Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

NCT ID: NCT00253500

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2010-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are undergoing surgery for stage I, stage II, or stage III breast cancer.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epirubicin

Group Type: EXPERIMENTAL

pegfilgrastim

Intervention Type: BIOLOGICAL

6 mg in a syringe

epirubicin hydrochloride

Intervention Type: DRUG

120 MG q 2 weeks for 4 cycles

conventional surgery

Intervention Type: PROCEDURE

to remove small piece of cancer

Interventions

pegfilgrastim

6 mg in a syringe

Intervention Type: BIOLOGICAL

epirubicin hydrochloride

120 MG q 2 weeks for 4 cycles

Intervention Type: DRUG

conventional surgery

to remove small piece of cancer

Intervention Type: PROCEDURE

Other Intervention Names

Neulasta; Biopsy will involve a small surgical incision to remove a piece of the cancer.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George T. Budd, MD

Role: STUDY_CHAIR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Related Links

http://clinicaltrials.gov/ct2/results?term=case3104

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

CASE3104

Identifier Type: -

Identifier Source: org_study_id