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Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer

NCT02568839 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2020-08-13

No results posted yet for this study

Summary

The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years.

A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.

Conditions

  • Early-Stage Breast Carcinoma
  • HER-2 Positive Breast Cancer

Interventions

DRUG

docetaxel + trastuzumab sc + pertuzumab

docetaxel 75-100 mg IV + trastuzumab sc 5 ml (600 mg) SC + pertuzumab 840 mg IV starting dose, subsequently 420 mg IV, repeated every 3 weeks, 6 courses

DRUG

trastuzumab emtansin

trastuzumab emtansine 3.6 mg/kg IV, repeated every 3 weeks, 6 courses

Sponsors & Collaborators

  • Thomas Hatschek

    lead OTHER

Principal Investigators

  • Thomas Hatschek, Assoc prof · Breast-sarcoma unit, Dept. of Oncology, Karolinska university hospital

  • Jonas Bergh, Professor · Dept. of Oncology-Pathology, Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2019-02-28
Completion
2029-02-28

Countries

  • Sweden

Study Locations

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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 NCT02568839 on ClinicalTrials.gov