Goserelin 3.6 MG: In goserelin group, goserelin 3.6mg will be administered every 28 days by subcutaneous injection starting at least 7-14 days before the first cycle of chemotherapy and continued throughout chemotherapy duration.
Study summary
The purpose of this study is to assess efficacy of gonadotropin-releasing hormone agonist (goserelin) on the preservation of ovarian reserve function in young breast cancer patients treated with (neo)adjuvant chemotherapy by serial measuring ovarian reserve markers (AMH and AFC.etc) before and after chemotherapy and long-term pregnancy outcomes. Meanwhile, to evaluate the safety of this protective approach in young breast cancer patients by disease-free survival (DFS) and overall survival (OS) outcomes.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria:
For inclusion in the study patients must fulfil all of the following criteria:
1. Aged 45 years or younger
2. Have regular menstrual cycle
3. Newly diagnosed early-stage breast cancer (stages I to III)
4. Planned (neo)adjuvant chemotherapy
5. Signed informed consent document on file
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
1. Pregnancy or lactation
2. Oral contraceptives before enrollment
3. Prior chemotherapy
4. Bilateral oophorectomy or ovarian irradiation before enrollment
5. History of other cancers
6. GnRHa -containing adjuvant endocrine therapy
Primary outcome measure(s)
Recovery of serum AMH value(≥0.5ng/ml) in 2 years of post-chemotherapy — Phlebotomy will be carried out at 2 years (one month ahead or one month delayed could be accepted) after chemotherapy in both groups. AMH can be measured on any day during the menstrual cycle.Serum AMH concentrations will be measured using the AMH Gen II ELISA, according to the manufacturer's instructions
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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