Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation

Breast Cancer Clinical Trial

— CHACRY-1501  

Official title:

Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871167
• Other study ID #: CHACRY-1501
• Secondary ID: 2016-000808-28PH
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: Centre Oscar Lambret
• Contact: Audrey Maillez, MD
• Email: a-mailliez[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.

Description:

Medical Oncology: - Information and collection of consent, - Imaging staging, - Inclusion - Physical examination - Contraception advise given Reproductive medicine center: - Ovarian reserve assessment: serum anti-mullerian hormone (AMH) measurement and antral follicle count (AFC) by ultrasound. - Serology syphilis, hepatitis B and C, HIV (human immunodeficiency virus). In case of embryo cryopreservation, same serology determination for the men. - Infertility risk and fertility preservation techniques information. - In case of agreement, this technique will be done during the time-interval between surgery and chemotherapy - Fertility preservation (COH stimulation, triggering and oocyte retrieval) Adjuvant chemotherapy: - The chemotherapy regimen is 3 FEC (fluorouracil epirubicin cyclophosphamide) 100 followed by standard chemotherapy (according to local practice) +/- Trastuzumab. Adjuvant chemotherapy may only begin after the oocyte retrieval. - Usual adjuvant chemotherapy is not changed During chemotherapy: - Clinical exam before each cycle of chemotherapy - AMH, AFC at cycle 6 After chemotherapy: - Usual patient monitoring in expert center : physical examination at Month 3 (M3), M6 M9 M12 M18 and M24 and mammography at M9 then annual - AMH at Month 3 (M3), M6 M9 M12 M18 and M24 - AFC at Month 12 (M12) and M24

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• Women with histologically proven breast cancer
• Aged 18 to 38 years old
• Planned adjuvant chemotherapy
• No prior chemotherapy
• Affiliated to a public health insurance program
• Informed consent signed by the patient

Exclusion Criteria:

• Metastatic breast cancer
• Planned neo-adjuvant chemotherapy
• Hysterectomy
• Exclusive adjuvant hormonotherapy
• Positive serology for syphilis, hepatitis B or C, or VIH
• Contraindication related to use of r-FSH
• Pregnant or breastfeeding patients

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Infertility

Intervention

Procedure:
• Controlled ovarian hyperstimulation (COH)
After information and consent, patients are addressed to a reproductive medicine center. The COH will be performed according to a standardized protocol between surgery and the start of adjuvant chemotherapy. Follicular growth will be achieved with an antagonist protocol and by using high dose recombinant FSH (r-FSH). The triggering of the final follicular and oocyte maturation will be obtained by a GnRH (Gonadotropin Releasing Hormone) agonist injection in order to minimize the risk of ovarian hyper-stimulation.
• Oocyte/embryo freezing
Egg or embryo freezing will be performed according to a standardized protocol: slow-freezing process for embryo; vitrification technique for oocytes. Cryopreserved oocytes and embryos will be stored in the biological bank of each reproductive medicine center (min. 10 years).

Locations

Country	Name	City	State
France	Hôpital Jean Verdier	Bondy
France	Centre Aliénor d'Aquitaine, Hôpital Pellegrin	Bordeaux
France	Centre François Baclesse	Caen
France	CHU de Caen	Caen
France	Hôpital Antoine Béclère	Clamart
France	Centre Georges François LECLERC	Dijon
France	CHU de Dijon	Dijon
France	CHU REUNION site SUD	La Réunion
France	Centre Oscar Lambret	Lille
France	CHRU Hôpital Jeanne de Flandres	Lille
France	CHU Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	CHU Lyon	Lyon
France	CHU La Conception	Marseille
France	Institut Paoli Calmette	Marseille
France	CHRU Montpellier	Montpellier
France	ICM - Val d'Aurelle	Montpellier
France	CHRU de Nancy	Nancy
France	Hôpital Cochin	Paris
France	Hôpital TENON	Paris
France	Institut Curie	Paris
France	Centre Henri Becquerel	Rouen
France	CHU Rouen	Rouen
France	Institut Curie	Saint-Cloud
France	Hôpital Universitaire de Strasbourg	Strasbourg
France	Oncopole-CHU Toulouse	Toulouse
France	Institut de Cancérologie de Lorraine	Vandoeuvre les nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (4)

Lead Sponsor	Collaborator
Centre Oscar Lambret	National Cancer Institute, France, University Hospital, Lille, University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Translational research : circulating nucleic acids quantification: cell-free DNA and microRNAs on blood sample	before 1st cycle of adjuvant chemotherapy, during the adjuvant chemotherapy (end of first sequence), at the end of adjuvant chemotherapy	an average of 6 months
Primary	Quality of oocytes: total number of oocytes preserved	The distribution of the total number of oocytes preserved will be summarized by the mean (standard error) and median (range) and presented with a 95% confidence interval.	after oocyte retrieval (35-36 hours after triptorelin injection)
Secondary	Quality of embryos: total number of embryos preserved		at 44-46 hours post intra-cell sperm injection
Secondary	Type of oocytes	mature, immature, fractured	after oocyte retrieval (35-36 hours after triptorelin injection)
Secondary	Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale	Toxicities will be tabulated with frequencies and percentages by type of adverse events and by grade	24 months
Secondary	Serum AMH measurement		baseline, at the end of the first sequence of chemotherapy, at the last injection of treatment, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Secondary	Antral Follicular Count (AFC) measurement		baseline, at month 3, at month 12, at month 24
Secondary	Number of Spontaneous or medically assisted pregnancy(ies)	To measure the degree of project completion of subsequent pregnancy(ies)	up to 10 years after the end of the study or at 43 years old
Secondary	Rate of patients wishing for re-utilization of their frozen gametes	To assess the number of patients wishing for re-utilization of their frozen gametes	up to 10 years after the end of the study or at 43 years old
Secondary	Disease-free survival	defined as the interval between inclusion and the first occurrence of local, regional or distant relapse, estimated using the Kaplan-Meier method	through study completion, an average of 5 years