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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: standard chemotherapy; Drug: goserelin

Study type: Interventional

Funder types: Other

Identifiers

NCT02483767

PUMCH-BC-ovarian suppression

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

standard chemotherapy with goserelin

Experimental group

Description:

standard chemotherapy with the GnRH agonist goserelin

Treatment:

Drug: goserelin

Drug: standard chemotherapy

standard chemotherapy without goserelin

Active Comparator group

Description:

standard chemotherapy without goserelin

Treatment:

Drug: standard chemotherapy