Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer - NCT00427245-Dunfermline - 0054(Clinical Trial 161045)
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Dunfermline |
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Country:
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United Kingdom |
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| Conditions: |
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Breast Cancer - Menopausal Symptoms - Sexual Dysfunction and Infertility |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
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