Overview

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