Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer

NCT02483767 | Completed Phase 3 DMC

• 1 other identifier: PUMCH-BC-ovarian suppression
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a prospective randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). All patients are stratified according to age (\<35years vs.36-44years), hormone receptor status (HR+ or ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure, follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure.

Conditions

Breast Cancer

Keywords

Premenopausal Breast Cancer; Preservation of Ovarian Function; Gonadotropin-Releasing Hormone Agonist

Outcome Measures

Primary Outcomes (1)

• ovarian failure

  Ovarian failure is defined as amenorrhea for the preceding 6 months and follicle-stimulating hormone (FSH) and E2 levels in the post -menopausal range 2 year after the end of chemotherapy.

  2 years

Secondary Outcomes (5)

• Ovarian dysfunction

  1 year

• Time to the resumption of menstrual activity

  2 year

• pregnancy

  5 year

• DFS OS

  5 year

• FSH,E2,AMH

  2 year

Study Arms (2)

standard chemotherapy with goserelin

EXPERIMENTAL

standard chemotherapy with the GnRH agonist goserelin

Drug: goserelin; Drug: standard chemotherapy

standard chemotherapy without goserelin

ACTIVE COMPARATOR

standard chemotherapy without goserelin

Drug: standard chemotherapy

Interventions

goserelin DRUG

Gonadotropin-Releasing Hormone Agonist

Also known as: Gonadotropin-Releasing Hormone Agonist

standard chemotherapy with goserelin

standard chemotherapy DRUG

(Anthracyclines/cyclophosphamide) followed by paclitaxel or doxetaxel; doxetaxel/cyclophosphamide; doxetaxel or paclitaxel/Anthracyclines; fluorouraci/Anthracyclines/cyclophosphamide followed by doxetaxel or paclitaxel; doxetaxel/Anthracyclines/cyclophosphamide; Anthracyclines/cyclophosphamide;

Also known as: AC-P, TC, TA, TAC, FAC followed by T, AC

standard chemotherapy with goserelin; standard chemotherapy without goserelin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patients signed the written informed consent.
• Histologically proven stage I, II, or III breast cancer
• Must be candidates for adjuvant or neoadjuvant chemotherapy,
• Must be premenopausal.
• Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors.

You may not qualify if:

• The patients were previous chemotherapy;
• Evidence of distant metastases;
• Other malignancies in the previous 5 years.
• The patients were using GnRHa, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy.
• Pregnancy or lactation.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 17, 2017

Record last verified: 2017-10