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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00001250 |
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Date of registration:
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03/11/1999 |
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Primary sponsor: |
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Public title:
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Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial
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Scientific title:
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Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial |
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Date of first enrolment:
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December 1989 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001250 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA
Women of any age with clinical stage II breast cancer who met the following criteria:
Patients with stage II breast cancer will include primary tumor less than or equal to 5 cm
in size with axillary lymph nodes which are clinically ([N0 or N1] [T1N1, T2N0, T2N1]).
Patients will be staged according to the 1986 AJCC TMM classification.
Patients with bilateral breast cancer will be eligible provided at least one tumor is
invasive and classified as stage I or II, and neither breast is stage III.
Histologic sections of the breast tumor must be classified as an invasive primary breast
neoplasm of epithelial origin.
Patients must be geographically accessible for follow-up and willing to return for the
follow-up at the NCI.
Patients must be mentally competent to understand and give informed consent for the
protocol.
Estrogen receptor (ER) status can include ER positive, negative, or unknown.
Patients with prior cancers may be eligible as long as they have received curative therapy
and have had no evidence of recurrence for greater than or equal to 10 years.
EXCLUSION CRITERIA
Patients will be excluded from this protocol for the following reasons:
Advanced local disease or distant metastases (stage III or IV).
Previous therapy to the breast other than excisional biopsy.
Pregnancy.
Unwillingness to use birth control during chemotherapy.
Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may
render the patient a poor risk for surgery or chemotherapy. Specifically, liver function
- SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper
limits of normal. Renal function - creatinine should be less than 1.7 and/or creatinine
clearance should be greater than 45 ml/min. If there is any history of cardiac disease,
patients must have a normal ejection fraction on MUGA scan and no angina.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasm
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Neoplasm Metastasis
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Intervention(s)
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Drug: preoperative dose intense chemotherapy (FLAC/G-CSF)
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Secondary ID(s)
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90-C-0044
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900044
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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