Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499603
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2007-07-09
Brief Title:
Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women With Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Open Label Randomized Clinical Trial of Standard Neoadjuvant Chemotherapy Paclitaxel Followed by FEC Versus the Combination of Paclitaxel and RAD001 Followed by FEC in Women With Triple Receptor-Negative Breast Cancer CRAD001C24101
Status:
UNKNOWN
Status Verified Date:
2016-09
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 goal of this clinical research is to learn if RAD001 given in combination with chemotherapy will turn off the signaling pathway a chain of information that tells cancer cells to grow quickly and make the chemotherapies given on this study more effective
Primary Objective
To determine if the addition of an mTOR inhibitor to standard neoadjuvant chemotherapy in patients with triple receptor-negative breast cancer causes molecular changes inhibitionactivation of the PI3KPTENAKT pathway
Secondary Objectives
To evaluate pathologic complete response pCR rates for each treatment group
To evaluate the relationship between pCR and the molecular changes inhibitionactivation of the PI13KPTENAKT pathway in each treatment group
To evaluate overall response rates ORR for each treatment group
To assess the toxicity of both regimens and to evaluate the relationship of toxicities with PI3KPTENAKT pathway status
Primary Objective
To determine if the addition of an mTOR inhibitor to standard neoadjuvant chemotherapy in patients with triple receptor-negative breast cancer causes molecular changes inhibitionactivation of the PI3KPTENAKT pathway
Secondary Objectives
To evaluate pathologic complete response pCR rates for each treatment group
To evaluate the relationship between pCR and the molecular changes inhibitionactivation of the PI13KPTENAKT pathway in each treatment group
To evaluate overall response rates ORR for each treatment group
To assess the toxicity of both regimens and to evaluate the relationship of toxicities with PI3KPTENAKT pathway status
Detailed Description:
RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer It may also stop the growth of new blood vessels that help tumor growth resulting in cell death
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete physical exam Blood about 6 tablespoons will be drawn for routine tests and to test for the amount of fat in the blood You will have a chest x-ray bone scan and a 2-D echocardiogram a test to evaluate the pumping function of the heart You will have a computed tomography CT scan of the chest and abdomen stomach area Women who are able to have children must have a negative blood about 1 tablespoon pregnancy test
You will have a mammogram and an ultrasound of the breast and armpit to record tumor size As part of this study you will have a fine needle biopsy of the breast tumor to test for the signaling pathway You will receive a separate consent form for the mammogram ultrasound and biopsy and these procedures will be discussed with you in more detail The fine needle biopsy is a procedure that would not be performed if you were not on this study
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of two treatment groups You will have an equal chance of being assigned to either group
If you are assigned to Group 1 you will receive paclitaxel once a week through a needle in your vein over 1 hour You will have a total of 12 treatments Before each treatment you may also receive drugs to help prevent or reduce your risk of side effects from paclitaxel
If you are assigned to Group 2 you will receive paclitaxel and RAD001 You will receive paclitaxel once a week through a needle in your vein over 1 hour You will have a total of 12 treatments Before each treatment you may also receive drugs to help prevent or reduce your risk of side effects from paclitaxel You will take RAD001 by mouth on each day you receive paclitaxel You should take RAD001 on an empty stomach or after a light meal Pills will not be taken out of their package until the staff is ready for you to take them since they can be damaged by light or humidity
Participants in both groups will have blood about 2 tablespoons drawn for routine tests before each weekly dose of chemotherapy
You will have a second fine needle biopsy 2 days after starting treatment This will be done to check to see if the signaling pathway has been affected
After your 12 weeks of treatment with paclitaxel or paclitaxel and RAD001 you will have an ultrasound and if tumor is visible a fine needle biopsy to check to see if the signaling pathway has been affected
After the 12 week treatment with either paclitaxel or paclitaxel and RAD001 you will begin treatment with 5-fluorouracil epirubicin and cyclophosphamide This drug combination is called FEC You will receive FEC through needle in your vein over 1 hour once every 3 weeks You will have 4 treatments 12 weeks total Before each treatment you may also receive drugs to help prevent or reduce your risk of side effects from FEC
