Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Vered Stearns

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00080626
Information obtained from ClinicalTrials.gov on January 18, 2012

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