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Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer
Sponsor: Thomas Hatschek
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2014-11
Completion Date
2029-02
Last Updated
2020-08-13
Healthy Volunteers
No
Interventions
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
trastuzumab emtansin
trastuzumab emtansine 3.6 mg/kg IV, repeated every 3 weeks, 6 courses
Locations (7)
Dept. of Oncology, Örebro University Hospital
Örebro, Närke, Sweden
Dept. of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
Dept. of Oncology, Skåne University Hospital
Lund, Sweden
Dept. of Oncology, Karolinska University Hospital
Stockholm, Sweden
Dept. of Oncology, Sundsvall Hospital
Sundsvall, Sweden
Dept. of Oncology, University Hospital of Umeå
Umeå, Sweden
Dept. of Oncology, Uppsala University Hospital
Uppsala, Sweden