CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Avastin +1 moredrug
Likely dose
Bevacizumab 15 mg/kg IV every three weeks plus aromatase inhibitor (letrozole 2.5 mg daily, anastrozole 1 mg daily, or exemestane 25 mg daily) or tamoxifen 20 mg dailyAI-extracted
Key inclusion· 9
  • Cytologically or histologically confirmed breast cancer that is estrogen receptor or progesterone receptor positive and locally advanced and/or metastatic
  • Female, age ≥19 years
  • ECOG performance status <2
  • Prior response to first or second-line hormonal therapy (partial/complete response >6 months or stable disease >6 months per RECIST), now resistant to that hormone therapy, and must continue current hormone therapy
Key exclusion· 13
  • De novo (primary) resistance to hormone therapy
  • Brain metastases
  • History of thrombosis in the past year, including transient ischemic attack
  • Uncontrolled hypertension (>150/100 mmHg)

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

Search/NCT00240071
NCT00240071Phase 2Completed

The Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Metastatic Breast Cancer Patients Previously Responsive to Hormonal Therapy: A Phase II Trial

University of Alabama at Birmingham·interventional·Posted Oct 17, 2005·Updated Oct 30, 2019

In Brief

A Phase 2 clinical trial evaluating Avastin and Hormonal therapy for Metastatic Breast Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2005
Enrollment StartOct 1, 2005
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.7 years ago

Interventions

Avastindrug

All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.

Hormonal therapydrug

aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)