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

NCT03379428 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-12-06

No results posted yet for this study

Summary

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).

Conditions

  • Breast Neoplasms
  • Malignant Neoplasm of Breast

Interventions

DRUG

Trastuzumab

8 mg/kg loading dose (first dose), followed by 6 mg/kg every 3 weeks, administered intravenously (IV)

DRUG

Ibrutinib 560 mg

560 mg by mouth daily

DRUG

Ibrutinib 840 mg

840 mg by mouth daily

DRUG

Ibrutinib 420 mg

420 mg by mouth daily

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • US Oncology Research

    lead INDUSTRY

Principal Investigators

  • Joyce O'Shaughnessy, MD · US Oncology Research/McKesson Specialty Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03379428 on ClinicalTrials.gov