Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080626
Status:
TERMINATED
Last Update Posted:
2019-03-21
First Post:
2004-04-07
Brief Title:
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
PURPOSE This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer
Detailed 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- andor 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
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- andor 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
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 |
|---|---|---|---|
| CDR0000346460 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA006973 |
| P50CA088843 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| NA_00040559 | OTHER | None | None |
| JHOC-03012301 | OTHER | None | None |
| JHOC-J0266 | OTHER | None | None |