CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Bevacizumab +2 morebiological
Likely dose
Erlotinib hydrochloride (OSI-774) orally plus bevacizumab IV; specific doses not stated in published recordAI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed stage IV breast cancer with stable or progressive disease after therapy
  • Measurable disease: ≥20 mm with conventional imaging or ≥10 mm with spiral CT
  • Prior treatment: 1-2 conventional chemotherapy regimens for metastatic breast cancer; unlimited prior hormonal or immunotherapy; if HER2+ prior trastuzumab required
  • ECOG performance status ≤2 (Karnofsky ≥60%)
Key exclusion· 8
  • Any prior EGFR-targeting therapy (e.g., ZD1839, C225)
  • Any prior VEGF/KDR inhibitors (e.g., VEGF Trap, Su5416, Su6668, ZD6474, PTK757, IMC-1CII)
  • CNS disease including brain metastases, primary brain tumor, uncontrolled seizures, or history of stroke
  • Corneal abnormalities (dry eye, Fuch's dystrophy, abnormal slit-lamp exam, or abnormal Schirmer test)

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

Search/NCT00054132
NCT00054132Phase 2Completed

A Phase II Study of OSI-774 in Combination With Bevacizumab in Patients With Stage IV Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Feb 6, 2003·Updated Jul 24, 2017

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Erlotinib Hydrochloride, and 1 other intervention for Recurrent Breast Carcinoma and Stage IV Breast Cancer. Completed, enrolled 38 participants across 2 sites.

Detailed Summary

This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving erlotinib hydrochloride and bevacizumab may be an effective treatment for breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2003
Enrollment StartDec 1, 2002
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 12.3 yearsPosted 23.4 years ago

Interventions

Bevacizumabbiological

Given IV

Erlotinib Hydrochloridedrug

Given PO

Laboratory Biomarker Analysisother

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