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

NCT00028990 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000069156E2100NCCTG-E2100CAN-NCIC-MAC3NSABP-E2100
• Study Type: interventional
• Target: 722
• Locations: 2 countries
• Sites: 30

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Assessed every 3 months for 2 years, then every 6 months for 3 years

Study Arms (2)

Paclitaxel + Bevacizumab

ACTIVE COMPARATOR

Drug: bevacizumab; Drug: Paclitaxel

Paclitaxel

ACTIVE COMPARATOR

Drug: Paclitaxel

Interventions

bevacizumab DRUG

10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle

Also known as: Avastin

Paclitaxel + Bevacizumab

Paclitaxel DRUG

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

Paclitaxel; Paclitaxel + Bevacizumab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Male or female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No prior bleeding diathesis Hepatic: * 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 Renal: * 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 Cardiovascular: * 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 Pulmonary: * No prior pulmonary embolism Other: * 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * 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 Radiotherapy: * 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) Surgery: * 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 Other: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• North Central Cancer Treatment Group: collaborator
• NCIC Clinical Trials Group: collaborator
• NSABP Foundation Inc: collaborator

Study Sites (30)

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (6)

• 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.

  BACKGROUND

• Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8. doi: 10.1200/JCO.2008.16.1612.

  PMID: 18824714 RESULT

• Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113.

  PMID: 18160686 RESULT

• Cella D, Wang M, Wagner L, Miller K. Survival-adjusted health-related quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab versus paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100). Breast Cancer Res Treat. 2011 Dec;130(3):855-61. doi: 10.1007/s10549-011-1725-6. Epub 2011 Aug 27.

  PMID: 21874312 RESULT

• 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.

  RESULT

• Miller KD. E2100: a phase III trial of paclitaxel versus paclitaxel/bevacizumab for metastatic breast cancer. Clin Breast Cancer. 2003 Feb;3(6):421-2. doi: 10.3816/CBC.2003.n.007. No abstract available.

  PMID: 12636887 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Bevacizumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Kathy Miller, MD

  Indiana University Melvin and Bren Simon Cancer Center

  STUDY CHAIR

• Robin Zon, MD

  Elkhart General Hospital

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: January 29, 2002
• Primary Completion: November 1, 2006
• Study Completion: May 1, 2009
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CA (2); US (28)