Breast Cancer Clinical Trial
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
Summary
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
Full Description
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (gpNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death.
This study will examine the efficacy and safety of CDX-011 in patients with advanced TNBC that makes the gpNMB protein. The effect of CDX-011 will be compared to treatment with capecitabine.
Eligible patients who enroll in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.
Eligibility Criteria
Inclusion Criteria:
Among other criteria, patients must meet all of the following conditions to be eligible for the study:
Diagnosed with metastatic (i.e., cancer that has spread) TNBC
minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry
HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell
Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
ECOG performance status of 0 - 1.
Adequate bone marrow, liver and renal function.
Exclusion:
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
Significant cardiovascular disease.
Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
Chronic use of systemic corticosteroids.
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There are 136 Locations for this study
Birmingham Alabama, 35211, United States
Birmingham Alabama, 35294, United States
Mobile Alabama, 36604, United States
Glendale Arizona, 85304, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Fountain Valley California, 92708, United States
Fullerton California, 92835, United States
Los Angeles California, 90033, United States
Sacramento California, 95817, United States
Salinas California, 93901, United States
San Francisco California, 94115, United States
Vallejo California, 94589, United States
West Hills California, 91307, United States
Deerfield Beach Florida, 33442, United States
Fort Myers Florida, 33916, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32207, United States
New Port Richey Florida, 34655, United States
Tallahassee Florida, 32308, United States
Atlanta Georgia, 30318, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30341, United States
Marietta Georgia, 30060, United States
Savannah Georgia, 31405, United States
Chicago Illinois, 60637, United States
Harvey Illinois, 60426, United States
Peoria Illinois, 60615, United States
Skokie Illinois, 60077, United States
Urbana Illinois, 61801, United States
Lafayette Louisiana, 70503, United States
Marrero Louisiana, 70072, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Frederick Maryland, 21701, United States
Silver Spring Maryland, 20902, United States
Minneapolis Minnesota, 55407, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Flemington New Jersey, 08822, United States
Hackensack New Jersey, 07601, United States
Lake Success New York, 11042, United States
Lake Success New York, 11042, United States
New York New York, 10011, United States
New York New York, 10021, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44195, United States
Middletown Ohio, 45042, United States
Oklahoma City Oklahoma, 73120, United States
Beaverton Oregon, 97006, United States
Langhorne Pennsylvania, 19047, United States
Philadelphia Pennsylvania, 19111, United States
Sayre Pennsylvania, 18840, United States
Charleston South Carolina, 29414, United States
Chattanooga Tennessee, 37404, United States
Knoxville Tennessee, 37909, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Lubbock Texas, 79430, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Darlinghurst New South Wales, 2010, Australia
Macquarie Park New South Wales, 2109, Australia
Tweed Heads New South Wales, 2485, Australia
Wahroonga New South Wales, 2076, Australia
Douglas Queensland, 4814, Australia
Box Hill Victoria, 3128, Australia
Footscray Victoria, 3011, Australia
Heidelberg Victoria, 3084, Australia
Richmond Victoria, 3121, Australia
Wilrijk Antwerpen, 2610, Belgium
Charleroi Hainaut, 6000, Belgium
Leuven Vlaams Brabant, 3000, Belgium
Brussels Capital Region , 1180, Belgium
Bruxelles , 1000, Belgium
Sault Ste Marie Ontario, P6B-0, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5B 1, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4J 1, Canada
Nice Alpes-Maritimes, 06189, France
Lyon Rhône, 69373, France
Le Mans Sarthe, 72000, France
Avignon , 84000, France
Lille , 59000, France
Lyon , 69317, France
Mont de Marsan , 40000, France
Paris , 75005, France
Pierre Benite , 69495, France
St Gregoire , 35768, France
Esslingen Am Neckar Baden-Wurttemberg, 73730, Germany
Berlin , 13125, Germany
Cologne , 51067, Germany
Düsseldorf , 40225, Germany
Erlangen , 91054, Germany
Frankfurt am Main , 65929, Germany
Halle , 06120, Germany
Homberg , 66421, Germany
Munich , 80637, Germany
Münster , 48149, Germany
Troisdorf , 53840, Germany
Meldola Emilia-Romagna, 47014, Italy
Roma Lazio, 00168, Italy
Milano Lombardia, 20121, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Rozzano Lombardia, 20089, Italy
Aviano Pordenone, 33081, Italy
Pisa Toscana, 56126, Italy
Bologna , 40138, Italy
Torino , 10126, Italy
Oviedo Asturias, 33011, Spain
Badalona Barcelona, 08916, Spain
Sabadell Barcelona, 08208, Spain
Castellon de La Plana Castellón, 12002, Spain
Madrid Communidad Delaware, 28034, Spain
Malaga Málaga, 29011, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28033, Spain
Madrid , , Spain
Valencia , 46010, Spain
London City Of London, EC1A , United Kingdom
Plymouth Devon, PL6 8, United Kingdom
Brighton East Sussex, BN2 5, United Kingdom
Glasgow Glasgow City, G12 0, United Kingdom
Blackpool Lancashire, FY3 8, United Kingdom
London London, City Of, NW1 2, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
City of London , W1G 6, United Kingdom
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