CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Pertuzumab +1 moredrug
Likely dose
Pertuzumab 840 milligramsfrom 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/NCT02536339
NCT02536339Phase 2Completed
CompareCT.gov

An Open-Label, Single-Arm, Phase II Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Central Nervous System Progression Post-Radiotherapy in Patients With HER2-Positive Metastatic Breast Cancer (PATRICIA)

Genentech, Inc.·interventional·Posted Aug 31, 2015·Updated Dec 7, 2021

In Brief

A Phase 2 clinical trial evaluating Pertuzumab and Trastuzumab for Metastatic Breast Cancer. Completed, enrolled 40 participants across 16 sites.

Detailed Summary

This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 31, 2015
Enrollment StartDec 16, 2015
Primary CompletionMay 1, 2019
Study CompletionDec 29, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.8 years ago

Interventions

Pertuzumabdrug

Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Trastuzumabdrug

Participants will receive trastuzumab at a dose of 6 milligrams per kilogram (mg/kg) of body weight once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.