Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005908
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2000-06-13
Brief Title:
Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Trial of Sequential Primary Neoadjuvant Combination Chemotherapy With DocetaxelCapecitabine TX and DoxorubicinCyclophosphamide AC in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression
Status:
COMPLETED
Status Verified Date:
2013-03
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:
None
Brief Summary:
This study will assess the usefulness of a technique called complementary deoxyribonucleic acid cDNA microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients The study will look for markers that can help select the most effective type of chemotherapy It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel
Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study Those enrolled will be treated with surgery standard chemotherapy using doxorubicin Adriamycin and cyclophosphamide Cytoxan and the capecitabine and docetaxel combination
Patients will have a physical examination mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment They will then have four 21-day treatment cycles of docetaxel and capecitabine as follows docetaxel intravenously through a vein on day 1 and capecitabine pills by mouth twice a day from days 2 through 15 No drugs will be given from days 16 through 21 This regimen will be repeated four times after which the tumor will be re-evaluated by physical examination mammogram and magnetic resonance imaging
Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes mastectomy and removal of the underarm lymph nodes or modified radical mastectomy After recovery they will have four more cycles of chemotherapy this time with a doxorubicin and cyclophosphamide Both drugs will be given intravenously on day 1 of four 21-day cycles
Some patients who had a mastectomy depending on their tumor characteristics and whether tumor cells were found in their lymph nodes and all those who had a lumpectomy will also have radiation therapy Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years
In addition to the above procedures all patients will have tumor biopsies removal of a small piece of tumor tissue before beginning treatment on day 1 of cycle 1 before cycle 2 and at the time of surgery and physical examinations chest X-rays bone scans computerized tomography CT scans electrocardiograms multi-gated acquisition scan-MUGA nuclear medicine test of cardiac function or echocardiograms of heart function mammograms and blood tests at various times during the study Patients will be followed at National Institutes of Health NIH for 3 years after diagnosis with physical examinations blood tests X-rays and computed tomography CT scans
Although it is not known whether this treatment will help an individual patients cancer possible benefits are tumor shrinkage and decreased risk of disease recurrence In addition the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted
Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study Those enrolled will be treated with surgery standard chemotherapy using doxorubicin Adriamycin and cyclophosphamide Cytoxan and the capecitabine and docetaxel combination
Patients will have a physical examination mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment They will then have four 21-day treatment cycles of docetaxel and capecitabine as follows docetaxel intravenously through a vein on day 1 and capecitabine pills by mouth twice a day from days 2 through 15 No drugs will be given from days 16 through 21 This regimen will be repeated four times after which the tumor will be re-evaluated by physical examination mammogram and magnetic resonance imaging
Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes mastectomy and removal of the underarm lymph nodes or modified radical mastectomy After recovery they will have four more cycles of chemotherapy this time with a doxorubicin and cyclophosphamide Both drugs will be given intravenously on day 1 of four 21-day cycles
Some patients who had a mastectomy depending on their tumor characteristics and whether tumor cells were found in their lymph nodes and all those who had a lumpectomy will also have radiation therapy Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years
In addition to the above procedures all patients will have tumor biopsies removal of a small piece of tumor tissue before beginning treatment on day 1 of cycle 1 before cycle 2 and at the time of surgery and physical examinations chest X-rays bone scans computerized tomography CT scans electrocardiograms multi-gated acquisition scan-MUGA nuclear medicine test of cardiac function or echocardiograms of heart function mammograms and blood tests at various times during the study Patients will be followed at National Institutes of Health NIH for 3 years after diagnosis with physical examinations blood tests X-rays and computed tomography CT scans
Although it is not known whether this treatment will help an individual patients cancer possible benefits are tumor shrinkage and decreased risk of disease recurrence In addition the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted
Detailed Description:
This phase II trial in patients with stage II and stage III breast cancer will test the feasibility of using cDNA microarray as a measure of a tumors biological response to chemotherapeutic agents by characterizing the cDNA expression patterns in breast cancer before and after primary chemotherapy Thirty-six patients receive docetaxelcapecitabine induction chemotherapy followed by surgery and doxorubicincyclophosphamide adjuvant therapy TXAC We will determine the response rate of TX induction therapy and the toxicities of the sequential combinations TXAC We will also obtain tumor tissue for correlative biological determinations
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 |
|---|---|---|---|
| 00-C-0149 | None | None | None |