CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 394 enrolled
Drug / intervention
Bevacizumab +4 morebiological
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/NCT00601900
NCT00601900Phase 3Completed

Endocrine Therapy With or Without Anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865) for Women With Hormone Receptor-Positive Advanced Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Jan 28, 2008·Updated May 23, 2025

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Laboratory Biomarker Analysis, and 3 other interventions for Invasive Breast Carcinoma and 3 related conditions. Completed, enrolled 394 participants across 522 sites in 2 countries.

Detailed Summary

This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartSep 24, 2008
Primary CompletionJun 30, 2014
Study CompletionMay 1, 2025
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.4 years ago

Interventions

Bevacizumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Letrozoledrug

Given PO

Questionnaire Administrationother

Ancillary studies

Tamoxifen Citratedrug

Given PO