Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01229605
Status:
WITHDRAWN
Last Update Posted:
2011-12-12
First Post:
2010-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer
Sponsor:
Tufts Medical Center
Organization:
Study Overview
Official Title:
Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer, A Collaborative Trial
Status:
WITHDRAWN
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not a good fit for the patient population seen at this hospital.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The standard therapy for patients who have locally advanced breast cancer is to receive chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy (NAC). Chemotherapy is used to shrink the tumor before surgery, which sometimes may allow for a smaller portion of the breast to be removed. Receiving chemotherapy before surgery may sometimes also allow for smaller portions of the breast to be removed. Getting chemotherapy prior to surgery may also control any hidden metastatic disease and thereby decrease the risk of cancer relapse. Pre-surgery chemotherapy is a standard management approach for locally advanced breast cancer.
Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The purpose of this study is to determine if using a chemotherapy regimen of TC is effective way to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before surgery. The investigators also hope this study will help us to better understand how the tumor tissue is affected by this combination of chemotherapy drugs.
The TC drug combination is FDA approved for use in treating breast cancer, and it has been shown to be equally effective as other commonly used chemotherapy regimens when used after surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for use before surgery. The investigators will be studying the combination of TC used before surgery as a means of possibly shrinking the tumor.
Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The purpose of this study is to determine if using a chemotherapy regimen of TC is effective way to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before surgery. The investigators also hope this study will help us to better understand how the tumor tissue is affected by this combination of chemotherapy drugs.
The TC drug combination is FDA approved for use in treating breast cancer, and it has been shown to be equally effective as other commonly used chemotherapy regimens when used after surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for use before surgery. The investigators will be studying the combination of TC used before surgery as a means of possibly shrinking the tumor.
Detailed Description:
This is a single-arm, open-label phase II study of cyclophosphamide and docetaxel/taxotere (TC) every 3 weeks in Her2 (-) subjects with locally advanced breast cancer. It is designed to assess (1) the clinical and pathologic response rates to this regimen, as well as its tolerability in this subject population, and (2) the expression of Tiam1 in tumor-associated fibroblasts pre and post treatment.
Study Oversight
Has Oversight DMC:
False
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?: