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

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00253500

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: epirubicin hydrochloride Drug: pegfilgrastim Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Epirubicin hydrochloride Epirubicin Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete pathological response rate by tumor analysis after surgery [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks [ Designated as safety issue: No ]
Toxicity by physical exam and medical history every 14 days prior to surgery [ Designated as safety issue: Yes ]
Predictive value of HER2 gene amplification and topoisomerase II-alpha gene amplification or deletions for pathologic complete response, clinical complete response or disease progression after surgery [ Designated as safety issue: No ]
Gene expression after surgery [ Designated as safety issue: No ]

Study Start Date:	June 2002
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253500

Locations

United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

George T. Budd, MD

The Cleveland Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000446099, CASE-CCF-4907, CWRU-3104
Study First Received:	November 11, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00253500
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage I breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009