Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

• Status: Terminated
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed infiltrating carcinoma of the breast

• Unresected clinical stage T1c, T2, T3, or T4 lesion, any N

• Newly diagnosed disease

• Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry

• Mammogram of the contralateral breast within 6 months before study entry

• Clinically measurable disease

• Hormone receptor status:

• Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

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

• Hemoglobin at least 8 g/dL

Hepatic

• Bilirubin no greater than 1.5 times normal

Renal

• Creatinine no greater than 1.5 times normal

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for current breast cancer

Endocrine therapy

• At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention

• No prior endocrine therapy for current breast cancer

Radiotherapy

• No prior radiotherapy for current breast cancer

Surgery

• Not specified