CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
cisplatin +4 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/NCT00580333
NCT00580333Phase 2Completed

A Phase II Trial of Preoperative Cisplatin and Bevacizumab in Estrogen Receptor (ER) Negative, Progesterone (PR) Negative, Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

Massachusetts General Hospital·interventional·Posted Dec 24, 2007·Updated May 26, 2021

In Brief

A Phase 2 clinical trial evaluating cisplatin, bevacizumab, and 3 other interventions for Breast Cancer. Completed, enrolled 51 participants across 3 sites.

Detailed Summary

The purpose of this study is to find out what effect taking cisplatin in combination with bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer. Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be effective and have manageable side effects. Bevacizumab is an antibody, which is a protein that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2010
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.5 years ago

Interventions

cisplatindrug

Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

bevacizumabdrug

Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

doxorubicindrug

Postoperative: Given intravenously for four 2-week cycles

cyclophosphamidedrug

Postoperative: Given intravenously for four two-week cycles

paclitaxeldrug

Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)