Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00343512|
Recruitment Status : Terminated (closed due to competing neoadjuvant studies for a small patient population)
First Posted : June 23, 2006
Results First Posted : November 9, 2010
Last Update Posted : April 27, 2012
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.
PURPOSE: To evaluate whether 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. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel Genetic: protein expression analysis Other: laboratory biomarker analysis Procedure: biopsy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
- Pathologic complete response rate (pCR) of dose dense docetaxel in the neoadjuvant setting.
- Safety and toxic effects of this regimen in these patients.
- Tumor response rate (as measured by ultrasound) in patients treated with this regimen.
- Determine whether early changes in markers of cell cycle position, proliferation, or apoptosis correlate with pathologic complete response rate in these patients.
- Determine whether the molecular profile that predicts for chemoresponsiveness also predicts for response to radiotherapy (as measured by local recurrence) in these patients.
- Determine whether tumors that demonstrate the greatest degree of change in protein expression patterns from pre- to post-docetaxel treatment will also be those that are most sensitive to chemotherapy (as measured by pathologic response rate) in these patients.
OUTLINE: This is a nonrandomized, open-label, pilot study.
- Tissue Collection: Patients undergo tumor core biopsy (6-8 cores) and blood collection prior to initiating neoadjuvant docetaxel.
- Neoadjuvant docetaxel with hematopoietic support: Patients receive docetaxel IV over 1 hour on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 or 2 of each course OR filgrastim (G-CSF) or sargramostim (GM-CSF) SC daily beginning between day 2-4 of each course and continuing until blood counts recover. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Surgery: Within 4-6 weeks after completion of neoadjuvant docetaxel, patients undergo definitive surgery.
Patients undergo tumor biopsy and blood collection periodically for pharmacokinetic, genetic, and molecular biomarker correlative studies. Samples are examined for changes in p21 protein expression (and/or p21 phosphorylation) and the protein expression profile.
After completion of study treatment, patients are followed at least every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage II/III Breast Cancer|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2011|
|Experimental: Therapeutic Intervention||
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
Other Name: Taxotere
Genetic: protein expression analysis
protein expression analysis
Other: laboratory biomarker analysis
laboratory biomarker analysis
Procedure: conventional surgery
Procedure: neoadjuvant therapy
- Number Participants to Achieve Pathologic Complete Response [ Time Frame: 3 month ]whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)
- Safety Profile Based on Number of Patients With Each Worst-grade Toxicity [ Time Frame: Through 30 days after completion of treatment ]Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria
- Tumor Response as Measured by Ultrasound [ Time Frame: At screening, 8 weeks and at surgery (within 14-21 days) ]Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343512
|United States, Tennessee|
|Meharry Medical College|
|Nashville, Tennessee, United States, 37208|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||A. Bapsi Chakravarthy, MD||Vanderbilt-Ingram Cancer Center|