Clinical trial NCT02518191: Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity
Official title: Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: GnRHa
ovarian function
anti-mullerian hormone
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
First posted: 2015-08-07
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Premature Ovarian Insufficiency
timeFrame: 1 years
Secondary outcomes:
measure: Survival Rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study officials:
affiliation: Shanghai Jiao Tong University affiliated 6th Hospital
name: XIANGYUN ZONG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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