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Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00028990
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 9, 2012
National Cancer Institute (NCI)
North Central Cancer Treatment Group
NCIC Clinical Trials Group
NSABP Foundation Inc
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer.

PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: bevacizumab Drug: Paclitaxel Phase 3

Detailed Description:


  • Compare the time to treatment failure in patients with locally recurrent or metastatic breast cancer treated with paclitaxel with or without bevacizumab.
  • Compare the objective response rate, duration of response, overall survival, and time to progression in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease-free interval (no more than 24 months vs more than 24 months), number of metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy (yes vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 followed by bevacizumab IV over 30-90 minutes on days 1 and 15.
  • Arm II: Patients receive paclitaxel as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and on day 1 of weeks 17 and 33.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued for this study within 31 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer
Study Start Date : December 2001
Actual Primary Completion Date : November 2006
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Paclitaxel + Bevacizumab Drug: bevacizumab
10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle
Other Name: Avastin

Drug: Paclitaxel
90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest

Active Comparator: Paclitaxel Drug: Paclitaxel
90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Locally recurrent disease that is not amenable to surgical resection with curative intent OR
  • Metastatic disease
  • No HER-2-overexpressing (3+) breast cancer unless previously treated with trastuzumab (Herceptin)

    • Unknown HER-2 status allowed provided herceptin-based therapy inappropriate or not indicated
  • No prior or radiologic evidence of CNS metastases, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No prior bleeding diathesis


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN for known liver involvement)
  • PT/PTT no greater than 1.5 times normal
  • INR no greater than 1.5 times normal


  • Creatinine no greater than 2.0 mg/dL
  • No proteinuria by dipstick urinalysis
  • Trace proteinuria allowed
  • Proteinuria less than 500 mg by 24-hour urine collection if proteinuria at least 1+ by urinalysis


  • No clinically significant cardiovascular disease
  • No myocardial infarction within the past 12 months
  • No unstable angina
  • No prior deep vein thrombosis
  • No grade 2 or greater peripheral vascular disease
  • No uncontrolled congestive heart failure
  • No uncontrolled hypertension (systolic blood pressure greater than 170 mmHg and diastolic blood pressure greater than 95 mm Hg)
  • No prior cerebrovascular accident


  • No prior pulmonary embolism


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception
  • No history of seizures
  • No non-healing wound or fracture
  • No hypersensitivity to paclitaxel, Cremophor EL, Chinese hamster ovary cell products, or other recombinant human antibodies
  • No active infection requiring parenteral antibiotics


Biologic therapy:

  • See Disease Characteristics


  • No prior chemotherapy for locally recurrent or metastatic breast cancer
  • At least 12 months since prior adjuvant or neoadjuvant taxane therapy
  • At least 3 weeks since prior adjuvant chemotherapy

Endocrine therapy:

  • At least 3 weeks since prior hormonal therapy for locally recurrent or metastatic breast cancer


  • At least 3 weeks since prior radiotherapy
  • No prior radiotherapy to only site of disease
  • No concurrent local radiotherapy for pain control or life-threatening situations (e.g, superior vena cava syndrome, spinal cord compression, or CNS metastases)


  • At least 4 weeks since prior major surgical procedure except placement of vascular access device or breast biopsy
  • At least 7 days since prior minor surgical procedure, including placement of an access device or fine needle aspiration


  • At least 10 days since prior anticoagulant therapy (low-dose anticoagulant therapy to maintain patency of a vascular access device allowed)
  • At least 10 days since prior and no concurrent daily aspirin (more than 325 mg/day) or other non-steroidal anti-inflammatory medication known to inhibit platelet function
  • No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028990

Show Show 30 study locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
North Central Cancer Treatment Group
NCIC Clinical Trials Group
NSABP Foundation Inc
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Study Chair: Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center
OverallOfficial: Robin Zon, MD Elkhart General Hospital
Study Chair: Edith A. Perez, MD Mayo Clinic
Study Chair: Tamara N. Shenkier, MD British Columbia Cancer Agency
Study Chair: Melody A. Cobleigh, MD Rush University Medical Center
Publications of Results:
Miller KD, Wang M, Gralow J, et al.: A randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer: a trial coordinated by the Eastern Cooperative Oncology Group (E2100). [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-3, 2005.

Other Publications:
Gray R, Giantonio BJ, O'Dwyer PJ, et al.: The safety of adding angiogenesis inhibition into treatment for colorectal, breast, and lung cancer: the Eastern Cooperative Oncology Group's (ECOG) experience with bevacizumab (anti-VEGF). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-825, 2003.

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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00028990    
Other Study ID Numbers: CDR0000069156
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: January 2010
Keywords provided by Eastern Cooperative Oncology Group:
stage IV breast cancer
recurrent breast cancer
male breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors