A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00356681

Purpose

To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.

Condition	Intervention	Phase
Breast Neoplasms Breast Tumors Breast Cancer Locally Recurrent and Metastatic Breast Cancer	Drug: AMG 706 placebo Drug: Bevacizumab Drug: AMG 706	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Bevacizumab Motesanib

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Objective response rate, measured radiologically and assessed by an independent review committee. [ Time Frame: Last patient enrolled + 16 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events. [ Time Frame: >24 weeks ] [ Designated as safety issue: No ]

Enrollment:	282
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Blinded AMG 706 placebo	Drug: AMG 706 placebo AMG 706 placebo 125mg QD until disease progression, consent withdrawal or unacceptable toxicity
B: Active Comparator Blinded AMG 706	Drug: AMG 706 AMG 706 125mg PO QD until disease progression, consent withdrawal or unacceptable toxicity
C: Experimental Open-label bevacizumab	Drug: Bevacizumab Bevacizumab 10 mg/kg IV every 14 days until disease progression, consent withdrawal or unacceptable toxicity

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
Measurable disease by RECIST guidelines.
Tumor (primary or metastatic) must be HER2 negative.
Adequate organ and hematologic function. Exclusion:
Taxane treatment within 12 months prior to registration.
Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
Current or prior history of central nervous system metastases.
Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
History of arterial or venous thrombosis within 1 year prior to registration.
History of bleeding diathesis or bleeding within 14 days of registration.
Uncontrolled hypertension (systolic >145 mmHg; diastolic >85 mmHg).
Clinically significant cardiac disease within 12 months of registration.
Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
Prior treatment with VEGFr targeted therapies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356681

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Locations

United States, California
Research Site
Lancaster, California, United States
Research Site
Santa Maria, California, United States
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Encinitas, California, United States
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Santa Barbara, California, United States
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Northridge, California, United States
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Oxnard, California, United States
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Santa Barbara, California, United States
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Alhambra, California, United States
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San Diego, California, United States
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Redondo Beach, California, United States
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Long Beach, California, United States
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Pomona, California, United States
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Los Angeles, California, United States
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Bakersfield, California, United States
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Burbank, California, United States
United States, Connecticut
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Menden, Connecticut, United States
United States, Florida
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Gainesville, Florida, United States
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Orlando, Florida, United States
United States, Georgia
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Lawrenceville, Georgia, United States
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Marietta, Georgia, United States
United States, Indiana
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Terre Haute, Indiana, United States
United States, Maryland
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Chevy Chase, Maryland, United States
United States, Nevada
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Las Vegas, Nevada, United States
United States, New Mexico
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Albuquerque, New Mexico, United States
United States, North Carolina
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Charlotte, North Carolina, United States
Australia
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Herston, Australia
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Hobart, Australia
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Box Hill, Australia
Australia, New South Wales
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North Sydney, New South Wales, Australia
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East Ringwood, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
Canada, Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, New Brunswick
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Moncton, New Brunswick, Canada
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Moncton, New Brunswick, Canada
Canada, Ontario
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Toronto, Ontario, Canada
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Brampton, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Québec, Quebec, Canada
France
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Angers, France
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Paris, France
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Marseille, France
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Toulon Cedex, France
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Toulon Cedex, France
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La Roche Sur Yon, France
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Toulouse, France
Germany
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München, Germany
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Kiel, Germany
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München, Germany
Hong Kong
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Wanchai, Hong Kong
Hungary
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Budapest, Hungary
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Gyor, Hungary
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Nyiregyhaza, Hungary
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Tatabanya, Hungary
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Salgotarjan, Hungary
India
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Ahmedabad, India
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Kolkata, India
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Mumbai, India
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Pune, India
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Jaipur, India
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Gandhinagar, India
Ireland
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Cork, Ireland
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Cork, Ireland
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Sligo Town, Ireland
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Dublin, Ireland
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Galway, Ireland
New Zealand
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Christchurch, New Zealand
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Hamilton, New Zealand
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Auckland, New Zealand
Poland
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Olsztyn, Poland
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Bialystok, Poland
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Warszawa, Poland
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Krakow, Poland
Spain
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Alicante, Spain
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Salamanca, Spain
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Barcelona, Spain
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A Coruña, Spain
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Valencia, Spain
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Sevilla, Spain
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Alcorcón, Spain
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Madrid, Spain
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Málaga, Spain
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Badalona, Spain
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Zaragoza, Spain

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050225, CIRG/TORI 010
Study First Received:	July 24, 2006
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00356681 History of Changes
Health Authority:	Australia: Therapeutic Goods Administration; France: Agence française de sécurité sanitaire des produits de santé; Germany: Bundesinstitute für Arzneimittel und Medizinprodukte; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; India: Central Drugs Standard Control Organization; Ireland: Irish Medicines Board; New Zealand: Ministry of Health, Medicines and Medical Devices Safety Authority; Poland: Office for Medicinal Products; Spain: Agencia española del medicamento; United States: Food and Drug Administration

Keywords provided by Amgen:

Paclitaxel
Metastatic Breast Cancer
Antiangiogenic
Bevacizumab
AMG 706

Additional relevant MeSH terms:

Disease Attributes
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Breast Neoplasms
Bevacizumab
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions

Recurrence
Neoplasms
Neoplasms by Site
Pathologic Processes
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 30, 2009