Status:
ACTIVE_NOT_RECRUITING
Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination ch...
Detailed Description
OBJECTIVES: Primary * Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide \[TAC\] vs doxorubicin and cyclophosphamide followed by paclitaxel and c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven infiltrating ductal or lobular breast carcinoma
- Stage II or III disease
- Inflammatory breast cancer allowed
- Hormone-receptor status not specified
- PATIENT CHARACTERISTICS:
- ECOG performance status \< 2
- Male or female
- Menopausal status not specified (for female patients)
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal (except for patient's with Gilbert's disease)
- Creatinine ≤ 1.2 mg/dL
- Creatinine clearance ≥ 70 mL/min
- Ejection fraction ≥ 50% on MUGA
- No neuropathy ≥ grade 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No prior malignant disease within the past 5 years, excluding:
- Squamous cell or basal cell skin carcinoma
- Stage I or in situ cervical carcinoma
- No noninvasive (in situ) breast carcinoma within the past 5 years
- PRIOR CONCURRENT THERAPY:
- At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
- No prior radiotherapy to the chest wall
Exclusion
Key Trial Info
Start Date :
September 27 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2026
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00295893
Start Date
September 27 2005
End Date
August 11 2026
Last Update
September 25 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000