Status:
COMPLETED
Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Pharmacia
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs...
Detailed Description
OBJECTIVES: * Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel, in terms of the absence of any grade 3 or higher toxicity (aside from alope...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Stage I, II, or III
- Inflammatory breast cancer allowed
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hepatic
- Bilirubin normal
- SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) AND alkaline phosphatase no greater than ULN OR
- SGOT/SGPT no greater than ULN AND alkaline phosphatase no greater than 4 times ULN
- Renal
- Not specified
- Cardiovascular
- LVEF at least lower limit of normal by MUGA or echocardiogram
- No unstable angina
- No congestive heart failure
- No arrhythmia requiring medical therapy
- No myocardial infarction within the past year
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergy/hypersensitivity to any of the study drugs or other drugs formulated with Cremophor EL
- No psychiatric illness that would preclude understanding of the nature of the study or study compliance
- No active unresolved infection
- No peripheral neuropathy greater than grade 1
- No other nonmammary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No concurrent medical condition that would preclude study participation in the judgment of the investigator
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 12 months since prior immunotherapy for prior breast cancer
- No prior or concurrent biologic therapy or immunotherapy for this breast cancer
- Chemotherapy
- More than 12 months since prior chemotherapy for prior breast cancer
- No prior anthracycline (i.e., doxorubicin or epirubicin) and taxane therapy
- No prior or other concurrent chemotherapy for this breast cancer
- Endocrine therapy
- No concurrent hormonal therapy for chemoprevention
- Prior hormonal therapy for chemoprevention allowed
- No concurrent sex hormonal therapy (e.g., birth control pills or ovarian hormonal replacement therapy)
- Radiotherapy
- No prior radiotherapy
- No other concurrent radiotherapy for this breast cancer
- Surgery
- Not specified
- Other
- No concurrent digitalis, beta-blockers, or calcium channel blockers for congestive heart failure
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072319
Start Date
August 1 2003
End Date
November 1 2006
Last Update
March 4 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021