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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Monica N. Fornier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-092

NCT ID:

NCT00072319

Start Date:

August 2003

Completion Date:

November 2006

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • inflammatory breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021