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

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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