Overview

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

Status:
Withdrawn

Trial end date:
2019-04-01

Target enrollment:

Participant gender:

Summary

This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.

Phase:

Phase 3

Details

Lead Sponsor:

iOMEDICO AG

Collaborators:

Amgen
Arbeitsgemeinschaft fur Internistische Onkologie

Treatments:

Docetaxel
Pertuzumab
Trastuzumab
Vinblastine
Vinorelbine