HER-2 Positive Breast Cancer Clinical Trial
Official title:
PREDIX HER2 - Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes
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.
Patients with HER2-positive tumors >20 mm or verfied regional lymph node metastases are
randomized to either arm A, the combination of docetaxel, trastuzumab sc (Herceptin SC®) and
pertuzumab (Perjeta®) or arm B, trastuzumab emtansin (Kadcyla®). Switch to the opposite
treatment is performed in case of lack of response after evaluations with mammography and
ultrasound, alternatively MRI breast after the 2nd, 4th and 6th course of treatment.
Postoperative treatment, trastuzumab, radiotherapy, eventual endocrine treatment) according
to standard guidelines. Structured follow-up visits yearly for five years, including
reporting of persistent treatment-related toxicity, HRQoL, recurrence and death.
The trial contains also a translational subprotocol:
1. PET-CT using FDG, confined to the chest, is performed before start, and after the 2nd
and 6th course (functional imaging, optional).
2. Core biopsies from the tumor are collected before start and after the 2nd course of
treatment. If residual tissue is available, samples are collected from the surgical
sample
3. Blood samples are collected repeatedly during the ongoing treatment and yearly follow-up
4. FNAs from metastases in case of recurrence during follow-up
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