Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have stage III breast cancer.

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

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Aventis Pharmaceuticals; National Cancer Institute (NCI)
• Treatments: Docetaxel; Doxorubicin; Lenograstim; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or pathologically confirmed stage III breast cancer

• Clinical evidence of primary invasive breast tumor greater than 5 cm in dimension (T3) and no evidence of metastatic disease clinically or by staging studies including computed tomography (CT) scan of the chest, abdomen, and pelvis, and a bone scan

• Inflammatory breast carcinoma defined as diffuse brawny induration of the skin of the breast with an erysipeloid edge due to embolization of the dermal lymphatics and pathologic evidence of dermal lymphatic invasion

• No bilateral breast cancer unless synchronous

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,000/mm^3

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

Hepatic:

• Bilirubin less than 2.0 mg/dL

• SGOT/SGPT less than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 4 times ULN provided SGOT/SGPT no greater than ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• If prior cardiac event or ischemia on electrocardiogram, must be cleared by cardiologist

• LVEF at least 50% by resting MUGA

• No severe cardiac dysfunction

• No prior or concurrent angina pectoris, congestive heart failure, or major ventricular arrhythmias

• No uncontrolled essential hypertension

Other:

• Not pregnant or nursing

• Fertile patients must use effective nonhormonal barrier contraception

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma in situ of the breast

• No other serious medical or psychiatric illness that would preclude study consent or treatment

• No prior severe and intolerable reactions to filgrastim (G-CSF)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the breast

Surgery:

• Not specified