Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
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
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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
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 |
ClinicalTrials.gov processed this record on May 19, 2013