A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2019

Primary Completion Date

April 30, 2019

Study Completion Date

April 30, 2019

Conditions
Advanced Breast CancerHER2-positive Breast Cancer
Interventions
DRUG

Trastuzumab

"administered as combined therapy with pertuzumab and vinorelbine or docetaxel.~Trastuzumab will be administered as an IV loading dose of 8 milligrams per kilogram (mg/kg) on day 1 of cycle 1 (1 cycle length = 21 days), and 6 mg/kg Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."

DRUG

Pertuzumab

"administered as combined therapy with Kanjinti® and vinorelbine or docetaxel.~Pertuzumab will be administered as an IV loading dose of 840 milligrams (mg) on day 1 of cycle 1 (1 cycle length = 21 days), and 420 mg Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."

DRUG

Vinorelbine

"administered as combined therapy with Kanjinti® and pertuzumab.~Vinorelbine will be administered as an IV dose of 25 milligrams per kilogram (mg/kg) on days 1 and 8 of cycle 1 (1 cycle length = 21 days), and 25mg/kg up to 30 mg/kg (as per treating physician discretion) Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."

DRUG

Docetaxel

"administered as combined therapy with Kanjinti® and pertuzumab.~Docetaxel will be administered as an IV dose of 75 milligrams per square meter (mg/m\^2) on day 1 of cycle 1 (1 cycle length = 21 days), and 75 mg/m\^2 (up to 100 mg/m\^2 as per treating physician discretion) Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."

Trial Locations (1)

79106

iOMEDICO AG, Freiburg im Breisgau

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Arbeitsgemeinschaft fur Internistische Onkologie

OTHER

collaborator

Amgen

INDUSTRY

lead

iOMEDICO AG

INDUSTRY