NCT02682693 - Denosumab as an add-on Neoadjuvant Treatment (GeparX) | Biotech Hunter

Enrollment

780

Participants

Timeline

Start Date

February 13, 2017

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2020

Conditions

Breast Cancer Female NOSTubular Breast Cancer Stage IIMucinous Breast Cancer Stage IIInvasive Ductal Breast CancerHER2 Positive Breast CancerInflammatory Breast CancerTubular Breast Cancer Stage III

Interventions

DRUG

Denosumab

Denosumab 120 mg every 4 weeks for 6 cycles

DRUG

nab-Paclitaxel

nab-paclitaxel 125 mg/m² weekly for 12 weeks or at day 1,8 q22 for 4 cycles (12 weeks)

DRUG

Epirubicin

Epirubicin 90 mg/m² every 2 or 3 weeks for 4 times

DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m² every 2 or 3 weeks for 4 times

DRUG

Carboplatin

Carboplatin AUC 2 weekly in parallel to nab-Paclitaxel

DRUG

Trastuzumab

Trastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all chemotherapy cycles

DRUG

Pertuzumab

Pertuzumab 420 (840) mg every 3 weeks simultaneously to all chemotherapy cycles

Trial Locations (1)

10113

Charité Campus Mitte, Berlin