Status:
TERMINATED
Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. PU...
Detailed Description
OBJECTIVES: Primary * Pathologic complete response rate (pCR) of dose dense docetaxel in the neoadjuvant setting. Secondary * Safety and toxic effects of this regimen in these patients. * Tumor re...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Inclusion:
- Histologically or cytologically confirmed invasive carcinoma of the breast by core biopsy
- Tumor ≥ 2 cm in greatest dimension(may be either node positive or node negative disease
- Patients with non-metastatic breast cancer who are in the judgment of the treating medical oncologist considered to be of sufficiently high risk to warrant adjuvant chemotherapy
- Patients with internal mammary, supraclavicular and/or axillary node involvement are eligible. Patients with inflammatory breast cancer are eligible
- Patients with T0 disease but palpable and measurable adenopathy are eligible for this trial. All sites of disease should be noted and followed
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Menopausal status not specified
- Female ≥ 18 years old
- Absolute neutrophil count ≥ 1,000/mm\^3
- Hemoglobin ≥ 8 g/dL
- Platelet count ≥ 100,000/mm\^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:
- AP normal AND AST or ALT ≤ 5 times ULN
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Women of child-bearing potential, must have a negative serum pregnancy test and must use effective contraception for the duration of the study and for at least 6 months after completion of study treatment
- Patients with prior malignancies are eligible if they have been disease free for ≥ 5 years. Patients with curative treatment of non-melanomatous skin cancer, carcinoma in situ of the cervix, contralateral DCIS treated with mastectomy are eligible even if it is diagnosed in \< 5 years.
- PRIOR CONCURRENT THERAPY:
- No prior anthracycline or taxane-based chemotherapy. Patients who received chemoprevention are eligible if the chemopreventive agent has been discontinued for at least one year prior to enrollment in the current study.
- At least 1 year since prior tamoxifen for breast cancer prevention
- Exclusion:
- Prior radiotherapy to the ipsilateral breast
- Patients who have had radiation to the contralateral breast are eligible
- Evidence of distant metastatic disease (i.e., lung, liver, bone, brain)
- Pregnant of breastfeeding
- Patients who have congestive heart failure, angina pectoris, uncontrolled cardiac arrhythmia, or other significant heart disease, or who have had a myocardial infarction within the past year
- Patients with \> grade 1 peripheral neuropathy
- Patients with a history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
- Patients receiving an investigational anticancer drug within 3 weeks of registration
- Patients with serious medical illness that in the judgment of the treating physician, places the patient at risk.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00343512
Start Date
February 1 2004
End Date
March 1 2011
Last Update
April 27 2012
Active Locations (2)
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1
Meharry Medical College
Nashville, Tennessee, United States, 37208
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838