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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427245
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Infertility Menopausal Symptoms Drug: cyclophosphamide Drug: goserelin acetate Procedure: adjuvant therapy Procedure: fertility assessment and management Procedure: neoadjuvant therapy Phase 3

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]
Study Start Date : August 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months

Secondary Outcome Measures :
  1. Incidence of menopausal symptoms
  2. Quality of life
  3. Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
  4. 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
  5. Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
  6. Incidence of pregnancy

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • No prior chemotherapy or endocrine therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427245

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Sponsors and Collaborators
Anglo Celtic Cooperative Oncology Group
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Study Chair: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital

Layout table for additonal information Identifier: NCT00427245     History of Changes
Other Study ID Numbers: CRUK-OPTION
CDR0000526368 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
menopausal symptoms
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal