Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050167
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2002-11-25
Brief Title:
Evaluation of Differing TaxanesTaxane Combinations on the Outcome of Patients With Operable Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of Differing TaxanesTaxane Combinations on the Outcome of Patients With Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-08
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:
Primary Objectives
Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer
Determine the ability of docetaxelcapecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel
Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting See protocol text for additional objectives and details
Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer
Determine the ability of docetaxelcapecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel
Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting See protocol text for additional objectives and details
Detailed Description:
Before the study participants will have a complete physical exam including blood tests and a chest x-ray A mammogram and a sonogram of the breast and armpit will be done to record tumor size for patients who have not had surgery Sonography of the liver or a CT scan of the abdomen will also be done In some patients who have not had surgery 3-4 samples of the breast tumor will be taken to help confirm the diagnosis of breast cancer A biopsy needle will be used to collect the samples
During the study participants will have blood tests done before each dose of chemotherapy For participants who have not had surgery a mammogram and sonogram will be done of the breast and armpit after completion of paclitaxel or docetaxelcapecitabine and after completion of fluorouracil cyclophosphamide and epirubicin FEC These studies will help doctors to keep track of the tumor size and help with the final decision whether to remove all or part of the breast and nearby lymph nodes after completion of chemotherapy
Participants in this study will be randomly assigned as in the toss of a coin to one of two treatment groups There is an equal chance of being in either group
Participants in Group I will receive paclitaxel once a week The drug will be given through a plastic tube in a vein over 1 hour for a total of 12 treatments Before each treatment patients will receive the drug Decadron dexamethasone through the vein and may receive Zofran ondansetron Benadryl diphenhydramine hydrochloride andor cimetidine to help decrease the risk of side effects from paclitaxel
Participants in Group II will receive docetaxel and capecitabine Docetaxel will be given once every 3 weeks Docetaxel will be given through a plastic tube in the vein over 1 hour Capecitabine will be started the same day docetaxel is given This medicine is given in a pill form The doctor will prescribe a dose of these pills based upon body weight and height Participants will take several pills two times a day for 14 days Participants will then not take any capecitabine pills for one week until the next dose of docetaxel is given This combination of docetaxel and capecitabine will be given four times over a period of 12 weeks Before each treatment patients will receive the drug Decadron dexamethasone by mouth
After treatment with either paclitaxel or docetaxelcapecitabine all participants will receive the drugs FEC through a plastic tube into a vein All of these drugs will be given once every three weeks for a total of 4 treatments 12 weeks total Decadron dexamethasone Zofran ondansetron and Benadryl diphenhydramine hydrochloride will be given before the chemotherapy to help decrease the risk of side effects
Participants who have a Her-2neu positive cancer will potentially be eligible to receive trastuzumab therapy for 1 year This medicine is given through a vein either once a week over 30 minutes or once every 3 weeks over 30 minutes Your doctor will discuss whether this medicine is appropriate for you
After all treatment is done participants whose tumors are sensitive to hormones estrogen will take a pill to help decrease the amount of hormone estrogen that can reach any tumor cells This pill will be taken once a day for 5 years
Participants who have not completed surgery for their cancer before receiving the chemotherapy described above will have surgery to remove all or part of the breast that has cancer If there are signs that the lymph nodes in the armpit axilla contain cancer these lymph nodes will also be removed
After chemotherapy and surgery or after completion of chemotherapy patients who had surgery done first participants may then receive radiation treatment to the breast area and armpit once a day Monday through Friday for 5-6 weeks
After the study participants will return for checkups every 3-4 months during Years 1 and 2 every 6 months during years 3 and 4 and yearly after that During the check-ups participants will talk with and be examined by their physician Once a year patients will have yearly mammograms as needed chest-x rays and blood tests
This is an investigational study All of the drugs in this study are approved by the FDA for treatment of breast cancer A total of 930 patients will take part in this study All will be enrolled at M D Anderson
During the study participants will have blood tests done before each dose of chemotherapy For participants who have not had surgery a mammogram and sonogram will be done of the breast and armpit after completion of paclitaxel or docetaxelcapecitabine and after completion of fluorouracil cyclophosphamide and epirubicin FEC These studies will help doctors to keep track of the tumor size and help with the final decision whether to remove all or part of the breast and nearby lymph nodes after completion of chemotherapy
Participants in this study will be randomly assigned as in the toss of a coin to one of two treatment groups There is an equal chance of being in either group
Participants in Group I will receive paclitaxel once a week The drug will be given through a plastic tube in a vein over 1 hour for a total of 12 treatments Before each treatment patients will receive the drug Decadron dexamethasone through the vein and may receive Zofran ondansetron Benadryl diphenhydramine hydrochloride andor cimetidine to help decrease the risk of side effects from paclitaxel
Participants in Group II will receive docetaxel and capecitabine Docetaxel will be given once every 3 weeks Docetaxel will be given through a plastic tube in the vein over 1 hour Capecitabine will be started the same day docetaxel is given This medicine is given in a pill form The doctor will prescribe a dose of these pills based upon body weight and height Participants will take several pills two times a day for 14 days Participants will then not take any capecitabine pills for one week until the next dose of docetaxel is given This combination of docetaxel and capecitabine will be given four times over a period of 12 weeks Before each treatment patients will receive the drug Decadron dexamethasone by mouth
After treatment with either paclitaxel or docetaxelcapecitabine all participants will receive the drugs FEC through a plastic tube into a vein All of these drugs will be given once every three weeks for a total of 4 treatments 12 weeks total Decadron dexamethasone Zofran ondansetron and Benadryl diphenhydramine hydrochloride will be given before the chemotherapy to help decrease the risk of side effects
Participants who have a Her-2neu positive cancer will potentially be eligible to receive trastuzumab therapy for 1 year This medicine is given through a vein either once a week over 30 minutes or once every 3 weeks over 30 minutes Your doctor will discuss whether this medicine is appropriate for you
After all treatment is done participants whose tumors are sensitive to hormones estrogen will take a pill to help decrease the amount of hormone estrogen that can reach any tumor cells This pill will be taken once a day for 5 years
Participants who have not completed surgery for their cancer before receiving the chemotherapy described above will have surgery to remove all or part of the breast that has cancer If there are signs that the lymph nodes in the armpit axilla contain cancer these lymph nodes will also be removed
After chemotherapy and surgery or after completion of chemotherapy patients who had surgery done first participants may then receive radiation treatment to the breast area and armpit once a day Monday through Friday for 5-6 weeks
After the study participants will return for checkups every 3-4 months during Years 1 and 2 every 6 months during years 3 and 4 and yearly after that During the check-ups participants will talk with and be examined by their physician Once a year patients will have yearly mammograms as needed chest-x rays and blood tests
This is an investigational study All of the drugs in this study are approved by the FDA for treatment of breast cancer A total of 930 patients will take part in this study All will be enrolled at M D Anderson
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