ARRY-380 Twice Daily Dosage for HER2-positive Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HER2-positive Breast Cancer+1 MoreARRY-380 Once Daily - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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.