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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: |
NCT00148720 |
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Date of registration:
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07/09/2005 |
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Primary sponsor: |
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Public title:
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Capecitabine in Women With Operable Breast Cancer
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Scientific title:
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A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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80 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00148720 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ian Krop, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber Cancer Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histological confirmation of primary invasive breast cancer
- Stage I-III operable breast cancer.
- Primary tumor must be greater than or equal to 2cm by radiographic imaging or
palpitation
- Women greater than 18 years of age
- ECOG performance status 0-1
- WBC > 4000/mm3
- Platelet count > 100,000/mm3
- SGOT < 2x ULN
- Calculated creatinine clearance > 50ml/min
Exclusion Criteria:
- Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study.
- Pregnant or breast-feeding women
- Inflammatory breast cancer
- HER2 positive disease
- History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD)
deficiency
- Uncontrolled intercurrent illness
- Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago;
present cancer is not in previously irradiated breast; no prior chemotherapy in the
past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow
transplant.
- Excisional biopsy performed prior to enrollment
- Uncontrolled coagulopathy
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer Invasive Nos
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Breast Cancer Stage II
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Breast Cancer Stage III
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Primary Invasive Breast Cancer
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Stage I Breast Cancer
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Intervention(s)
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Drug: Capecitabine
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Primary Outcome(s)
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To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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