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

Centre Oscar Lambret

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: Oocyte/embryo freezing; Procedure: Controlled ovarian hyperstimulation (COH)

Study type: Interventional

Funder types: Other

Identifiers

NCT02871167

CHACRY-1501

PHRC-K14-010 (Other Grant/Funding Number)

2016-000808-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Oocyte/embryo cryopreservation

Experimental group

Description:

1. Controlled ovarian hyperstimulation (COH) 2. Oocyte/embryo freezing

Treatment:

Procedure: Controlled ovarian hyperstimulation (COH)

Procedure: Oocyte/embryo freezing