T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
Jenny C. Chang, MD
Study ID
NCT02073916
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • T-DM1 — DRUG
    antibody-drug conjugate of trastuzumab and emtansine
  • Lapatinib — DRUG
    Dual tyrosine kinase inhibitor (HER2 and EGFR)
  • Abraxane — DRUG
    albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor

Study Details

This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.

Key Dates

Start date
Oct 31, 2013
Status verified
Apr 2019
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

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

Arms

  • Experimental: T-DM1 + Lapatinib + Abraxane
    T-DM1 with Laptinib followed by Abraxane

Primary Outcome Measure

Maximum Tolerable Dose [ Time Frame: approximately 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Houston Methodist Hospital· Houston, TX

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