Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01494662
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2011-12-14
Brief Title:
HKI-272 for HER2-Positive Breast Cancer and Brain Metastases
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of HKI-272 Neratinib Neratinib and Capecitabine and Ado-Trastuzumab Emtansine for Patients With Human Epidermal Growth Factor Receptor 2 HER2-Positive Breast Cancer and Brain Metastases
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting or blocking members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 HER2
In this research study the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain The investigators are also looking at how previous treatments have affected your thinking or cognition and how much neratinib reaches the central nervous system
In this research study the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain The investigators are also looking at how previous treatments have affected your thinking or cognition and how much neratinib reaches the central nervous system
Detailed Description:
Subjects will receive neratinib and a drug-dosing calendar for each treatment cycle This drug is given orally on a daily basis continuously Each treatment cycle will last for 4 weeks during which time the subject will be taking neratinib every day
Physical Exams and vital signs At the start of each cycle you will have a physical exam You will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking You will also have a neurological examination to assess for neurological symptoms
Scans or Imaging tests We will assess your tumor by brain MRI every 2 cycles 6 to 8 weeks and then every 3 cycles 9 to 12 weeks CT or MRI scans of your chest abdomen and pelvis will be performed every other cycle at the same time points as the brain MRI Your research doctor may ask you to have a bone scan at the same time points if this is clinically indicated
Photographs Photographs may be taken of your tumor to assess the response of your tumor to the treatment Care will be taken to ensure these do not reveal your identity
MUGA or Echo You will have a MUGA or ECHO done every 12 weeks so every 3 or 4 treatment cycles depending on which cohort you are on
Blood tests You will have blood tests done at the beginning of each treatment cycle to check your blood cell counts and how well your organs are functioning In addition to regular blood tests we will be collecting 2-3 tablespoons of blood for research prior to your study treatment start
Neurocognitive Function If you have previously received treatment for cancer that has spread to your brain prior to enrollment on this study you will be asked to take a battery of tests that assess your cognition thinking at the start of the study after 2 cycles of treatment and possibly at the end of the study With these tests we are trying to better understand how your previous treatments and ongoing treatments affect your memory attention learning and other related skills These tests will be administered to you by a trained research assistant and may take 30-45 minutes to complete
For preoperative patients only If you are a patient who is planning to have an operation to remove the cancer in your brain you will have your surgery between 7-21 days after starting neratinib These tests will allow us to measure of how much drug neratinib reaches the central nervous system and will help us understand how well neratinib does this
At surgery a part of your tumor cerebrospinal fluid will be collected to test for levels of neratinib For the cerebrospinal fluid collection this may require a lumbar puncture just before your surgery begins spinal tap if your neurosurgeon feels heshe cannot collect this fluid easily during your surgery A lumbar puncture is a test often used to detect tumor cells in your cerebrospinal fluid In this case we will collect fluid for testing of cancer cells and will also examine the fluid for neratinib concentrations This will provide information on how much drug neratinib reaches the central nervous system There will be a separate consent form for this procedure given to you by your neurosurgeon when applicable This procedure will be done while you are already under general anesthesia for your surgery If you have a contraindication to having this procedure or if you wish to refuse to undergo this procedure you may do so
You will also have a blood test on day of surgery to test for levels of neratinib
You will then resume neratinib once you have recovered from your surgery
After the final dose of the study drug
You will have a follow-up visit one month after coming off study treatment During that visit you will have a physical examination functional assessment assessment of any toxicities and current medications and a neurological examination If you continue to have ongoing toxicity related to your study treatment we will continue to follow you until this toxicity resolves In addition we will collect about 5-6 tablespoons of blood for research and to measure if a marker for your particular breast cancer exists
We would like to keep track of your medical condition for up to two years after you stop the study treatment If you are not seen in follow-up at your participating center where you enrolled on the study we would like to follow you by calling you on the telephone or by sending you a letter once a year to see how you are doing We may also contact your doctor once every 6 months to see how you are doing Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study If you do not wish to be contacted after you stop the study treatment you must notify the research study staff of your withdrawal of consent for follow-up
Physical Exams and vital signs At the start of each cycle you will have a physical exam You will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking You will also have a neurological examination to assess for neurological symptoms
Scans or Imaging tests We will assess your tumor by brain MRI every 2 cycles 6 to 8 weeks and then every 3 cycles 9 to 12 weeks CT or MRI scans of your chest abdomen and pelvis will be performed every other cycle at the same time points as the brain MRI Your research doctor may ask you to have a bone scan at the same time points if this is clinically indicated
Photographs Photographs may be taken of your tumor to assess the response of your tumor to the treatment Care will be taken to ensure these do not reveal your identity
MUGA or Echo You will have a MUGA or ECHO done every 12 weeks so every 3 or 4 treatment cycles depending on which cohort you are on
Blood tests You will have blood tests done at the beginning of each treatment cycle to check your blood cell counts and how well your organs are functioning In addition to regular blood tests we will be collecting 2-3 tablespoons of blood for research prior to your study treatment start
Neurocognitive Function If you have previously received treatment for cancer that has spread to your brain prior to enrollment on this study you will be asked to take a battery of tests that assess your cognition thinking at the start of the study after 2 cycles of treatment and possibly at the end of the study With these tests we are trying to better understand how your previous treatments and ongoing treatments affect your memory attention learning and other related skills These tests will be administered to you by a trained research assistant and may take 30-45 minutes to complete
For preoperative patients only If you are a patient who is planning to have an operation to remove the cancer in your brain you will have your surgery between 7-21 days after starting neratinib These tests will allow us to measure of how much drug neratinib reaches the central nervous system and will help us understand how well neratinib does this
At surgery a part of your tumor cerebrospinal fluid will be collected to test for levels of neratinib For the cerebrospinal fluid collection this may require a lumbar puncture just before your surgery begins spinal tap if your neurosurgeon feels heshe cannot collect this fluid easily during your surgery A lumbar puncture is a test often used to detect tumor cells in your cerebrospinal fluid In this case we will collect fluid for testing of cancer cells and will also examine the fluid for neratinib concentrations This will provide information on how much drug neratinib reaches the central nervous system There will be a separate consent form for this procedure given to you by your neurosurgeon when applicable This procedure will be done while you are already under general anesthesia for your surgery If you have a contraindication to having this procedure or if you wish to refuse to undergo this procedure you may do so
You will also have a blood test on day of surgery to test for levels of neratinib
You will then resume neratinib once you have recovered from your surgery
After the final dose of the study drug
You will have a follow-up visit one month after coming off study treatment During that visit you will have a physical examination functional assessment assessment of any toxicities and current medications and a neurological examination If you continue to have ongoing toxicity related to your study treatment we will continue to follow you until this toxicity resolves In addition we will collect about 5-6 tablespoons of blood for research and to measure if a marker for your particular breast cancer exists
We would like to keep track of your medical condition for up to two years after you stop the study treatment If you are not seen in follow-up at your participating center where you enrolled on the study we would like to follow you by calling you on the telephone or by sending you a letter once a year to see how you are doing We may also contact your doctor once every 6 months to see how you are doing Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study If you do not wish to be contacted after you stop the study treatment you must notify the research study staff of your withdrawal of consent for follow-up
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 |
|---|---|---|---|
| TBCRC 022 | OTHER | TBCRC | None |