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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
Prior trastuzumab and lapatinib therapy are allowed.
There is no limit to the number of previous lines of therapy (including chemotherapy, trastuzumab, and endocrine therapies).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You can have had treatment with trastuzumab and lapatinib before.
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There is no restriction on the number of previous treatments you have received, including chemotherapy, trastuzumab, and hormone therapies.
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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.
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You must have confirmed invasive breast cancer that has spread to other parts of the body, either through biopsy or other diagnostic tests.
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Patients in cohort 1 must have new or growing brain or spinal cord lesions, as determined by their doctor.
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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).
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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.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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
Secondary outcome measures
Circulating Neoplastic Cells
CNS response by Macdonald criteria
Clinical outcomes
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,066 Previous Clinical Trials
338,844 Total Patients Enrolled
139 Trials studying Breast Cancer
21,431 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,217 Total Patients Enrolled
12 Trials studying Breast Cancer
1,435 Patients Enrolled for Breast Cancer
Puma Biotechnology, Inc.Industry Sponsor
56 Previous Clinical Trials
9,652 Total Patients Enrolled
13 Trials studying Breast Cancer
4,257 Patients Enrolled for Breast Cancer

Media Library

HKI-272 (Small Molecule Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01494662 — Phase 2
Breast Cancer Research Study Groups: Cohort 3a/3b, Cohort 4a/4b/4c, Cohort 1, Cohort 2
Breast Cancer Clinical Trial 2023: HKI-272 Highlights & Side Effects. Trial Name: NCT01494662 — Phase 2
HKI-272 (Small Molecule Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01494662 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~11 spots leftby Feb 2025