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
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 2 years
2 years
Circulating Neoplastic Cells
CNS response by Macdonald criteria
Clinical outcomes
First site of disease progression
Objective Response Rate
Overall Survival
Progression-Free Survival
Safety and Tolerability
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Cohort 3a/3b
1 of 4
Cohort 2
1 of 4
Cohort 4a/4b/4c
1 of 4
Cohort 1
1 of 4
Active Control
140 Total Participants · 4 Treatment Groups
Primary Treatment: Cohort 3a/3b · No Placebo Group · Phase 2
Cohort 3a/3b
Drug
ActiveComparator Group · 1 Intervention: Capecitabine · Intervention Types: DrugCohort 2
Procedure
ActiveComparator Group · 1 Intervention: Surgical Resection · Intervention Types: ProcedureCohort 4a/4b/4cActiveComparator Group · 2 Interventions: HKI-272, Ado-Trastuzumab Emtansine · Intervention Types: Drug, Drug
Cohort 1
Drug
ActiveComparator Group · 1 Intervention: HKI-272 · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Puma Biotechnology, Inc.Industry Sponsor
52 Previous Clinical Trials
9,529 Total Patients Enrolled
13 Trials studying Breast Cancer
4,257 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
21 Previous Clinical Trials
2,148 Total Patients Enrolled
11 Trials studying Breast Cancer
1,353 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,658 Total Patients Enrolled
134 Trials studying Breast Cancer
21,528 Patients Enrolled for Breast Cancer
Rachel Freedman, M.D., M.P.H.Principal Investigator - Dana-Farber Cancer Institute
Brigham & Women's Faulkner Hospital, Brigham & Women's Hospital, Dana-Farber Cancer Institute
Georgetown University School Of Medicine (Medical School)
Brigham & Women'S Hospital (Residency)
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients must have histologically or cytologically confirmed invasive breast cancer, with metastatic disease
The tumor must be HER2-positive.
Patients with a negative or equivocal overall result (FISH ratio of < 2.0 or ≤ 6.0 HER2 gene copies per nucleus) and IHC staining scores of 0, 1+, 2+ are not eligible for enrollment.
You have not had an increase in corticosteroid dose in the week prior to your baseline brain MRI.
No washout is required for hormonal therapy but concurrent hormonal therapy is not allowed for patients on study.
References
- Freedman, Rachel A., Rebecca S. Gelman, Carey K. Anders, Michelle E. Melisko, Heather A. Parsons, Anne M. Cropp, Kelly Silvestri, et al.. 2019. “TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients with Human Epidermal Growth Factor Receptor 2–positive Breast Cancer and Brain Metastases”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.18.01511.
- Freedman, Rachel A., Rebecca S. Gelman, Nathalie Y.R. Agar, Sandro Santagata, Elizabeth C. Randall, Begoña Gimenez-Cassina Lopez, Roisin M. Connolly, et al.. 2020. “Pre- and Postoperative Neratinib for Her2-positive Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium 022”. Clinical Breast Cancer. Elsevier BV. doi:10.1016/j.clbc.2019.07.011.
- Freedman, Rachel A., Rebecca S. Gelman, Jeffrey S. Wefel, Michelle E. Melisko, Kenneth R. Hess, Roisin M. Connolly, Catherine H. Van Poznak, et al.. 2016. “Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients with Human Epidermal Growth Factor Receptor 2–positive Breast Cancer and Brain Metastases”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.63.0343.
- Rachel Freedman, MD, MPH 2012. "HKI-272 for HER2-Positive Breast Cancer and Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01494662.
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Conditions
Cancer Related
Treatments