Completed

Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Breast Diseases
+2

+ Breast Neoplasms
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003Actual 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.

Official TitlePilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma 
NCT00072319
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases
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
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center
;