Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer

Part of paid clinical trials in Dallas, Texas.

Sponsor
US Oncology Research
Study ID
NCT03379428
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab — DRUG
    8 mg/kg loading dose (first dose), followed by 6 mg/kg every 3 weeks, administered intravenously (IV)
  • Ibrutinib 560 mg — DRUG
    560 mg by mouth daily
  • Ibrutinib 840 mg — DRUG
    840 mg by mouth daily
  • Ibrutinib 420 mg — DRUG
    420 mg by mouth daily

Study Details

This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with trastuzumab administered through the vein, in patients with HER2-amplified Metastatic Breast Cancer that has gotten worse after prior therapy with ado-trastuzumab emtansine (T-DM1).

Key Dates

First listed
Dec 20, 2017
Start date
Nov 29, 2017
Status verified
Dec 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab plus Ibrutinib 560 mg
    In Phase I, starting dose of Ibrutinib will be 560 mg orally per day. 3 patients will be enrolled first. If none of these have DLTs, 3 new patients will be enrolled at the next higher Ibrutinib dose level (840 mg orally per day). If 1 of these 3 patients have a DLT, expand this arm to 6 patients. If 2 or more of these 6 patients have a DLT, enroll 3 patients in lower dose lever (420 mg).
  • Experimental: Trastuzumab plus Ibrutinib 840 mg
    If no patients in 560 mg arm have DLTs, this arm will be opened in Phase I to see how this higher dose is tolerated.
  • Experimental: Trastuzumab plus Ibrutinib 420 mg
    If 2 or more patients in 560 mg arm have DLTs, this arm will be opened in Phase I to see how this lower dose is tolerated.
  • Experimental: Phase II- Trastuzumab plus Maximum Tolerated Dose
    Maximum tolerated dose from Phase I will be used here in Phase II.

Primary Outcome Measure

Phase I: Maximum Tolerated Dose [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
10 sites incl TX, WA, VA, and NVDallasTexas75246-

Find similar trials in Dallas, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
10 sites incl TX, WA, VA, and NV· Dallas, TX

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