Status:
COMPLETED
Docetaxel, Cisplatin and Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
Up to 65 years
Phase:
PHASE2
Brief Summary
The primary endpoint of this phase II trial is the objective response rate of the regimen. The secondary endpoints include treatment-related toxicity, progression free survival and overall survival an...
Detailed Description
This is an open-label phase II trial designed to test the effect and toxicity profile of combination of docetaxel, cisplatin, and capecitabine in locally advanced breast cancer patients.Breast cancer ...
Eligibility Criteria
Inclusion
- Women with histological proven LABC, without metastasis, and no prior therapy. LABC is defined as follows：
- Tumor more than 5 cm in diameter
- Tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
- Clinical evident inflammatory carcinoma
- Ipsilateral fixed axillary adenopathy
- Measurable disease by physical examination, breast sonography and other image study
- KPS≧ 70%
- Adequate bone marrow reserve, defined as white blood cell (WBC)≧ 3,500/ mm3, absolute neutrophil count (ANC)≧ 1,500/mm3, platelets ≧ 100,000/mm3
- Adequate liver and kidney function: total bilirubin ≦ 2.0 mg/dl, serum alanine transaminases (ALT) and aspartate transaminase (AST) ≦ 3 times upper normal limit, serum creatinine ≦ 1.5 mg/dl
- Patients must be ≦ 65 years old
- Signed informed consent
Exclusion
- Patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for LABC. Concomitant use of above therapy will no be allowed.
- Pregnant or lactating woman
- Metastases disease other than regional lymph node metastases (supraclavicular lymph node metastases is not eligible)
- Prior serious cardiac conditions such as angina, myocardial infarction, cardiomyopathy, severe cardiovascular disease or cardiac arrhythmias
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Secondary malignancy in past five years before entry of the study (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin)
- Active infection (at the discretion of the investigator)
- Significant neurological (such as seizures) or psychiatric disorder
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00155259
Start Date
October 1 2004
End Date
December 1 2006
Last Update
July 25 2007
Active Locations (1)
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1
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan