Study Summary
This trial is testing ibrutinib given with trastuzumab to see if it is safe and what the highest dose that can be given is. It is for people with HER2-positive metastatic breast cancer that has gotten worse after other treatments.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: 24 months
24 months
Cytokine Gene Expression Analysis
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of ibrutinib plus trastuzumab.
Median Overall Survival
Median Progression-free Survival
Objective Response Rate
Pharmacokinetic Analysis for Ibrutinib (Phase I only)- Area under Curve
Pharmacokinetic Analysis for Ibrutinib (Phase I only)- Cmax
Phase I: Maximum Tolerated Dose
Phase II: Clinical Benefit Rate
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Trastuzumab plus Ibrutinib 560 mg
1 of 4
Phase II- Trastuzumab plus Maximum Tolerated Dose
1 of 4
Trastuzumab plus Ibrutinib 420 mg
1 of 4
Trastuzumab plus Ibrutinib 840 mg
1 of 4
Experimental Treatment
26 Total Participants · 4 Treatment Groups
Primary Treatment: Trastuzumab · No Placebo Group · Phase 1 & 2
Trastuzumab plus Ibrutinib 560 mgExperimental Group · 2 Interventions: Trastuzumab, Ibrutinib 560 mg · Intervention Types: Drug, Drug
Phase II- Trastuzumab plus Maximum Tolerated Dose
Drug
Experimental Group · 1 Intervention: Trastuzumab · Intervention Types: DrugTrastuzumab plus Ibrutinib 420 mgExperimental Group · 2 Interventions: Trastuzumab, Ibrutinib 420 mg · Intervention Types: Drug, Drug
Trastuzumab plus Ibrutinib 840 mgExperimental Group · 2 Interventions: Ibrutinib 840 mg, Trastuzumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Who is running the clinical trial?
US Oncology ResearchLead Sponsor
35 Previous Clinical Trials
8,271 Total Patients Enrolled
5 Trials studying Breast Cancer
3,587 Patients Enrolled for Breast Cancer
AbbVieIndustry Sponsor
835 Previous Clinical Trials
471,294 Total Patients Enrolled
7 Trials studying Breast Cancer
454 Patients Enrolled for Breast Cancer
Pharmacyclics LLC.Industry Sponsor
112 Previous Clinical Trials
14,490 Total Patients Enrolled
1 Trials studying Breast Cancer
124 Patients Enrolled for Breast Cancer
Joyce O'Shaughnessy, MDPrincipal InvestigatorUS Oncology Research/McKesson Specialty Health
7 Previous Clinical Trials
109 Total Patients Enrolled
2 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:AST and/or ALT ≤5.0 x ULN or ≤3 x ULN in the absence of liver metastases.
HER2/CEP17 ratio ≥2 or an average of ≥6 HER2 gene copies per cell by in situ hybridization (ISH) according to the 2013 American Society of Clinical Oncology (ASCO)/CAP guidelines.
You have HER2-amplified breast cancer according to most recent biopsy (local testing permitted).
Metastatic disease must be measurable or evaluable by RECIST (v1.1).
You have received prior TDM1 therapy.
You have received 5 or fewer chemotherapy regimens for breast cancer.
You have a platelet count of at least 100,000 cells/mm3 (50 x 10^9/L).
Patients with hemoglobin >9.0 g/dL are eligible.
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Conditions
Cancer Related
Treatments