Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:August 24, 2015
End Date:March 2021
Contact:Sutton Edlich
Phone:(240) 552-8082

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A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

The purpose of this study is to determine whether patients treated with margetuximab plus
chemotherapy have longer progression free survival and overall survival than patients treated
with trastuzumab plus chemotherapy.

An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by
independent review and overall survival (OS), of margetuximab plus chemotherapy compared with
trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received
at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of
having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy
in the metastatic setting, and who have received at least one, and no more than three, lines
of therapy overall in the metastatic setting. A non-randomized sub-study cohort of
approximately 78 patients will be enrolled to evaluate the safety of a reduced margetuximab
infusion rate in patients receiving margetuximab either as monotherapy or in combination with
chemotherapy.

Inclusion Criteria:

- Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast
cancer based on the most recently available tumor biopsy collected from the patient.
Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.

- Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic
setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line
of anti-HER2 directed therapy in the metastatic setting. In either case, patients must
have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic
setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are
allowed.

- Prior treatment with at least one, and no more than three, lines of therapy overall in
the metastatic setting. Patients must have progressed on or following, the most recent
line of therapy.

- Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1

- Life expectancy ≥ 12 weeks

- Acceptable laboratory parameters

- Women of childbearing potential must have negative pregnancy test performed within 14
days of randomization and on the first day of treatment. All subjects must agree to
use an effective form of contraception for the duration of study treatment and for 7
months after the last dose of study drug.

Infusion sub-study prior therapy requirements: Same as above, except:

- Must have received 4 or more prior lines or therapy in the metastatic setting

- Must have received prior trastuzumab, pertuzumab, and T-DM1

Exclusion Criteria:

- Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis
must have a CT or MRI performed within 4 weeks prior to randomization to specifically
exclude the presence of radiographically-detected brain metastases

- History of uncontrolled seizures within 6 months of randomization

- History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation

- History of clinically significant cardiovascular disease

- Clinically-significant pulmonary compromise, including a requirement for supplemental
oxygen use to maintain adequate oxygenation

