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

Xiangyun Zong

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: GnRHa

Study type

Interventional

Funder types

Other

Identifiers

NCT02518191

JTU-6H-20150731001

Details and patient eligibility

About

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

Enrollment

345 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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.