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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253500
• Other study ID #: CASE3104
• Status: Completed
• Phase: Phase 2
• Start date: June 2002
• Est. completion date: December 2010

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• pegfilgrastim
6 mg in a syringe

Drug:
• epirubicin hydrochloride
120 MG q 2 weeks for 4 cycles

Procedure:
• conventional surgery
to remove small piece of cancer

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete pathological response rate by tumor analysis after surgery	No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.	4 weeks
Secondary	Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks	Bilateral (if both breasts are present) Mammograms (within 4 weeks of study entry)	4 weeks
Secondary	Toxicity by physical exam and medical history every 14 days prior to surgery	A physical exam Physical examination with recording of tumor size, if palpable.	2-4 weeks
Secondary	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	Patients whose tumors are positive for estrogen receptor (>1% staining by immunohistochemistry) or progesterone receptor (institutional definition) should receive post-operative hormonal therapy for 5 years.	5 years
Secondary	Gene expression after surgery	Patients whose tumors are positive for estrogen receptor (>1% staining by immunohistochemistry) or progesterone receptor (institutional definition) should receive post-operative hormonal therapy for 5 years.	5 years

External Links

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