Fertility Preservation in Breast Cancer Patients

NCT02661932 | Completed Phase 4

• 1 other identifier: BC-POF 2012
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate efficiency and safety of controlled ovarian stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility preservation in breast cancer patients.

Conditions

Breast Neoplasms; Fertility

Keywords

Fertility preservation; letrozole; Ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• Oocyte maturation rate

  Following letrozole associated COS, oocytes are collected and evaluated for maturation rate (%). These results are prospectively compared to infertile patients undergoing similar COS (GnRH antagonist protocol) without letrozole.

  At oocyte collection (48 hours after last administration of letrozole, following COS protocol).

Secondary Outcomes (8)

• Hormonal levels

  during stimulation at ovulation trigger and oocyte retrieval and during luteal phase (days 3 and 8)

• Circulating tumoral DNA

  At enrollment (before letrozole associated COS) and at oocyte retrieval (48 hours after last administration of letrozole, following COS protocol)

• Comparison of breast cancer recurrence rate in patients who underwent letrozole associated COS with an oncological control group

  2 and 5 years after letrozole associated COS

• Ovarian reserve

  At enrollment, 2 and 5 years after letrozole associated COS for fertility preservation

• Obstetrical outcome: malformation rate

  Through study completion: data collection at 2 and 5 years after letrozole associated COS

Study Arms (1)

Letrozole associated COS

EXPERIMENTAL

Breast cancer patients undergo fertility preservation with letrozole associated COS for oocyte collection. Letrozole is administered orally (5mg/day) during the entire stimulation protocol until ovulation triggering.

Drug: Letrozole

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 2 tablets per day (2,5mgx2/d) from cycle day 2 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering. GnRH antagonist is administered as soon as at least one follicle reaches 14 mm. "Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins and GnRH antagonist, until ovulation triggering. Oocytes are collected 36h after ovulation triggering. All patients receive GnRH antagonist after oocyte retrieval for 3-7 days or until chemotherapy starts, to induce luteolysis.

Also known as: Femara

Letrozole associated COS

Eligibility Criteria

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

You may qualify if:

• Breast cancer female patients of less than 41 years old
• Addressed to fertility preservation Unit before starting chemotherapy

You may not qualify if:

• Metastatic breast cancer
• Known premature ovarian failure
• Basal FSH \> 20 IU(International Unit)
• Surgical contra-indications

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme-CUB

Brussels, 1070, Belgium

Location

Related Publications (4)

• Goldrat O, De Cooman M, Mailliez A, Delbaere A, D'Orazio E, Demeestere I, Decanter C. Efficacy and safety of controlled ovarian hyperstimulation with or without letrozole for fertility preservation in breast cancer patients: A multicenter retrospective study. Eur J Cancer. 2022 Oct;174:134-141. doi: 10.1016/j.ejca.2022.07.017. Epub 2022 Aug 20.

  PMID: 35998549 RESULT

• Goldrat O, Delbaere A, Demeestere I. Impact of letrozole-associated controlled ovarian hyperstimulation on ART outcomes and endocrinological parameters. Hum Reprod. 2022 Oct 31;37(11):2722-2723. doi: 10.1093/humrep/deac206. No abstract available.

  PMID: 36124889 RESULT

• Goldrat O, Gervy C, Englert Y, Delbaere A, Demeestere I. Progesterone levels in letrozole associated controlled ovarian stimulation for fertility preservation in breast cancer patients. Hum Reprod. 2015 Sep;30(9):2184-9. doi: 10.1093/humrep/dev155. Epub 2015 Jun 24.

  PMID: 26109617 RESULT

• Goldrat O, Van Den Steen G, Gonzalez-Merino E, Dechene J, Gervy C, Delbaere A, Devreker F, De Maertelaer V, Demeestere I. Letrozole-associated controlled ovarian hyperstimulation in breast cancer patients versus conventional controlled ovarian hyperstimulation in infertile patients: assessment of oocyte quality related biomarkers. Reprod Biol Endocrinol. 2019 Jan 3;17(1):3. doi: 10.1186/s12958-018-0443-x.

  PMID: 30606204 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Isabelle Demeestere

  Erasme-CUB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 25, 2016
• Study Start: November 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2024
• Last Updated: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)