Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251329
Status:
UNKNOWN
Last Update Posted:
2007-04-04
First Post:
2005-11-08
Brief Title:
Docetaxel Carboplatin and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery
Sponsor:
Cancer Research Network
Organization:
Cancer Research Network
Study Overview
Official Title:
Phase II Neoadjuvant Trial of Docetaxel Taxotere Carboplatin and Capecitabine Xeloda in the Treatment of Early Stage Locally Advanced and Inflammatory Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response PCR Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery If chemotherapy given before breast surgery is effective in decreasing the size of the tumor breast conserving surgery lumpectomy may be possible This new combination may be better tolerated than other commonly used regimens and to date appears to be at least as effective
Detailed Description:
Neoadjuvant primary chemotherapy is being used more frequently in locally advanced breast cancer in an effort to reduce the size of the primary tumor prior to surgery and to eliminate micrometastatic diseaseThrough previous studies it has been shown that patients who receive neoadjuvant therapy demonstrate prolonged disease-free survival when compared to those who did not have a pCR at the time of surgery
It is proven that docetaxel is the single most active drug in metastatic breast cancer treatment and therefore has sparked interest in its use in the neoadjuvant setting There have been studies conducted using docetaxel either alone or in combination in this setting and in one particular study showed that patients treated with docetaxel after an anthracycline -containing regimen achieved at 34 pCR compared to only 16 with the anthracycline-containing regimen alone This drugs low incidence of neutropenia when administered on a weekly schedule plus its possible synergistic effects with carboplatin and capecitabine lead to its inclusion in this neoadjuvant protocol
Carboplatin is an agent that has recently been integrated into the front line of breast cancer treatment due to its response rate and tolerability This drug as well has warranted further investigation in the neoadjuvant setting and was combined with docetaxel in one trial for for locally advanced disease which showed a preliminary pCR of the breast and axilla of 30 and 80 respectively Due to its tolerability minimal toxicities and impressive results as a single agent and in combination with docetaxel made carboplatin a reasonable drug of choice in this study
The novel oral agent capecitabine is being used in this protocol because it has shown through study to significantly increase response rate time to progression and even overall survival when combined with docetaxel in the metastatic setting As well capecitabine behaves similarly to continuous 5-FU infusion which has shown success in several phase II neoadjuvant trials and essentially has led to its inclusion in this study Capecitabines anti-tumor activity coupled with ease of administration potential synergism with docetaxel and carboplatin and non-overlapping toxicities justifies its inclusion in this investigational regimen
It is proven that docetaxel is the single most active drug in metastatic breast cancer treatment and therefore has sparked interest in its use in the neoadjuvant setting There have been studies conducted using docetaxel either alone or in combination in this setting and in one particular study showed that patients treated with docetaxel after an anthracycline -containing regimen achieved at 34 pCR compared to only 16 with the anthracycline-containing regimen alone This drugs low incidence of neutropenia when administered on a weekly schedule plus its possible synergistic effects with carboplatin and capecitabine lead to its inclusion in this neoadjuvant protocol
Carboplatin is an agent that has recently been integrated into the front line of breast cancer treatment due to its response rate and tolerability This drug as well has warranted further investigation in the neoadjuvant setting and was combined with docetaxel in one trial for for locally advanced disease which showed a preliminary pCR of the breast and axilla of 30 and 80 respectively Due to its tolerability minimal toxicities and impressive results as a single agent and in combination with docetaxel made carboplatin a reasonable drug of choice in this study
The novel oral agent capecitabine is being used in this protocol because it has shown through study to significantly increase response rate time to progression and even overall survival when combined with docetaxel in the metastatic setting As well capecitabine behaves similarly to continuous 5-FU infusion which has shown success in several phase II neoadjuvant trials and essentially has led to its inclusion in this study Capecitabines anti-tumor activity coupled with ease of administration potential synergism with docetaxel and carboplatin and non-overlapping toxicities justifies its inclusion in this investigational regimen
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