Status:
UNKNOWN
Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer
Lead Sponsor:
Yonsei University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or...
Detailed Description
OBJECTIVES: Primary * Determine the rate of pathologic complete response in women with previously untreated stage II or III breast cancer treated with neoadjuvant doxorubicin hydrochloride and cyclo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive primary breast cancer
- Clinical (radiologic) stage II or III disease
- No T4d disease
- No inflammatory breast cancer
- ErbB2-negative disease OR patient cannot receive trastuzumab treatment
- ErbB2-positive disease defined as either immunohistochemistry 3+, or FISH- or CISH-positive; immunohistochemistry 2+ is to be determined according to FISH or CISH results
- PATIENT CHARACTERISTICS:
- Mobile
- ECOG performance status 0-1
- Normal cardiac function (LVEF \> 50%)
- Hemoglobin ≥ 10.0 g/dL
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 10 x 10\^4/μL
- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
- Total bilirubin ≤ 1.5 times ULN
- AST/ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow tablet whole with water
- No prior motor or sensory neurotoxicity CTCAE ≥ grade 2
- No other serious disease or medical condition
- No uncontrolled or serious cardiovascular disease, including any of the following:
- Myocardial infarction within the past 6 months
- New York Heart Association class III or IV heart failure
- Uncontrolled angina pectoris
- Clinically significant pericardial disease
- Cardiac amyloidosis
- No history of symptomatic or therapy-requiring cardiac arrhythmia CTCAE grade 3 (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation)
- No asymptomatic sustained ventricular tachycardia
- History of atrial fibrillation or cardiac arrhythmia controlled by medication allowed
- No uncontrolled infection, unstable peptic ulcer, uncontrolled diabetes, or any other contraindication to corticosteroid administration
- No history of infection or any other serious medical event which may cause any functional injury in the affected patient and consequently, interfere with continuing the study treatment
- No history of hypersensitivity to taxanes, fluorouracil, or S-1
- No significant gastrointestinal malfunction that will affect S-1 absorption
- No history of other cancer within the past 5 years except properly treated carcinoma in situ of the uterine cervix or basal cell or squamous cell carcinoma of the skin
- No severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
- No psychological, social, family, or geographical condition, or difficult circumstance that would preclude follow-up or compliance with the protocol
- PRIOR CONCURRENT THERAPY:
- No prior systemic treatment for this cancer (e.g., radiotherapy, chemotherapy, hormone therapy, or biological therapy)
- No prior preoperative topical treatments (e.g., incomplete surgery or radiotherapy) for this cancer
- No concurrent drug(s) that may potentially cause changes in the pharmacological activity of S-1 formulation, including any of the following:
- Allopurinol
- Phenytoin
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00994968
Start Date
July 1 2009
Last Update
October 29 2010
Active Locations (1)
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1
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea