Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206518
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2005-09-14
Brief Title:
Taxotere and AdriamycinCytoxan AC Validation in Breast Cancer Patients
Sponsor:
Mothaffar Rimawi
Organization:
Baylor Breast Care Center
Study Overview
Official Title:
A Randomized Multicenter Trial of Neoadjuvant Taxotere T and AdriamycinCytoxan Ac A Validation
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACAC
Brief Summary:
The purpose of this study is to learn if the biomarker information obtained learned or received from the earlier studies can tell us whether or not Taxotere andor AdriamycinCytoxan can cause tumors to become smaller
Detailed Description:
Large clinical trials have confirmed the value of systemic adjuvant therapy in decreasing the risk of recurrence and death in patients with early breast cancer However the need to identify breast cancer patients who will benefit from adjuvant therapy while sparing others from the side effects of futile treatment is spurring research into predictive markers of chemotherapy sensitivity and resistance In the adjuvant setting extremely large trials and long follow-up would be required to prospectively validate the predictive value of biomarkers of chemotherapy sensitivity or resistance In part this is because response is not directly observable Preoperative chemotherapy for large tumors 3cm or inoperable breast cancer is well established and is the standard of care for locally advanced breast cancer Data from large series of patients have demonstrated that preoperative neoadjuvant chemotherapy leads to significant reduction of tumor size downstaging and improves both the rate and the cosmetic results of breast- conserving surgery The degree of response to neoadjuvant therapy has been shown to predict improved overall survival This is therefore an attractive setting to study predictors of response because tissue is accessible from pre- therapeutic biopsies and tumor response is directly observable
In an early proof-of-principle pilot study of single agent neoadjuvant docetaxol we identified a predictive gene expression pattern and using leave-one-cross validation a method of internal validation we demonstrated that the pattern was likely to accurately discriminate between responders and non-responders Chang JC et al Gene expression profiling for the prediction of therapeutic response to docetaxel in patients with breast cancer Lancet 2003 3629381 p 362-9 A similar pilot study of neoadjuvant AC undertaken by a collaborator in the UK suggests that different profiles will be predictive for AC response
In order to definitively determine predictive patterns for both regimens T and AC using improved technology for RNA preparation and a larger more comprehensive gene expression array we undertook a randomized Phase II trial of these two widely used regimens Protocol H-11624 - A RANDOMIZED MULTICENTER TRIAL OF NEOADJUVANT TAXOTERE AND ADRIAMYCINCYTOXAN AC A BIOLOGIC CORRELATIVE STUDY The trial is nearing completion having recruited more than 90 patients out of an expected 120 patients To date the risks associated with this study have been modest and there have been no unexpected adverse events The laboratory work is well underway and gives every indication that clinically useful classifiers to predict treatment efficacy will result
In an early proof-of-principle pilot study of single agent neoadjuvant docetaxol we identified a predictive gene expression pattern and using leave-one-cross validation a method of internal validation we demonstrated that the pattern was likely to accurately discriminate between responders and non-responders Chang JC et al Gene expression profiling for the prediction of therapeutic response to docetaxel in patients with breast cancer Lancet 2003 3629381 p 362-9 A similar pilot study of neoadjuvant AC undertaken by a collaborator in the UK suggests that different profiles will be predictive for AC response
In order to definitively determine predictive patterns for both regimens T and AC using improved technology for RNA preparation and a larger more comprehensive gene expression array we undertook a randomized Phase II trial of these two widely used regimens Protocol H-11624 - A RANDOMIZED MULTICENTER TRIAL OF NEOADJUVANT TAXOTERE AND ADRIAMYCINCYTOXAN AC A BIOLOGIC CORRELATIVE STUDY The trial is nearing completion having recruited more than 90 patients out of an expected 120 patients To date the risks associated with this study have been modest and there have been no unexpected adverse events The laboratory work is well underway and gives every indication that clinically useful classifiers to predict treatment efficacy will result
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