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HKI-272 for Breast Cancer
Study Summary
This trial will test how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a drug that may stop breast cancer cells from growing by inhibiting proteins that include HER2. The trial will look at how well neratinib works to decrease the size of or stabilize breast cancer in the brain, and also how it affects thinking and how much neratinib reaches the central nervous system.
- Breast Cancer
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are receiving other treatments for cancer at the same time as this study, except for certain bone-strengthening medications.If you have a long-term condition that causes moderate or severe diarrhea, you cannot participate.You have cancer that has spread to the covering of the brain and spinal cord as the only place in the central nervous system.For cohort 1, you need to have a brain lesion that can be measured and is at least 10 millimeters long according to local radiology review. It's okay if you don't have measurable non-brain disease for this study.You have had another type of cancer that is currently active.You can have had treatment with trastuzumab and lapatinib before.You must have confirmed invasive breast cancer that has spread to other parts of the body, either through biopsy or other diagnostic tests.The tumor or tissue sample must show high levels of the HER2 protein and/or extra copies of the HER2 gene. If the results are negative or uncertain, you cannot join the study.If you are in cohort 2 and have brain disease, it should be possible to remove it with surgery (usually less than 3 brain metastases).In the third group, patients must have measurable brain disease. Subgroup 3a will include participants who haven't had lapatinib treatment before, while subgroup 3b will include those who have had lapatinib treatment in the past.For group 4, people must have measurable brain disease. Subgroup 4a includes people with new brain tumors. Subgroup 4b includes people with growing brain tumors. Subgroup 4c includes people with growing brain tumors and previous treatment with T-DM1.You are currently taking certain medications for epilepsy that can affect the study drug.There is no restriction on the number of previous treatments you have received, including chemotherapy, trastuzumab, and hormone therapies.You have had chemotherapy or radiotherapy within the past 2 weeks, or you have not fully recovered from side effects of previous treatments taken more than 4 weeks ago (except for hair loss). You do not need to stop taking trastuzumab before joining the study.You have had allergic reactions to drugs similar to neratinib.You have had more than two seizures in the last 4 weeks before joining the study.Patients in cohort 1 must have new or growing brain or spinal cord lesions, as determined by their doctor.
- Group 1: Cohort 3a/3b
- Group 2: Cohort 4a/4b/4c
- Group 3: Cohort 1
- Group 4: Cohort 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what degree are members of Cohorts 3a/3b protected from potential harm?
"A score of 2 was assigned to Cohort 3a/3b as the Phase 2 trial has evidence suggesting safety but not efficacy."
How many sites have been enlisted to administer this clinical trial?
"This trial is being conducted in 15 different places, including Harrisburg, San Francisco and Boston. To reduce the strain of travel on participants, it would be prudent to choose a clinic near your location should you decide to join this study."
Has Cohort 3a/3b been included in any past experiments?
"Presently, there are 387 trials in progress for Cohort 3a/3b with 135 of them currently at the Phase 3 stage. Although many studies related to this cohort take place in Woolloongabba, Queensland, 18867 other locations across the world run these types of experiments as well."
Is participation in this clinical experiment open to the public?
"According to the information shared on clinicaltrials.gov, this medical trial has concluded its patient recruitment phase and is no longer actively looking for participants. This study was first posted in February of 2012 with a final update made in May 2022; however, there are currently 3333 other trials that are still seeking individuals to join their research efforts."
What diseases are treated by Cohort 3a/3b?
"Cohort 3a/3b is largely used to combat malignant neoplasms, but has also proven effective in treating pancreatic endocrine carcinoma, colorectal cancer, and refractory ovarian cancers."
How many individuals have enrolled in the clinical trial to date?
"At this time, no further enrolment is being taken for this trial. The original posting was made on February 1st 2012 with the last update taking place in May 25th 2022. There are still 2946 clinical trials actively recruiting patients affected by breast cancer and 387 studies presently seeking Cohort 3a/3b participants."
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