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

Breast Cancer Clinical Trial

— POF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483767
• Other study ID #: PUMCH-BC-ovarian suppression
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2015
• Last updated: October 14, 2017
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• goserelin
Gonadotropin-Releasing Hormone Agonist
• standard chemotherapy
(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;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ovarian dysfunction	Ovarian dysfunction is defined as amenorrhea for the preceding 3 months and follicle-stimulating hormone (FSH) and E2 levels in the post -menopausal range 1 year or 2year after the end of chemotherapy.	1 year
Secondary	Time to the resumption of menstrual activity	Time to the resumption of menstrual activity will be assessed at 3month,1 year and 2year after the end of chemotherapy.	2 year
Secondary	pregnancy	whether pregnancy will be accessed at 1year, 2year, 3year, 4year, 5year after the end of chemotherapy	5 year
Secondary	DFS OS	Disease free survival (DFS) and overall survival (OS) will be assessed at 5years after the end of chemotherapy.	5 year
Secondary	FSH,E2,AMH	FSH, estradiol, and anti-Mullerian hormone (AMH) levels in the postmenopausal range will be assessed at 3month,1 year and 2year after the end of chemotherapy.	2 year