Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer - NCT00068601-08822 (Clinical Trial 117853)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy117853.aspx
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| City: |
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Flemington |
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State:
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NJ |
| Zip Code: |
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08822 |
| Conditions: |
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Breast Cancer - Menopausal Symptoms - Sexual Dysfunction and Infertility |
| Purpose: |
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RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether
ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women
receiving chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving goserelin together with
chemotherapy works compared with chemotherapy alone in preventing early menopause in women
with stage I, stage II, or stage IIIA breast cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare the rate of premature ovarian failure in women with stage I-IIIA hormone
receptor-negative breast cancer treated with chemotherapy with vs without goserelin.
Secondary
- Compare the rate of ovarian dysfunction in patients treated with these regimens.
- Compare ovarian reserve in patients treated with these regimens.
- Describe the pregnancy rates in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs
40 to 49) and planned chemotherapy regimen (3-month/4-course anthracycline-based vs 6- to
8-month/course anthracycline-based vs 6- to 8-month/course non-anthracycline-based).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week
before start of cyclophosphamide-containing chemotherapy. Treatment continues until
completion of chemotherapy in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are
followed at 1, 2, and 5 years.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this
study within 3 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Stage I-IIIA
- Operable disease
- Bilateral synchronous invasive breast cancer allowed provided primary tumors were
diagnosed no more than 1 month apart and both tumors are hormone receptor negative
- Must be planning to receive 3-8 months of a preoperative or postoperative
chemotherapy regimen containing alkylating agents (anthracyclines or
non-anthracyclines), meeting 1 of the following criteria:
- 3-month/4-course anthracycline-based regimen
- 6- to 8-month/course anthracycline-based regimen
- 6- to 8-month/course non-anthracycline-based regimen
- Hormone receptor status:
- Estrogen receptor negative
- Progesterone receptor negative
PATIENT CHARACTERISTICS:
Age
- 18 to 49
Sex
- Female
Menopausal status
- Premenopausal
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception
- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer or any in situ cancer from which the patient has been disease-free for at
least 5 years after treatment with curative intent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior cytotoxic chemotherapy
Endocrine therapy
- No other concurrent hormonal therapy
Radiotherapy
- Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed
Surgery
- See Disease Characteristics
Other
- Concurrent participation in other therapeutic clinical trials, including SWOG-S0221,
allowed |
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| Study is available at: |
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Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, NJ 08822
United States
Primary Contact:
Kenneth B. Blankstein, MD
Phone: 908-788-6100 |
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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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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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