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Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer

NCT01891357 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-09-17

Study results available
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Summary

The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks.

Conditions

  • Carcinoma, Ductal, Breast

Interventions

PROCEDURE

Biopsy before and after three weeks of study treatment

Core biopsies for histological analyses, to be analysed by the central pathology

DRUG

paclitaxel

DRUG

lapatinib

DRUG

trastuzumab

Sponsors & Collaborators

Principal Investigators

  • Mathias Warm, MD · Krankenhaus Köln Holweide

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-11-16
Completion
2016-11-16

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01891357 on ClinicalTrials.gov