NCT02568839

Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer

PREDIX HER2 - Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer. Part of a Platform of Translational Phase II Trials Based on Molecular Subtypes

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Thomas Hatschek · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-11-01
• Primary completion: 2019-02-01
• Completion: 2029-02-01
• First posted: 2015-10-06
• Last updated: 2020-08-13

Locations

7 sites across 1 country: Sweden