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

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ClinicalTrials.gov Identifier: NCT02483767
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
gwcmc

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: goserelin Drug: standard chemotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Study Start Date : June 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: standard chemotherapy with goserelin
standard chemotherapy with the GnRH agonist goserelin
Drug: goserelin
Gonadotropin-Releasing Hormone Agonist
Other Name: Gonadotropin-Releasing Hormone Agonist

Drug: 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;
Other Names:
  • AC-P
  • TC
  • TA
  • TAC
  • FAC followed by T
  • AC

Active Comparator: standard chemotherapy without goserelin
standard chemotherapy without goserelin
Drug: 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;
Other Names:
  • AC-P
  • TC
  • TA
  • TAC
  • FAC followed by T
  • AC




Primary Outcome Measures :
  1. ovarian failure [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Ovarian dysfunction [ Time Frame: 1 year ]
    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.

  2. Time to the resumption of menstrual activity [ Time Frame: 2 year ]
    Time to the resumption of menstrual activity will be assessed at 3month,1 year and 2year after the end of chemotherapy.

  3. pregnancy [ Time Frame: 5 year ]
    whether pregnancy will be accessed at 1year, 2year, 3year, 4year, 5year after the end of chemotherapy

  4. DFS OS [ Time Frame: 5 year ]
    Disease free survival (DFS) and overall survival (OS) will be assessed at 5years after the end of chemotherapy.

  5. FSH,E2,AMH [ Time Frame: 2 year ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: gwcmc
ClinicalTrials.gov Identifier: NCT02483767     History of Changes
Other Study ID Numbers: PUMCH-BC-ovarian suppression
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by gwcmc:
Premenopausal Breast Cancer
Preservation of Ovarian Function
Gonadotropin-Releasing Hormone Agonist

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Goserelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents