Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336791
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2006-06-12
Brief Title:
Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression Profile-Based Test to Select Patients for Preoperative TaxaneAnthracycline Chemotherapy for Stage I-III Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-02
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
1 To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response pCR to preoperative paclitaxelFAC 5-fluorouracil doxorubicin cyclophosphamide chemotherapy for stage I-III breast cancer
2 To evaluate if our genomic predictive test is specific to the paclitaxelFAC regimen or it also predicts increased sensitivity to FAC only chemotherapy
Secondary Objectives
1 To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
2 To establish a prospectively collected gene expression profile data bank of breast cancer for future studies
3 To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel FAC chemotherapies
1 To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response pCR to preoperative paclitaxelFAC 5-fluorouracil doxorubicin cyclophosphamide chemotherapy for stage I-III breast cancer
2 To evaluate if our genomic predictive test is specific to the paclitaxelFAC regimen or it also predicts increased sensitivity to FAC only chemotherapy
Secondary Objectives
1 To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
2 To establish a prospectively collected gene expression profile data bank of breast cancer for future studies
3 To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel FAC chemotherapies
Detailed Description:
The new test being studied measures the presence or absence of each of 12000-15000 human genes in the cancer using DNA chip technology All of the therapeutic treatment that you will receive is part of the standard of care Only the biopsy and Deoxyribonucleic acid DNA testing is investigational
Before and during chemotherapy you will need to have routine clinical and lab tests that are part of your standard of care These tests may include x-rays such as computed tomography CT scan of the liver or lung bone scan and mammograms or ultra sonograms of the breast to find out the extent of the cancer at the time of diagnosis Blood tests 1-2 tablespoon will be performed before each FAC 5-fluorouracil doxorubicin cyclophosphamide or FEC 5-fluorouracil epirubicin cyclophosphamide chemotherapy end at least once every 2 weeks during weekly paclitaxel therapy to make sure that it is safe to receive further treatment All of these tests are part of good clinical care and are not considered investigational
During treatment with FAC or FEC chemotherapy you will be seen by your physician every 3 weeks During the weekly paclitaxel treatment you will be seen by your physician every 4-6 weeks Additional visits may be necessary depending on your clinical course
During this study you will be asked to have a fine needle aspiration FNA of the cancer in your breast or lymph nodes The FNA procedure involves insertion of a small needle into the tumor to suction out aspirate cells from the cancer 3-4 times in one session A physician who is trained in this method will perform the procedure It could be done at the same time when the diagnosis of your cancer is made or it may be done at later time point The needle aspiration will have to be done before you start any chemotherapy for your cancer A DNA chip test called transcriptional profiling will be performed on the FNA specimens at M D Anderson in Houston TX USA The test will be done to try to predict if an individual is likely to have response to paclitaxelFAC chemotherapy or not This study is done to see how accurate this test is The chemotherapy response prediction test was developed by investigators at Millennium Pharmaceuticals Inc Cambridge MA USA and clinical scientists at M D Anderson This research may lead to the development of a commercial diagnostic test
Only patients who need chemotherapy to improve their chance of cure may participate in this study Whether you would benefit from chemotherapy or not will be decided by your physician During this study 18-24 weeks of chemotherapy will be given to you before surgery It is clear from several large clinical studies that chemotherapy works equally well regardless of whether you receive it before or after breast surgery By giving chemotherapy before surgery researchers can study why some cancers respond so well to treatment You may expect that 80-90 of the time the cancer will shrink and about 15-30 of the time the cancer will completely disappear from the breast or lymph nodes by the time you finish chemotherapy Many of the patients who experience the complete disappearance of cancer will be cured The purpose of this research is to find out who these individuals are and develop a test that could identify them at the time of the diagnosis About 5-10 of patients do not experience any shrinkage of the cancer and may experience growth of the tumor If the tumor grows during treatment you will be switched over to another chemotherapy you may receive radiation treatment or you may have surgery What is the best option for you will need to be decided by your treating physician
You will be randomly assigned as in the toss of a coin to one of two treatment groups
Participants in the first group will receive weekly treatments with the chemotherapy drug paclitaxel by vein After completion of 12 paclitaxel treatments you will receive 4 additional treatments with FAC or FEC combination chemotherapy The FAC or FEC treatments are given once every 3 weeks You and your physician will decide together if FAC or FEC is the more appropriate treatment for you Both of these treatments are believed to be equally effective but FAC is a longer treatment that requires 72-hour infusion whereas FEC can be given in one day The total length of treatment is 24 weeks after which you will have breast and lymph node surgery
Participants in the second group will receive 6 treatments 6 times 3 18 weeks with FAC or FEC before surgery Those patients who still have cancer in their breast or lymph nodes at the time of surgery may receive additional chemotherapy after the surgery with paclitaxel or a similar drug called docetaxel One large clinical study showed that addition of 4 courses of paclitaxel after 4 treatments with AC doxorubicin cyclophosphamide chemotherapy improved survival This is the reason why you may be recommended to receive paclitaxel or docetaxel treatment after surgery Whether you need additional postoperative chemotherapy or not will need to be discussed between you and your physician
After you completed all your treatments you will be contacted on the phone or by letter every 6 months for 10 years to find out how well you do and if the cancer has come back
