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NCT Number: NCT02483767

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goserelin

Drug

Gonadotropin-Releasing Hormone Agonist

Other names: Gonadotropin-Releasing Hormone Agonist

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;

Other names: AC-P, TC, TA, TAC, FAC followed by T, AC

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Acronym: POF

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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