Study of Preservation of Ovarian Reserve During Chemotherapy for Young Breast Cancer Patients

NCT02430103 | Active Not Recruiting FDA Drug

• 1 other identifier: PKUPHBC-001
• Study Type: observational
• Target: 349
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Preservation of Ovarian Reserve Function; Goserelin; AMH

Outcome Measures

Primary Outcomes (1)

• Recovery of serum AMH value(≥0.5ng/ml) in 2 years of post-chemotherapy

  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

  Phlebotomy will be carried out at 2 years (one month ahead or one month delayed could be accepted) after chemotherapy in both groups.

Secondary Outcomes (1)

• Recovery of AFC (≥5) by ultrasound per vagina in 1 year and 2 years of post-chemotherapy

  AFC will be performed at 1 year and 2 years (one month ahead or one month delayed could be accepted) after chemotherapy in both groups.

Other Outcomes (7)

• Recovery of serum Follicle-Stimulating Hormone (FSH<25U/L) in 1 year and 2 years of post-chemotherapy

  Phlebotomy will be carried out at 1 year and 2 years (one month ahead or one month delayed could be accepted) after chemotherapy in both groups.

• Recovery of serum Estradiol (E2≥40pg/ml) in 1 year and 2 years of post-chemotherapy

  Phlebotomy will be carried out at 1 year and 2 years (one month ahead or one month delayed could be accepted) after chemotherapy in both groups.

• Recovery of serum AMH value(≥0.5ng/ml) in 1 year of post-chemotherapy

  Phlebotomy will be carried out at 1 year (one month ahead or one month delayed could be accepted) after chemotherapy in both groups.

Study Arms (2)

Chemotherapy plus GnRHa

Patients of the group will receive (neo)chemotherapy plus GnRHa ( 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).

Drug: Goserelin 3.6 MG

Chemotherapy

Patients of the group will receive (neo)chemotherapy merely.

Interventions

Goserelin 3.6 MG DRUG

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.

Also known as: Zoladex

Chemotherapy plus GnRHa

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

240 premenopausal breast cancer patients of age 45 years or younger treated in Peking University People's Hospital Breast Center

You may qualify if:

• Aged 45 years or younger
• Have regular menstrual cycle
• Newly diagnosed early-stage breast cancer (stages I to III)
• Planned (neo)adjuvant chemotherapy
• Signed informed consent document on file

You may not qualify if:

• Pregnancy or lactation
• Oral contraceptives before enrollment
• Prior chemotherapy
• Bilateral oophorectomy or ovarian irradiation before enrollment
• History of other cancers
• GnRHa -containing adjuvant endocrine therapy

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

• Wang S, Pei L, Hu T, Jia M, Wang S. Protective effect of goserelin on ovarian reserve during (neo)adjuvant chemotherapy in young breast cancer patients: a prospective cohort study in China. Hum Reprod. 2021 Mar 18;36(4):976-986. doi: 10.1093/humrep/deaa349.

  PMID: 33411897 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Shu Wang

  Peking University People's Hospital Breast Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nothing

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 30, 2015
• Study Start: December 25, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)