At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 79 enrolled

Drug / intervention

Pertuzumabdrug

Likely dose

Pertuzumab 420 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02491892

NCT02491892Phase 2Completed

Compare CT.gov

Open-Label, Phase II, Multicenter, Randomized Study of Efficacy and Safety for Two Different Doses of a Recombinant Humanized Antibody to HER2 (rhuMAb 2C4) Administered Every 3 Weeks to Patients With Metastatic Breast Cancer With Low Expression of HER2

Hoffmann-La Roche·interventional·Posted Jul 8, 2015·Updated Aug 25, 2015

In Brief

A Phase 2 clinical trial evaluating Pertuzumab for Breast Cancer. Completed, enrolled 79 participants across 18 sites in 8 countries.

Detailed Summary

This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesAustralia, Belgium, Finland, Germany, Italy, Netherlands, Spain, United Kingdom

Collaborators--

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2003

Primary CompletionApr 2005

First PostedJul 2015

TodayJul 2026

First PostedJul 8, 2015

Enrollment StartFeb 1, 2003

Primary CompletionApr 1, 2005

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 11.0 years ago

Interventions

Pertuzumabdrug

Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.