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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00253500
First received: November 11, 2005
Last updated: January 2, 2013
Last verified: January 2013
  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
Biological: pegfilgrastim
Drug: epirubicin hydrochloride
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Complete pathological response rate by tumor analysis after surgery [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.


Secondary Outcome Measures:
  • Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Bilateral (if both breasts are present) Mammograms (within 4 weeks of study entry)

  • Toxicity by physical exam and medical history every 14 days prior to surgery [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]
    A physical exam Physical examination with recording of tumor size, if palpable.

  • 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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Gene expression after surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: June 2002
Study Completion Date: December 2010
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epirubicin Biological: pegfilgrastim
6 mg in a syringe
Other Name: Neulasta
Drug: epirubicin hydrochloride
120 MG q 2 weeks for 4 cycles
Procedure: conventional surgery
to remove small piece of cancer
Other Name: Biopsy will involve a small surgical incision to remove a piece of the 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195-9001
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: George T. Budd, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00253500     History of Changes
Other Study ID Numbers: CASE3104, P30-CA43703
Study First Received: November 11, 2005
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
stage II breast cancer
stage I breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014