Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT02073487
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • T-DM1 — DRUG
    antibody-drug conjugate of trastuzumab and emtansine
  • Trastuzumab — DRUG
    anti-Her2 monoclonal antibody
  • Lapatinib — DRUG
    Dual tyrosine kinase inhibitor (HER2 and EGFR)
  • Abraxane — DRUG
    albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.
  • Paclitaxel — DRUG
    chemotherapy - microtubule inhibitor
  • Pertuzumab — DRUG
    anti-HER2 monoclonal antibody

Study Details

This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L)followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer.

Key Dates

Start date
Feb 28, 2014
Status verified
Aug 2021
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: T-DM1 + Lapatinib + Abraxane
    T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.
  • Active Comparator: Trastuzumab + Pertuzumab + Paclitaxel
    Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.

Primary Outcome Measure

Pathological Complete Response (pCR) RCB-0 or RCB-1 [ Time Frame: From date of randomization until the date of surgery, approximately 16 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-
Houston Methodist Hospital WillowbrookHoustonTexas77070-
Houston Methodist Hospital Sugar LandSugar LandTexas77479-

Find similar trials in Houston, TX

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

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