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Small Molecule Kinase Inhibitor
HKI-272 for Breast Cancer
Phase 2
Waitlist Available
Led By Rachel Freedman, M.D., M.P.H.
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from date of trial registration until the date of death from any cause, up to 5 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with invasive breast cancer that has spread to the brain (HER2-positive). Participants must have measurable brain lesions, not be on certain treatments like neratinib before, and can't be taking concurrent cancer therapies. Pregnant or breastfeeding individuals, those with specific medical conditions or allergies to similar drugs, and patients who cannot tolerate oral medications are excluded.Check my eligibility
What is being tested?
The study tests how well neratinib works on breast cancer in the brain. It's an oral drug blocking proteins involved in cancer cell growth. The trial examines its effect on tumor size/stability and cognitive function impact while monitoring how much reaches the central nervous system.See study design
What are the potential side effects?
Potential side effects of neratinib may include diarrhea (which excludes participants with a predisposition), possible allergic reactions to similar compounds, and general intolerance to oral medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from date of trial registration until the date of death from any cause, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from date of trial registration until the date of death from any cause, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate Per Composite Response Criteria
Objective Response Rate Per RANO-BM Criteria
Secondary outcome measures
CNS Response by Macdonald Criteria (Bidirectional Criteria)
Objective Response Based on CNS Composite Criteria for Extension Subgroup of Cohort 1
Objective Response Rate in CNS by Volumetric Criteria
+3 moreTrial Design
4Treatment groups
Active Control
Group I: Cohort 3a/3bActive Control1 Intervention
Cohort 3a will be made up of participants with No Prior Lapatinib Treatment. They will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
Cohort 3b will be made of of participants with Prior Lapatinib Treatment. Cohort 3b participants will receive Neratinib 240mg Orally daily and 750mg/m2 Capecitabine twice per day for 14 days followed by 7 days rest.
Group II: Cohort 4a/4b/4cActive Control2 Interventions
Cohort 4a will be made up of participants with previously untreated brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
Cohort 4b will be made up of participants with progressive brain metastases. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
Cohort 4c will be made up of participants with progressive brain metastases and prior T-DM1. They will receive Neratinib 160mg Orally daily and T-DM1 3.6mg/kg IV every 3 weeks.
Group III: Cohort 1Active Control1 Intervention
Patients With Progressive Brain Metastases
Intervention: HKI-272 (Neratinib)340 mg orally, once daily.
Group IV: Cohort 2Active Control1 Intervention
Patients Who Are Candidates For Craniotomy.
Intervention: HKI-272 (Neratinib) 240 mg orally, once daily.
Surgical resection (biopsy).
Neratinib concentrations from craniotomy specimen, CSF, plasma Neratinib.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,085 Previous Clinical Trials
341,640 Total Patients Enrolled
142 Trials studying Breast Cancer
22,552 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
23 Previous Clinical Trials
2,278 Total Patients Enrolled
13 Trials studying Breast Cancer
1,496 Patients Enrolled for Breast Cancer
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
9,809 Total Patients Enrolled
13 Trials studying Breast Cancer
4,248 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3a/3b
- Group 2: Cohort 4a/4b/4c
- Group 3: Cohort 1
- Group 4: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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