Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity

Phase 3

Completed

Brief Summary: This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.

Recruitment & Eligibility

Inclusion Criteria

Premenopausal women 18 to 49 years of age are eligible for enrollment
Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.
Human chorionic gonadotropin negative by urine test before entering the group.
Informed consent, understanding and compliance with the requirements of the study.
No significant chronic disease and any organ dysfunction.

Exclusion Criteria

Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.
Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.
Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.
Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.
Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.
Allergic to active or inactive excipients of GnRHa is an exclusion criterion.

Arm && Interventions

Group	Intervention	Description
GnRHa group	GnRHa	Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Premature Ovarian Insufficiency	1 years	The serum levels of anti-Müllerian hormone (AMH) were measured using human AMH ELISA kit (11351, Biofine)). POI (premature ovarian insufficiency) was defined as AMH\<0.5ng/mL in this study.

Secondary Outcome Measures

Name	Time	Method
Survival Rate	5 years	Overall Survival \& Tumor Free Survival

Locations (2): Shanghai Jiao Tong University Affiliated Sixth People's Hospital
🇨🇳
Shanghai, China
Zhejiang Cancer Hospital
🇨🇳
Hangzhou, Zhejiang, China