Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma
filgrastim
+ cyclophosphamide
+ epirubicin hydrochloride
Breast Diseases+4
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.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 alopecia), in women with high-risk stage I-III breast cancer. OUTLINE: This is a pilot study. Neoadjuvant or adjuvant EC therapy: Patients receive epirubicin IV over 3-5 minutes and cyclophosphamide IV (EC) on day 1 and filgrastim (G-CSF) subcutaneously on days 2-9 or 10. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity. Neoadjuvant or adjuvant paclitaxel therapy: After the completion of EC therapy, patients receive paclitaxel IV over 3 hours on day 1. Patients also receive G-CSF as in EC therapy. Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who have not had prior surgery undergo definitive surgery after the completion of chemotherapy. Patients also may receive adjuvant radiotherapy and/or hormonal therapy at the discretion of the treating physician. Patients are followed every 4 months for 3 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 11-38 patients will be accrued for this study within 1 year.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps