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Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer


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

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Trial Information

Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer


OBJECTIVES:

Primary

- Determine the complete pathological and clinical response rate in women undergoing
surgery for resectable stage I-III breast cancer treated with neoadjuvant
dose-intensified epirubicin hydrochloride.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the predictive value of HER2 gene amplification and topoisomerase II-alpha
gene amplification or deletion for disease progression and pathological and clinical
complete response in patients treated with this regimen.

- Correlate gene expression profiles with pathologic complete response, clinical complete
response, less than complete response, and disease progression in patients treated with
this regimen.

OUTLINE: Patients receive epirubicin hydrochloride IV on day 1 and pegfilgrastim
subcutaneously on day 2. Treatment repeats every 14 days for 4 courses in the absence of
disease progression or unacceptable toxicity. Four weeks later, patients undergo partial
mastectomy or simple mastectomy plus an axillary staging procedure.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive breast cancer

- Stage I, II, or III disease (T1, T2, or T4; N0-2; M0)

- Resectable disease

- Unidimensionally measurable disease

- Primary tumor ≥ 2 cm

- No known distant metastases

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Sex

- Female

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,500/mm^3

- Hemoglobin ≥ 8 g/dL

- Platelet count ≥ 100,000/mm^3

- No known untreated bleeding diathesis

Hepatic

- AST ≤ 2 times upper limits of normal

- Bilirubin ≤ 1.5 mg/dL

Renal

- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- LVEF ≥ 50% on echocardiogram, MUGA, or cardiac catheterization

Other

- Not pregnant or breastfeeding

- Fertile patients must use effective contraception

- Negative pregnancy test

- No concurrent illness that would preclude study treatment

- No known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim,
filgrastim (G-CSF), or any other component of these products

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathological response rate by tumor analysis after surgery

Outcome Description:

No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

George T. Budd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE3104

NCT ID:

NCT00253500

Start Date:

June 2002

Completion Date:

December 2010

Related Keywords:

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

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195