER

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol. "Standard Protocol": Gonadotrophins started from cycle day 2-3 throughout the ovarian stimulation until ovulation triggering. "Random start" protocol: Gonadotrophins started at any time of the cycle and throughout the stimulation. GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm. Oocytes are collected 36h after ovulation triggering with GnRH agonist.

Also known as: COS

standard-stimulated cohort

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead
• University Hospital, Lille: collaborator

Study Sites (6)

CUB-Hôpital Erasme

Brussels, 1070, Belgium

Location

CHIREC- Hospital Delta

Brussels, 1160, Belgium

Location

CHC-Saint Vincent

Liège, 4000, Belgium

Location

Centre Oscar Lambret

Lille, 59000, France

Location

CHRU Lille

Lille, 59037, France

Location

Ospedale San Martino

Genova, 16132, Italy

Location

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Isabelle Demeestere, MD, PhD

  CUB-Hôpital Erasme

  STUDY DIRECTOR

• Matteo Lambertini, MD, PhD

  ULB

  STUDY CHAIR

• Christine Decanter, MD

  CHRU LILLE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 groups: * 113 patients in the standard-stimulated cohort, * 113 patients in the letrozole-stimulated cohort, * 339 patients in the non-stimulated cohort.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: February 28, 2020
• Study Start: February 25, 2019
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); FR (2); IT (1)