CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
paclitaxel +4 moredrug
Likely dose
Not stated in 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/NCT00951665
NCT00951665Phase 2Completed
CompareCT.gov

A Phase Ib-IIa, Open-label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of Trastuzumab Emtansine, Paclitaxel and Pertuzumab Administered Intravenously to Patients With Her2-positive, Locally Advanced or Metastatic Breast Cancer

Genentech, Inc.·interventional·Posted Aug 4, 2009·Updated Jun 24, 2016

In Brief

A Phase 2 clinical trial evaluating paclitaxel, pertuzumab [Perjeta], and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 107 participants across 5 sites.

Detailed Summary

This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (HER2-positive), locally advanced or metastatic breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 4, 2009
Enrollment StartAug 1, 2009
Primary CompletionFeb 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.9 years ago

Interventions

paclitaxeldrug

Intravenous repeating dose

pertuzumab [Perjeta]drug

Intravenous repeating dose

trastuzumab emtansine [Kadcyla]drug

Intravenous escalating dose

paclitaxeldrug

Intravenous escalating dose

trastuzumab emtansine [Kadcyla]drug

Intravenous repeating dose