CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 88 enrolled
Drug / intervention
Trastuzumab +2 moredrug
Likely dose
Trastuzumab 8 mg/kgfrom 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/NCT01937117
NCT01937117Phase 2Active

A Phase 2 Clinical Trial Assessing the Correlation of Early Changes in Standardized Uptake Value (SUV) on Positron Emission Tomography (PET) With Pathological Complete Response (pCR) to Pertuzumab and Trastuzumab in Patients With Primary Operable HER2-Positive Breast Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Sep 9, 2013·Updated Jul 1, 2025

In Brief

A Phase 2 clinical trial evaluating Positron emission tomography (PET), Trastuzumab, and 1 other intervention for Breast Cancer. Active but no longer recruiting, targeting 88 participants across 10 sites.

Detailed Summary

This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2ActiveOverdue
2014201520162017201820192020202120222023202420252026
First PostedSep 9, 2013
Enrollment StartJan 30, 2014
Primary CompletionMar 20, 2018
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.8 years ago

Interventions

Positron emission tomography (PET)procedure

PET will be performed at baseline and on day 15

Trastuzumabdrug

8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV

Pertuzumabdrug

840 mg as a loading dose, then 420 mg every 3 weeks, IV