Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00427245
First received: January 25, 2007
Last updated: August 6, 2013
Last verified: May 2007

January 25, 2007
August 6, 2013
August 2004
Not Provided
Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
Rate of premature menopause, defined as menses stopping during a course of chemotherapy with no recovery for at least 12 months
Complete list of historical versions of study NCT00427245 on ClinicalTrials.gov Archive Site
  • Incidence of menopausal symptoms
  • Quality of life
  • Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
  • Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course 3, after course 6 or 8 (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to 5 years
  • Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
  • Incidence of pregnancy
  • Incidence of menopausal symptoms
  • Quality of life
  • Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
  • Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin and estradiol) as measured after course 3, after course 6 or 8 (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to 5 years
  • Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
  • Incidence of pregnancy
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Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]

RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.

OBJECTIVES:

Primary

  • Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .

Secondary

  • Compare the quality of life of patients treated with these regimens.
  • Compare menopausal symptoms in patients treated with these regimens.
  • Compare bone mineral density loss in patients treated with these regimens.
  • Compare hormone levels in patients treated with these regimens.
  • Compare menstruation in patients treated with these regimens.
  • Compare the incidence of pregnancy in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study. Patients are stratified according to age (≤ 40 years vs > 40 years) and participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide- and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy. Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.

Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually for up to 5 years.

After completion of study therapy, patients are followed periodically for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Infertility
  • Menopausal Symptoms
  • Drug: cyclophosphamide
  • Drug: goserelin acetate
  • Procedure: adjuvant therapy
  • Procedure: fertility assessment and management
  • Procedure: neoadjuvant therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer

    • Stages I-IIIB with node-positive or -negative disease (N0-2)
    • Operable disease
  • Must meet 1 of the following criteria:

    • Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
    • Scheduled to receive neoadjuvant chemotherapy
  • No metastatic breast cancer, including supraclavicular fossa metastases
  • Hormone receptor status meeting 1 of the following criteria:

    • Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy
    • ER positive AND no requirement for ovarian suppression as a necessary part of treatment

PATIENT CHARACTERISTICS:

  • Female
  • Premenopausal with regular menses in the 12 months preceding surgery
  • No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Suitable fitness status for chemotherapy
  • Adequate hepatic, renal, and bone marrow function
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or endocrine therapy
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00427245
CRUK-OPTION, CDR0000526368, EUDRACT-2004-000133-11, CRUK-BR0402, ISRCTN84856516, EU-20680
Not Provided
Not Provided
Anglo Celtic Cooperative Oncology Group
Not Provided
Study Chair: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP