CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
trastuzumab +1 morebiological
Likely dose
Trastuzumab 4 mg/kg IV on day 1, then 2 mg/kg IV weekly; Erlotinib 100 mg daily (escalating to 150 mg daily after week 3 if tolerated)AI-extracted
Key inclusion· 6
  • ✓Women aged >18 years
  • ✓Histologically documented metastatic breast cancer
  • ✓HER2 positive confirmed by FISH
  • ✓Phase II: measurable disease >2 cm (or >1 cm on spiral CT)
Key exclusion· 2
  • ✕Phase II only: prior cytotoxic chemotherapy for metastatic disease
  • ✕Phase II only: prior Herceptin for metastatic disease (prior adjuvant allowed)

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

Search/NCT00033514
NCT00033514Phase 2Completed
CompareCT.gov

Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression

Jonsson Comprehensive Cancer Center·interventional·Posted Jan 27, 2003·Updated Oct 8, 2020

In Brief

A Phase 2 clinical trial evaluating trastuzumab and erlotinib hydrochloride for Breast Cancer. Completed, enrolled 27 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartAug 1, 2001
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 23.4 years ago

Interventions

trastuzumabbiological

Day 1 4mg/kg IV 2 mg/kg IV weekly.

erlotinib hydrochloridedrug

100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.