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

NCT02073487 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-09-22

Study results available
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Summary

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.

Conditions

Interventions

DRUG

T-DM1

antibody-drug conjugate of trastuzumab and emtansine

DRUG

Trastuzumab

anti-Her2 monoclonal antibody

DRUG

Lapatinib

Dual tyrosine kinase inhibitor (HER2 and EGFR)

DRUG

Abraxane

albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.

DRUG

Paclitaxel

chemotherapy - microtubule inhibitor

DRUG

Pertuzumab

anti-HER2 monoclonal antibody

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Jenny C Chang, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT02073487 on ClinicalTrials.gov