CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 104 enrolled
Drug / intervention
Doxorubicin +3 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/NCT00546156
NCT00546156Phase 2Completed

A Phase II Study of Preoperative Dose-dense (dd) Doxorubicin and Cyclophosphamide (AC) Followed by Paclitaxel (T) With Bevacizumab in ER+ and/or PR+, HER2-negative Operable Breast Cancer

Ian E. Krop, MD, PhD·interventional·Posted Oct 18, 2007·Updated May 18, 2021

In Brief

A Phase 2 clinical trial evaluating Doxorubicin, Cyclophosphamide, and 2 other interventions for Breast Cancer. Completed, enrolled 104 participants across 4 sites.

Detailed Summary

Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment of ER+ or PR+ breast cancer. In this trial, the standard chemotherapy is being combined with bevacizumab. Bevacizumab is an antibody which works differently from the way other chemotherapy drugs work. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors by binding to a substance found on cancer cells called VEGF (vascular endothelial growth factor). Bevacizumab is approved by the FDA for the treatment of colorectal cancer and lung cancer. However, it is not approved for the treatment of breast cancer. Another goal of this research is to determine whether we can develop a way to identify tumors that will respond well to this study treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2007
Enrollment StartOct 1, 2007
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.7 years ago

Interventions

Doxorubicindrug

Standard chemotherapy regimen

Cyclophosphamidedrug

Standard chemotherapy regimen

Paclitaxeldrug

Standard chemotherapy regimen

Bevacizumabdrug

One intravenous dose given followed 2 weeks later with standard chemotherapy drugs and bevacizumab given intravenously in 8 two-week cycles.