Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer



Status:Completed
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:November 2013
End Date:August 7, 2018

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A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study)

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.

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.

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible for
the study:

1. 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

2. Documented progression of disease based on radiographic, clinical or pathologic
assessment during or subsequent to the last anticancer regimen received.

3. 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.

4. Received no more than two prior chemotherapy treatments for advanced (locally
advanced/recurrent or metastatic) breast cancer.

5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or
Doxil) if clinically indicated and a taxane (eg: Taxol).

6. ECOG performance status of 0 - 1.

7. 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:

1. Progression/recurrence of breast cancer during or within 3 months of completion of
neoadjuvant or adjuvant chemotherapy.

2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are
moderate (Grade 2) or worse in severity.

3. Known brain metastases, unless previously treated and asymptomatic for 2 months and
not progressive in size or number for 2 months.

4. Significant cardiovascular disease.

5. Previously received capecitabine and discontinued due to progression or intolerance;
previously received CDX-011 or other MMAE containing agents.

6. Active systemic infection requiring treatment. Infection controlled by oral therapy
will not be exclusionary.

7. Chronic use of systemic corticosteroids.
We found this trial at
73
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Anneliese Gonzalez, MD
Phone: 832-325-7710
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Baltimore, Maryland 21231
410-955-6190
Principal Investigator: Antonio Wolff, MD
Phone: 410-955-8804
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Andres Forero, MD
Phone: 205-934-4317
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Rita Nanda, MD
Phone: 773-834-1758
University of Chicago One of the world's premier academic and research institutions, the University of...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Julie Nangia, MD
Phone: 713-798-7315
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Isaam Makhoul, MD
Phone: 501-686-8274
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Jennifer Specht, MD
Phone: 206-288-1363
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Annapolis, Maryland 21401
Principal Investigator: David Weng, MD
Phone: 443-481-4393
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Keerthi Gogineni, MD
Phone: 404-778-4824
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, Georgia 30341
Principal Investigator: Gena Volas-Redd, MD
Phone: 478-745-6130
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Atlanta, Georgia 30318
Principal Investigator: Trevor Feinstein, MD
Phone: 678-298-3241
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Katherine Tkaczuk, MD
Phone: 410-328-3546
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Beaverton, Oregon 97006
Principal Investigator: Jacqueline Vuky, MD
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Birmingham, Alabama 35223
Principal Investigator: Katisha Vance, MD
Phone: 205-803-4369
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Charleston, South Carolina 29414
Principal Investigator: David Ellison, MD
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Charlotte, North Carolina 28210
Principal Investigator: Ayla Kessler, MD
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Chattanooga, Tennessee 37404
Principal Investigator: Brooke Daniel, MD
Phone: 423-698-1844
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: Patrick Ward, MD
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cleveland, Ohio 44195
Principal Investigator: Alberto Montero, MD
Phone: 216-444-9649
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Darlinghurst, New South Wales 2010
Principal Investigator: Elgene Lim, MD
Phone: 61293555614
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Deerfield Beach, Florida 33442
Principal Investigator: Charles Vogel, MD
Phone: 954-698-3673
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Kimberly Blackwell, MD
Phone: 919-660-1278
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Flemington, New Jersey 08822
Principal Investigator: Myron Bednar, MD
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Fort Myers, Florida 33916
Principal Investigator: Lowell Hart, MD
Phone: 615-524-4007
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800 West Magnolia Avenue
Fort Worth, Texas 76104
Principal Investigator: Robyn Young, MD
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Fountain Valley, California 92708
Principal Investigator: Haresh Jhangiani, MD
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Frederick, Maryland 21701
Principal Investigator: Brian O'Connor, MD
Phone: 301-662-8477
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Fullerton, California 92835
Principal Investigator: William Lawler, MD
Phone: 714-992-3000
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Glendale, Arizona 85304
Principal Investigator: Manpreet Chadha, MD
Phone: 480-945-6896
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Deena Graham, MD
Phone: 551-996-8258
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Harvey, Illinois 60426
Principal Investigator: Alexandar Starr, MD
Phone: 708-915-6119
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Hollywood, Florida 33021
Principal Investigator: Marcelo Blaya, MD
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Houston, Texas 77030
Principal Investigator: Angel Rodriguez
Phone: 713-441-6011
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Phone: 904-202-7319
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2316 East Meyer Boulevard
Kansas City, Missouri 64132
Principal Investigator: Stephanie Graff, MD
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Knoxville, Tennessee 37909
Principal Investigator: Tracey Dobbs, MD
Phone: 865-934-2675
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Lafayette, Louisiana 70503
Principal Investigator: Molly Thomas, MD
Phone: 337-289-8556
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Lake Success, New York 11042
Principal Investigator: Francis Arena, MD
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Lake Success, New York 11042
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Lake Success, New York 11042
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Langhorne, Pennsylvania 19047
Principal Investigator: Robert Reilly, MD
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Los Angeles, California 90089
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Lubbock, Texas 79430
Principal Investigator: Zeina Nahleh, MD
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Marietta, Georgia 30060
Principal Investigator: Raul Oyola, MD
Phone: 770-281-5131
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Marrero, Louisiana 70072
Principal Investigator: Milton Seiler, MD
Phone: 504-885-8220
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Middletown, Ohio 45042
Principal Investigator: Nandagopal Vrindavanam, MD
Phone: 513-423-0504
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Minneapolis, Minnesota 55407
Principal Investigator: Michaela Tsai, MD
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Mobile, Alabama 36604
Principal Investigator: Carole Norden, MD
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: Denise Yardley, MD
Phone: 615-524-4240
Sarah Cannon Cancer Center People who live with cancer
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New York, New York 10065
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Oklahoma City, Oklahoma 73120
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Principal Investigator: Madhuri Bajaj, MD
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Philadelphia, Pennsylvania 19111
Principal Investigator: Elias Obeid, MD
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Helen Chew, MD
Phone: 916-734-8266
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Cynthia Ma, MD
Phone: 314-362-0263
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621 South New Ballas Road
Saint Louis, Missouri 63141
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Salinas, California 93901
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Principal Investigator: Michelle Melisko, MD
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Savannah, Georgia 31405
Principal Investigator: Mark Taylor, MD
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Sayre, Pennsylvania 18840
Principal Investigator: Cynthia Lynch, MD
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Seattle, Washington 98104
Principal Investigator: Erin Ellis, MD
Phone: 206-215-3086
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Silver Spring, Maryland 20910
Principal Investigator: Cheryl Aylesworth, MD
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Skokie, Illinois 60076
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Principal Investigator: Alison Stopeck, MD
Phone: 631-638-0836
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Tallahassee, Florida 32308
Principal Investigator: Karen Russell
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Tucson, Arizona
Principal Investigator: Pavani Chalasani, MD
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: Kendrith Rowland, MD
Phone: 217-383-6828
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Vallejo, California 94589
Principal Investigator: Louis Fehrenbacher, MD
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West Hills, California 91307
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