Once you have finished treatment with FEC you will have a mammogram and ultrasound to check the status of the disease This mammogram and ultrasound will also be used by the doctor to decide whether to remove all or part of the breast andor nearby lymph nodes during surgery
You will then have surgery to remove all or part of the breast that has the tumor If there are signs that the lymph nodes in the armpit contain cancer these lymph nodes will also be removed You will receive a separate consent form for these procedures and your doctor will discuss them in more detail If available a portion of left over tumor tissue will be collected to check to see if the signaling pathway has been affected
You will be considered off study once you have had surgery You will be taken off study early if the disease gets worse or intolerable side effects occur
This is an investigational study Paclitaxel 5-fluorouracil cyclophosphamide and epirubicin are all FDA approved and commercially available RAD001 is not FDA approved or commercially available It has been authorized for use in research only Up to 50 patients will take part in this study All will be enrolled at M D Anderson
Before you can start treatment on this study you will have screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete physical exam Blood about 6 tablespoons will be drawn for routine tests and to test for the amount of fat in the blood You will have a chest x-ray bone scan and a 2-D echocardiogram a test to evaluate the pumping function of the heart You will have a computed tomography CT scan of the chest and abdomen stomach area Women who are able to have children must have a negative blood about 1 tablespoon pregnancy test
You will have a mammogram and an ultrasound of the breast and armpit to record tumor size As part of this study you will have a fine needle biopsy of the breast tumor to test for the signaling pathway You will receive a separate consent form for the mammogram ultrasound and biopsy and these procedures will be discussed with you in more detail The fine needle biopsy is a procedure that would not be performed if you were not on this study
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of two treatment groups You will have an equal chance of being assigned to either group
If you are assigned to Group 1 you will receive paclitaxel once a week through a needle in your vein over 1 hour You will have a total of 12 treatments Before each treatment you may also receive drugs to help prevent or reduce your risk of side effects from paclitaxel
If you are assigned to Group 2 you will receive paclitaxel and RAD001 You will receive paclitaxel once a week through a needle in your vein over 1 hour You will have a total of 12 treatments Before each treatment you may also receive drugs to help prevent or reduce your risk of side effects from paclitaxel You will take RAD001 by mouth on each day you receive paclitaxel You should take RAD001 on an empty stomach or after a light meal Pills will not be taken out of their package until the staff is ready for you to take them since they can be damaged by light or humidity
Participants in both groups will have blood about 2 tablespoons drawn for routine tests before each weekly dose of chemotherapy
You will have a second fine needle biopsy 2 days after starting treatment This will be done to check to see if the signaling pathway has been affected
After your 12 weeks of treatment with paclitaxel or paclitaxel and RAD001 you will have an ultrasound and if tumor is visible a fine needle biopsy to check to see if the signaling pathway has been affected
After the 12 week treatment with either paclitaxel or paclitaxel and RAD001 you will begin treatment with 5-fluorouracil epirubicin and cyclophosphamide This drug combination is called FEC You will receive FEC through needle in your vein over 1 hour once every 3 weeks You will have 4 treatments 12 weeks total Before each treatment you may also receive drugs to help prevent or reduce your risk of side effects from FEC
Once you have finished treatment with FEC you will have a mammogram and ultrasound to check the status of the disease This mammogram and ultrasound will also be used by the doctor to decide whether to remove all or part of the breast andor nearby lymph nodes during surgery
You will then have surgery to remove all or part of the breast that has the tumor If there are signs that the lymph nodes in the armpit contain cancer these lymph nodes will also be removed You will receive a separate consent form for these procedures and your doctor will discuss them in more detail If available a portion of left over tumor tissue will be collected to check to see if the signaling pathway has been affected
You will be considered off study once you have had surgery You will be taken off study early if the disease gets worse or intolerable side effects occur
This is an investigational study Paclitaxel 5-fluorouracil cyclophosphamide and epirubicin are all FDA approved and commercially available RAD001 is not FDA approved or commercially available It has been authorized for use in research only Up to 50 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23CA121994 | NIH | NCI | httpsreporternihgovquickSearch1K23CA121994 |
| NCI-2012-01514 | REGISTRY | None | None |
| 1K23CA121994-1 | OTHER_GRANT | None | None |