Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343512
Status:
TERMINATED
Last Update Posted:
2012-04-27
First Post:
2006-06-22
Brief Title:
Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage IIIII Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
closed due to competing neoadjuvant studies for a small patient population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Dose-dense scheduling with pegfilgrastim 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 pegfilgrastim 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
PURPOSE To evaluate whether dose-dense scheduling with pegfilgrastim 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
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 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 andor 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
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 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VICC-BRE-0368 | None | None | None |
| VICC-11239 | None | None | None |