Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer

Peking Union Medical College Hospital98 enrolled

Overview

The study is a prospective randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). All patients are stratified according to age (\<35years vs.36-44years), hormone receptor status (HR+ or ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure, follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patients signed the written informed consent. * Histologically proven stage I, II, or III breast cancer * Must be candidates for adjuvant or neoadjuvant chemotherapy, * Must be premenopausal. * Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors. Exclusion Criteria: * The patients were previous chemotherapy; * Evidence of distant metastases; * Other malignancies in the previous 5 years. * The patients were using GnRHa, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy. * Pregnancy or lactation.

Outcomes

Primary Outcomes

ovarian failure

Ovarian failure is defined as amenorrhea for the preceding 6 months and follicle-stimulating hormone (FSH) and E2 levels in the post -menopausal range 2 year after the end of chemotherapy.

Time frame: 2 years

Secondary Outcomes

Ovarian dysfunction

Ovarian dysfunction is defined as amenorrhea for the preceding 3 months and follicle-stimulating hormone (FSH) and E2 levels in the post -menopausal range 1 year or 2year after the end of chemotherapy.

Time frame: 1 year

Time to the resumption of menstrual activity

Time to the resumption of menstrual activity will be assessed at 3month，1 year and 2year after the end of chemotherapy.

Time frame: 2 year

pregnancy

whether pregnancy will be accessed at 1year, 2year, 3year, 4year, 5year after the end of chemotherapy

Time frame: 5 year

DFS OS

Disease free survival (DFS) and overall survival (OS) will be assessed at 5years after the end of chemotherapy.

Time frame: 5 year

FSH,E2,AMH

FSH, estradiol, and anti-Mullerian hormone (AMH) levels in the postmenopausal range will be assessed at 3month，1 year and 2year after the end of chemotherapy.

Time frame: 2 year