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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epirubicin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegfilgrastim | Biological | 6 mg in a syringe |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Toxicity by physical exam and medical history every 14 days prior to surgery |
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DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Stage I, II, or III disease (T1, T2, or T4; N0-2; M0)
Unidimensionally measurable disease
No known distant metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Not specified
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| Name | Affiliation | Role |
|---|---|---|
| George T. Budd, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195-9001 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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| epirubicin hydrochloride | Drug | 120 MG q 2 weeks for 4 cycles |
|
| conventional surgery | Procedure | to remove small piece of cancer |
|
|
A physical exam Physical examination with recording of tumor size, if palpable. |
| 2-4 weeks |
| 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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |