A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer

Sponsor: Japan Breast Cancer Research Group
Study ID: NCT02514681
Phase: PHASE3
Status: Completed

Conditions

HER2-positive Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex: FEMALE
Age: 20 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Trastuzumab — DRUG
Pertuzumab — DRUG
Docetaxel — DRUG
Paclitaxel — DRUG
Nab-paclitaxel — DRUG
Vinorelbine — DRUG
Eribulin — DRUG
Capecitabine — DRUG
Gemcitabine — DRUG

Study Details

The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer patients for previously treated with pertuzumab

Key Dates

Start date: Aug 1, 2015
Status verified: Sep 2025
Primary completion: Dec 31, 2018
Completion: Aug 10, 2022

Study Design

Enrollment: 226 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Active Comparator: Trastuzumab + chemotherapy
Trastuzumab + chemotherapy Chemotherapy regimen is chosen from the following; Docetaxel, Paclitaxel, nab-paclitaxel ,Vinorelbine, Eribulin, Capecitabine or Gemcitabine
Experimental: Trastuzumab+ pertuzumab + chemotherapy
Trastuzumab+ pertuzumab + chemotherapy Chemotherapy regimen is chosen from the following; Docetaxel, Paclitaxel, nab-paclitaxel, Vinorelbine, Eribulin, Capecitabine or Gemcitabine

Primary Outcome Measure

Progression-free survival (assessed by investigators) [ Time Frame: 4 years ]