CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 215 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/NCT00856492
NCT00856492Phase 2Completed

A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A)and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) as Neoadjuvant Therapy For Inflammatory and Locally Advanced HER-2/NEU Negative Breast Cancer

SWOG Cancer Research Network·interventional·Posted Mar 5, 2009·Updated Jun 27, 2017

In Brief

A Phase 2 clinical trial evaluating bevacizumab, pegfilgrastim, and 3 other interventions for Breast Cancer. Completed, enrolled 215 participants across 366 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2009
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 17.3 years ago

Interventions

bevacizumabbiological

Given IV

pegfilgrastimbiological

Given subcutaneously

cyclophosphamidedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

paclitaxel albumin-stabilized nanoparticle formulationdrug

Given IV