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: Phase II trial to study the effectiveness of neoadjuvant docetaxel in treating women who are undergoing surgery for breast cancer.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer	Drug: docetaxel  Drug: pegfilgrastim  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: conventional surgery  Procedure: cytokine therapy  Procedure: neoadjuvant therapy  Procedure: surgery	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer.

Secondary

• Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen.
• Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen.
• Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen.

OUTLINE: This is a pilot study.

• Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
• Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. Patients may receive additional chemotherapy prior to surgery at the discretion of the treating physician.
• Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician.
• Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician.
• Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician. Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

• At least 5 years

Hematopoietic

• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3

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

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-1000,  United States; Recruiting

Study chairs or principal investigators

Vered Stearns, MD,  Principal Investigator,  Sidney Kimmel Cancer Center   

Study ID Numbers:  CDR0000346460; JHOC-J0266; JHOC-03012301; NCT00080626
Record last reviewed:  May 2004
Last Updated:  December 6, 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00080626
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08