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Ribociclib with Trastuzumab or T-DM1 in HER2+ Breast Cancer
NCT02657343Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2016
- Primary completion
- Aug 2020
- Countries
- 1
- Sponsor
- Dana-Farber Cancer Institute
- Modality
- Small Molecules
- Drugs
- ribociclib
- Conditions
- breast cancer
01
Overview
Phase 2, open-label trial of ribociclib in breast cancer (3 arms), sponsored by Dana-Farber Cancer Institute. Primary endpoints: Recommended Phase 2 Dose at Cycle 1 and Clinical Benefit Rate at 12 weeks. Started Mar 2016; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Ribociclib + T-DM1
Ribociclib (dose escalation) + T-DM1
Ribociclib + Trastuzumab
Ribociclib (400 mg) + Trastuzumab
Ribociclib + Trastuzumab + Fulvestrant
Ribociclib + Trastuzumab + Fulvestrant
03
Who it enrols
Patients with histologically confirmed invasive HER2-positive breast cancer (locally advanced or metastatic) who have received prior HER2-directed therapies. Patients must have adequate organ function and no prior CDK 4/6 inhibitor treatment.
04
Endpoints
Primary
Recommended Phase 2 Dose
Clinical Benefit Rate
Secondary
Incidence of Grade 3 Treatment-Related Toxicity
Pharmacokinetic Profile
Objective Response Rate
Progression-Free Survival
Overall Survival
Frequency of Biomarkers
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