This research will generate a large database of molecular abnormalities found in breast cancer Researchers will study the presence or absence of 12000-15000 human genes in the cancer of each patient who participates in this study This information along with the clinical features of the cancer will be stored in the database The age and race of patients as well as the long-term outcome of treatment will also be included in the database Other information about your health and family history of cancer may be added to the database in the future However your name address or date of birth will not be part of this research database The molecular data and the clinical information will be used to learn about the causes of breast cancer and to develop the best individual therapy for future patents
This is an investigational study The chemotherapy that you will receive is not experimental Paclitaxel FAC or FEC and their combination are commercially available drugs and are all approved by the FDA to treat newly diagnosed breast cancer A total of up to 273 patients will take part in this multicenter study Up to 150 may be enrolled at M D Anderson
Before and during chemotherapy you will need to have routine clinical and lab tests that are part of your standard of care These tests may include x-rays such as computed tomography CT scan of the liver or lung bone scan and mammograms or ultra sonograms of the breast to find out the extent of the cancer at the time of diagnosis Blood tests 1-2 tablespoon will be performed before each FAC 5-fluorouracil doxorubicin cyclophosphamide or FEC 5-fluorouracil epirubicin cyclophosphamide chemotherapy end at least once every 2 weeks during weekly paclitaxel therapy to make sure that it is safe to receive further treatment All of these tests are part of good clinical care and are not considered investigational
During treatment with FAC or FEC chemotherapy you will be seen by your physician every 3 weeks During the weekly paclitaxel treatment you will be seen by your physician every 4-6 weeks Additional visits may be necessary depending on your clinical course
During this study you will be asked to have a fine needle aspiration FNA of the cancer in your breast or lymph nodes The FNA procedure involves insertion of a small needle into the tumor to suction out aspirate cells from the cancer 3-4 times in one session A physician who is trained in this method will perform the procedure It could be done at the same time when the diagnosis of your cancer is made or it may be done at later time point The needle aspiration will have to be done before you start any chemotherapy for your cancer A DNA chip test called transcriptional profiling will be performed on the FNA specimens at M D Anderson in Houston TX USA The test will be done to try to predict if an individual is likely to have response to paclitaxelFAC chemotherapy or not This study is done to see how accurate this test is The chemotherapy response prediction test was developed by investigators at Millennium Pharmaceuticals Inc Cambridge MA USA and clinical scientists at M D Anderson This research may lead to the development of a commercial diagnostic test
Only patients who need chemotherapy to improve their chance of cure may participate in this study Whether you would benefit from chemotherapy or not will be decided by your physician During this study 18-24 weeks of chemotherapy will be given to you before surgery It is clear from several large clinical studies that chemotherapy works equally well regardless of whether you receive it before or after breast surgery By giving chemotherapy before surgery researchers can study why some cancers respond so well to treatment You may expect that 80-90 of the time the cancer will shrink and about 15-30 of the time the cancer will completely disappear from the breast or lymph nodes by the time you finish chemotherapy Many of the patients who experience the complete disappearance of cancer will be cured The purpose of this research is to find out who these individuals are and develop a test that could identify them at the time of the diagnosis About 5-10 of patients do not experience any shrinkage of the cancer and may experience growth of the tumor If the tumor grows during treatment you will be switched over to another chemotherapy you may receive radiation treatment or you may have surgery What is the best option for you will need to be decided by your treating physician
You will be randomly assigned as in the toss of a coin to one of two treatment groups
Participants in the first group will receive weekly treatments with the chemotherapy drug paclitaxel by vein After completion of 12 paclitaxel treatments you will receive 4 additional treatments with FAC or FEC combination chemotherapy The FAC or FEC treatments are given once every 3 weeks You and your physician will decide together if FAC or FEC is the more appropriate treatment for you Both of these treatments are believed to be equally effective but FAC is a longer treatment that requires 72-hour infusion whereas FEC can be given in one day The total length of treatment is 24 weeks after which you will have breast and lymph node surgery
Participants in the second group will receive 6 treatments 6 times 3 18 weeks with FAC or FEC before surgery Those patients who still have cancer in their breast or lymph nodes at the time of surgery may receive additional chemotherapy after the surgery with paclitaxel or a similar drug called docetaxel One large clinical study showed that addition of 4 courses of paclitaxel after 4 treatments with AC doxorubicin cyclophosphamide chemotherapy improved survival This is the reason why you may be recommended to receive paclitaxel or docetaxel treatment after surgery Whether you need additional postoperative chemotherapy or not will need to be discussed between you and your physician
After you completed all your treatments you will be contacted on the phone or by letter every 6 months for 10 years to find out how well you do and if the cancer has come back
This research will generate a large database of molecular abnormalities found in breast cancer Researchers will study the presence or absence of 12000-15000 human genes in the cancer of each patient who participates in this study This information along with the clinical features of the cancer will be stored in the database The age and race of patients as well as the long-term outcome of treatment will also be included in the database Other information about your health and family history of cancer may be added to the database in the future However your name address or date of birth will not be part of this research database The molecular data and the clinical information will be used to learn about the causes of breast cancer and to develop the best individual therapy for future patents
This is an investigational study The chemotherapy that you will receive is not experimental Paclitaxel FAC or FEC and their combination are commercially available drugs and are all approved by the FDA to treat newly diagnosed breast cancer A total of up to 273 patients will take part in this multicenter study Up to 150 may 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