Breast Cancer Clinical Trial
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
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.
Full Description
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Baltimore Maryland, 21231, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.