Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

• Status: Completed
• Trial end date: 2014-01-16
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Docetaxel; Epirubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria:

• T4, NX, M0

• Any T, N2-N3, M0

• Inflammatory breast cancer (redness over at least one-third of the breast), M0

• No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan

• Diagnosed within the past 8 weeks

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 16 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin less than upper limit of normal (ULN)

• Must meet criteria for 1 of the following:

• ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN

• ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• Resting LVEF normal by MUGA or echocardiogram

• No congestive heart failure

• No angina pectoris

• No myocardial infarction within the past year

• No uncontrolled hypertension

• No uncontrolled arrhythmias

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective non-hormonal contraception

• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

• No symptomatic peripheral neuropathy grade 2 or greater

• No active infection

• No history of significant neurological or psychiatric disorders, including dementia or seizures

• No peptic ulcer

• No unstable diabetes mellitus

• No contraindication to dexamethasone

• No known sensitivity to E. coli-derived or polyethylene glycol products

• Willing to undergo core biopsies once prior to registration and core biopsies at 2 other timepoints while on study

• Geographically accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy for breast cancer

Chemotherapy

• No prior chemotherapy for breast cancer

Endocrine therapy

• No prior hormonal therapy for breast cancer

• No concurrent corticosteroids except for premedication or hypersensitivity reaction

• No concurrent oral contraception

Radiotherapy

• No prior radiotherapy for breast cancer

Surgery

• No prior surgery for breast cancer other than biopsy

Other

• No prior systemic therapy for breast cancer

• No other concurrent investigational drugs or anticancer treatment

• No concurrent preventative IV antibiotics