- Any condition that would be a contraindication to receiving trastuzumab as described
in the approved local label or a condition that would prevent treatment with the
physician's choice of chemotherapy
We found this trial at
90
sites
Austin, Texas 78303
Principal Investigator: Angel Rodriguez, MD
Phone: 512-505-5500
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Christiana Brenin, MD
Phone: 434-297-7782
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Hart Lowell, MD
Phone: 941-363-5713
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1150 N 35th Ave # 330
Hollywood, Florida 33021
Principal Investigator: Alejandra Perez, MD
Phone: 954-210-1171
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Albuquerque, New Mexico 87106
Principal Investigator: Ursa Brown-Glaberman, MD
Phone: 505-925-0354
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Anaheim, California 92801
Principal Investigator: Ajit Maniam, MD
Phone: 714-999-1465
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Annapolis, Maryland 21401
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Arlington, Texas 76012
Principal Investigator: Alfred DiStefano, MD
Phone: 817-261-4906
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Atlanta, Georgia 30318
Principal Investigator: Trevor Feinstein, MD
Phone: 404-350-9853
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: David Riseberg, MD
Phone: 410-951-7956
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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4359 New Shepherdsville Road
Bardstown, Kentucky 40004
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Boston, Massachusetts 02111
Principal Investigator: John Erban, MD
Phone: 617-636-7651
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Brick, New Jersey 08724
Principal Investigator: Apurv Agrawal, MD
Phone: 732-840-8880
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2215 East Villa Maria Road
Bryan, Texas 77802
Principal Investigator: Erin Fleener, MD
Phone: 979-776-3984
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Burbank, California 91505
Principal Investigator: Raul Mena, MD
Phone: 818-748-4723
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
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Cedar Rapids, Iowa 52401
Principal Investigator: William Fusselman, MD
Phone: 319-368-5514
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Chandler, Arizona 85224
Principal Investigator: Sujith Kalmadi, MD
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Chattanooga, Tennessee 37404
Principal Investigator: Brooke Daniel, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Melody Cobleigh, MD
Phone: 312-942-5083
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: William Gradishar, MD
Phone: 312-695-1387
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Barbara Haley, MD
Phone: 214-648-7020
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Fairfax, Virginia 22031
Principal Investigator: Mary Wilkinson, MD
Phone: 571-472-0239
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Fort Belvoir, Virginia 22060
Principal Investigator: Pramvir Verma, MD
Phone: 571-231-3491
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Fort Collins, Colorado 80528
Principal Investigator: Diana Medgyesy, MD
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Fort Worth, Texas 76104
Principal Investigator: Robyn Young, MD
Phone: 817-759-7021
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Frederick, Maryland 21701
Principal Investigator: Brian O'Connor, MD
Phone: 301-668-7043
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Gilbert, Arizona 85234
Principal Investigator: Shakeela Bahadur, MD
Phone: 480-256-5077
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Goodyear, Arizona 85338
Principal Investigator: Cynthia Lynch, MD
Phone: 623-207-3148
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Goshen, Indiana 46526
Principal Investigator: Daniel Bruetman, MD
Phone: 574-364-2263
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600 Moye Boulevard
Greenville, North Carolina 27834
Principal Investigator: Mahvish Muzaffar, MD
Phone: 252-744-9010
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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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4300 Londonderry Road
Harrisburg, Pennsylvania 17109
Principal Investigator: Kit Lu, MD
Phone: 717-724-6765
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Hattiesburg, Mississippi
Principal Investigator: John Hrom, MD
Phone: 601-288-2495
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Hazard, Kentucky 41701
Principal Investigator: Samuel Bailey, MD
Phone: 606-439-2239
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Honolulu, Hawaii 96819
Principal Investigator: Jennifer Carney, MD
Phone: 808-432-4689
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Innsbruck, Tirol
Principal Investigator: Daniel Egle, MD
Phone: 43512 504 82477
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Jamaica, New York 11432
Principal Investigator: Mary Kemeny, MD
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Kansas City, Missouri 64111
Principal Investigator: Timothy Pluard, MD
Phone: 816-932-1601
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Knoxville, Tennessee 37920
Principal Investigator: Tracy Dobbs, MD
Phone: 865-934-2676
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1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
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Lake Success, New York 11042
Principal Investigator: Marc Citron, MD
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Lebanon, New Hampshire 03756
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Lexington, Kentucky 40504
Principal Investigator: Jessica Croley, MD
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Livingston, New Jersey 07039
Principal Investigator: Anna Litvak, MD
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Long Beach, California 90801
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100 Medical Plaza Driveway
Los Angeles, California 90095
Principal Investigator: Sara Hurvitz, MD
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1441 Eastlake Avenue
Los Angeles, California 90033
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2401 Terra Crossing Boulevard
Louisville, Kentucky 40245
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Marietta, Georgia 30060
Principal Investigator: Raul Oyola, MD
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Miami Beach, Florida 33140
Principal Investigator: Elisa Krill-Jackson, MD
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Minneapolis, Minnesota 55408
Principal Investigator: Michaela Tsai, MD
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Mobile, Alabama 36608
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Monongahela, Pennsylvania 15063
Principal Investigator: Andrew Zahalsky, MD
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Denise Yardley, MD
Phone: 615-524-4447
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Orleans, Louisiana 70115
Principal Investigator: Scott Sonnier, MD
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New Port Richey, Florida 34655
Principal Investigator: Gail Wright, MD
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New York, New York 10016
Principal Investigator: Yelena Novik, MD
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New York, New York 10065
Principal Investigator: Eleni Andreopoulou, MD
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600 Celebrate Life Pkwy
Newnan, Georgia 30265
Principal Investigator: Mary Ninan, MD
Phone: 770-440-7191
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Oklahoma City, Oklahoma 73112
Principal Investigator: Sonia Varghese, MD
Phone: 405-752-3392
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Orlando, Florida 32806
Principal Investigator: Nikita Shah, MD
Phone: 321-843-8370
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Philadelphia, Pennsylvania 19124
Principal Investigator: Sramila Aithal, MD
Phone: 215-537-4881
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Plantation, Florida
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1871 Southeast Tiffany Avenue
Port Saint Lucie, Florida 34952
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4501 X St
Sacramento, California 95817
(916) 734-5800
Principal Investigator: Helen Chew, MD
Phone: 916-703-5559
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Saint Louis, Missouri 63141
Principal Investigator: Bethany Sleckman, MD
Phone: 609-275-7257
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Salt Lake City, Utah 84106
Principal Investigator: Stephen Kendall, MD
Phone: 801-270-2250
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7901 Frost Street
San Diego, California 92123
858-939-3400
Principal Investigator: Reema Batra, MD
Phone: 858-939-5063
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Francisco, California 94115
Principal Investigator: Hope Rugo, MD
Phone: 415-353-7873
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Santa Maria, California 93454
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Sayre, Pennsylvania 18840
Principal Investigator: Philip Lowry, MD
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Scarborough, Maine 04074
Principal Investigator: Chiara Battelli, MD
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Seattle, Washington 98104
Principal Investigator: Erin Ellis, MD
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Seattle, Washington 98109
Principal Investigator: Lupe Salazar, MD
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Skokie, Illinois 60076
Principal Investigator: Edward Kaplan, MD
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Skokie, Illinois 60077
Principal Investigator: Ira Oliff, MD
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601 South Sherman Street
Spokane, Washington 99202
Principal Investigator: Saritha Thumma, MD
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Tulsa, Oklahoma 74133
Principal Investigator: Sagun Shrestha, MD
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Tyler, Texas 75701
Principal Investigator: Arielle Lee, MD
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: Maria Grosse-Perdekamp, MD
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Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Vallejo, California 94589
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Washington, District of Columbia
Principal Investigator: Christopher Gallagher, MD
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West Palm Beach, Florida 33401
Principal Investigator: Sumithra Vattigunta, MD
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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Zion, Illinois 60099
Principal Investigator: Dennis Citrin, MD
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