Study Summary
This trial will test the safety of different doses of ARRY-380 in combination with trastuzumab to see if the combination is safe for people to take.
Eligible Conditions
- HER2-positive Breast Cancer
- Brain Metastases From HER2-Positive Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 2 years
2 Years
CNS objective response rate according to volumetric criteria
Clinical benefit (CR, PR, or SD>/=24 weeks)
Overall survival
Progression-free survival
Proportion of participants with stable or responsive disease in both CNS and non-CNS at 16 and 24 weeks.
2 years
CNS Response according to modified RECIST 1.1
Determine Maximum-tolerated dose of ARRY-380 with Trastuzumab
Non-CNS objective response rate according to RECIST 1.1
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
ARRY-380 Twice Daily Dosage
1 of 2
ARRY-380 Once Daily
1 of 2
Active Control
41 Total Participants · 2 Treatment Groups
Primary Treatment: ARRY-380 Twice Daily Dosage · No Placebo Group · Phase 1
ARRY-380 Twice Daily DosageActiveComparator Group · 2 Interventions: ARRY-380 Twice Daily Dosage, Trastuzumab · Intervention Types: Drug, Drug
ARRY-380 Once DailyActiveComparator Group · 2 Interventions: ARRY-380 Once Daily, Trastuzumab · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,757 Total Patients Enrolled
6 Trials studying HER2-positive Breast Cancer
1,426 Patients Enrolled for HER2-positive Breast Cancer
Breast Cancer Research FoundationOTHER
60 Previous Clinical Trials
135,386 Total Patients Enrolled
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,574 Total Patients Enrolled
Nancy Lin, MDPrincipal InvestigatorDana-Farber Cancer Institute
8 Previous Clinical Trials
470 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have HER2+ (3+ by immunohistochemistry and/or FISH ratio >/= 2.0) invasive breast cancer.
You have a new or progressive CNS lesion.
You have had prior WBRT and/or SRS and then whose lesions have progressed thereafter.
References
- Metzger Filho, O., J.P. Leone, T. Li, Z. Tan-Wasielewski, L. Trippa, W.T. Barry, J. Younger, et al.. 2020. “Phase I Dose-escalation Trial of Tucatinib in Combination with Trastuzumab in Patients with Her2-positive Breast Cancer Brain Metastases”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2020.05.014.
- Nancy Lin, MD 2013. "ARRY-380 + Trastuzuamab for Breast w/ Brain Mets". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01921335.
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Conditions
Cancer Related
Treatments