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

• Status: Completed
• Trial end date: 2021-01-12
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiangyun Zong
• Collaborators: First People's Hospital of Hangzhou; International Peace Maternity and Child Health Hospital; Shanghai 10th People's Hospital; Zhejiang Cancer Hospital
• Treatments: Goserelin

Criteria

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.