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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 400
Study Start Date: August 2004
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427245

  Show 66 Study Locations
Sponsors and Collaborators
Anglo Celtic Cooperative Oncology Group
Investigators
Study Chair: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00427245     History of Changes
Other Study ID Numbers: CRUK-OPTION, CDR0000526368, EUDRACT-2004-000133-11, CRUK-BR0402, ISRCTN84856516, EU-20680
Study First Received: January 25, 2007
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
menopausal symptoms
infertility
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:
Breast Neoplasms
Infertility
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female
Cyclophosphamide
Goserelin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 18, 2014