Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03135171
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab — DRUG
    All dose levels will receive 8 mg/kg loading dose for cycle 1, followed by 6 mg/kg in subsequent cycles, every 3 weeks.
  • Pertuzumab — DRUG
    Dose Levels two and three will receive 840 mg loading dose for cycle 1, followed by 420 mg in subsequent cycles, every 3 weeks.
  • Tocilizumab — DRUG
    Tocilizumab 4-8 mg/kg, administered intravenously every three weeks

Study Details

The goal in this Phase 1 dose-escalation trial of the anti-IL-6R monoclonal antibody tocilizumab in combination with trastuzumab and pertuzumab in subjects with metastatic HER2 positive breast cancer is to determine the safety, tolerability and recommended Phase 2 dose of tocilizumab given with trastuzumab and pertuzumab every 3 weeks.

Key Dates

Start date
Jul 26, 2017
Status verified
Sep 2021
Primary completion
Mar 16, 2020
Completion
Mar 20, 2020

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab, Pertuzumab and Tocilizumab

Primary Outcome Measure

Recommended Phase II Dose of Tocilizumab [ Time Frame: 10 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Yale UniversityNew HavenNew York06520-

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Chicago· Chicago, ILUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIYale University· New Haven, NY

Related Studies