Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00072319|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : March 4, 2013
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 before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells.
PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: filgrastim Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: paclitaxel Procedure: adjuvant therapy Procedure: neoadjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma|
|Study Start Date :||August 2003|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072319
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Monica N. Fornier, MD||Memorial Sloan Kettering Cancer Center|