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Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer

NCT00281528 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2019-11-22

Study results available
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Summary

This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

Conditions

  • Breast Neoplasms
  • Neoplasm Metastasis

Interventions

DRUG

ABI-007 (Abraxane)

30 minute infusions

DRUG

bevacizumab

infusions

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Andrew Seidman, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-01
Primary Completion
2010-07-01
Completion
2011-03-01

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00281528 on ClinicalTrials.gov