Trastuzumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+1 MoreTrastuzumab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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: Drug
Trastuzumab 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.