CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 1,206 enrolled
Drug / intervention
bevacizumab +5 morebiological
Likely dose
bevacizumab 15 mg/kgfrom 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/NCT00408408
NCT00408408Phase 3Unknown

A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens

NSABP Foundation Inc·interventional·Posted Dec 7, 2006·Updated Sep 18, 2017

In Brief

A Phase 3 clinical trial evaluating bevacizumab, capecitabine, and 4 other interventions for Breast Cancer. Targeting 1,206 participants across 442 sites in 3 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer. PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.

Study Details

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

Timeline

Phase 3UnknownOverdue
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 7, 2006
Enrollment StartNov 1, 2006
Primary CompletionMar 1, 2011
Study CompletionMar 1, 2018
TodayJul 1, 2026
Enrollment to primary: 4.3 yearsPosted 19.6 years ago

Interventions

bevacizumabbiological

15 mg/kg IV

capecitabinedrug

825 mg/m2 orally

cyclophosphamidedrug

600 mg/m2 IV

docetaxeldrug

100 mg/m2 IV

doxorubicin hydrochloride (Adriamycin)drug

60 mg/m2 IV

gemcitabine hydrochloridedrug

1000 mg/m2 IV