I checked the primary completion date: November 2016
There may be interim reports.
I want to thank Kiri for enrolling in the trial. She is the pioneer that will help to determine effective doses and side effects.
This trial sounds very promising for CNS mets. She is in our hearts and prayers for an outstanding result.
Primary Outcome Measures:
- Determine Maximum-tolerated dose of ARRY-380 with Trastuzumab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To determine the maximum-tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ARRY-380 in combination with trastuzumab in participants with HER2+ breast cancer and central nervous system (CNS metastasis)
Secondary Outcome Measures:
- CNS objective response rate according to volumetric criteria [ Time Frame: 2 Years ] [ Designated as safety issue: No ]CNS objective response rate according to volumetric criteria
- Non-CNS objective response rate according to RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]Non-CNS objective response rate according to RECIST 1.1
- Proportion of participants with stable or responsive disease in both CNS and non-CNS at 16 and 24 weeks. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Proportion of participants with stable or responsive disease in both CNS and non-CNS at 16 and 24 weeks.
- Progression-free survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Progression-free survival
- Clinical benefit (CR, PR, or SD>/=24 weeks) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Clinical benefit (CR, PR, or SD>/=24 weeks)
- Overall survival [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Overall survival
- CNS Response according to modified RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 50 Study Start Date: August 2013 Estimated Study Completion Date: November 2019 Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Hybrid Mode
