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

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

Official Title
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Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity in Women With Breast Cancer in China

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: GnRHa


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRHa group<br>Eligible patients with breast cancer treated with GnRHa while receiving chemotherapy. | Drug: GnRHa<br>* 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.<br>* Other names: goserelin;|
| No Intervention: None GnRHa group<br>Eligible patients with breast cancer treated without GnRHa while receiving chemotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Premature Ovarian Insufficiency | 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. | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | Overall Survival & Tumor Free Survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRHa, ovarian function, anti-mullerian hormone