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:9/15/2017
Start Date:July 2015
End Date:March 2021
Contact:Sutton Edlich
Phone:(240) 552-8082

Use our guide to learn which trials are right for you!

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.

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.

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
76
sites
Anaheim, California 92801
Principal Investigator: Ajit Maniam, MD
Phone: 714-999-1465
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
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...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Hart Lowell, MD
Phone: 941-363-5713
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
1150 N 35th Ave # 330
Hollywood, Florida 33021
Principal Investigator: Alejandra Perez, MD
Phone: 954-210-1171
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Arlington, Texas 76012
Principal Investigator: Alfred DiStefano, MD
Phone: 817-261-4906
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Atlanta, Georgia 30318
Principal Investigator: Trevor Feinstein, MD
Phone: 404-350-9853
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
4359 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Martin Monte, MD
Phone: 502-210-4450
?
mi
from
Bardstown, KY
Click here to add this to my saved trials
Boston, Massachusetts 02111
Principal Investigator: John Erban, MD
Phone: 617-636-7651
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bricktown, New Jersey 08724
Principal Investigator: Apurv Agrawal, MD
Phone: 732-840-8880
?
mi
from
Bricktown, NJ
Click here to add this to my saved trials
2215 East Villa Maria Road
Bryan, Texas 77802
Principal Investigator: Erin Fleener, MD
Phone: 979-776-3984
?
mi
from
Bryan, TX
Click here to add this to my saved trials
Burbank, California 91505
Principal Investigator: Raul Mena, MD
Phone: 818-748-4723
?
mi
from
Burbank, CA
Click here to add this to my saved trials
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Robert Somer, MD
Phone: 856-735-6237
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Canton, Ohio 44718
Principal Investigator: Nashat Gabrail, MD
Phone: 330-492-3345
?
mi
from
Canton, OH
Click here to add this to my saved trials
Cedar Rapids, Iowa 52401
Principal Investigator: William Fusselman, MD
Phone: 319-368-5514
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
Chandler, Arizona 85224
Principal Investigator: Sujith Kalmadi, MD
Phone: 480-324-5230
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
Principal Investigator: Brooke Daniel, MD
Phone: 423-698-1844
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: William Gradishar, MD
Phone: 312-695-1387
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
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...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Fort Belvoir, Virginia 22060
Principal Investigator: Pramvir Verma, MD
Phone: 571-231-3491
?
mi
from
Fort Belvoir, VA
Click here to add this to my saved trials
Fort Collins, Colorado 80528
Principal Investigator: Diana Medgyesy, MD
Phone: 970-977-2979
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Fort Worth, Texas 76104
Principal Investigator: Robyn Young, MD
Phone: 817-759-7021
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Gilbert, Arizona 85234
Principal Investigator: Shakeela Bahadur, MD
Phone: 480-256-5077
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Goodyear, Arizona 85338
Principal Investigator: Cynthia Lynch, MD
Phone: 623-207-3148
?
mi
from
Goodyear, AZ
Click here to add this to my saved trials
Goshen, Indiana 46526
Principal Investigator: Daniel Bruetman, MD
Phone: 574-364-2263
?
mi
from
Goshen, IN
Click here to add this to my saved trials
600 Moye Boulevard
Greenville, North Carolina 27834
Principal Investigator: Mahvish Muzaffar, MD
Phone: 252-744-9010
?
mi
from
Greenville, NC
Click here to add this to my saved trials
4300 Londonderry Road
Harrisburg, Pennsylvania 17109
Principal Investigator: Kit Lu, MD
Phone: 717-724-6765
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
Hattiesburg, Mississippi
Principal Investigator: John Hrom, MD
Phone: 601-288-2495
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
Hazard, Kentucky 41701
Principal Investigator: Samuel Bailey, MD
Phone: 606-439-2239
?
mi
from
Hazard, KY
Click here to add this to my saved trials
Honolulu, Hawaii 96819
Principal Investigator: Jennifer Carney, MD
Phone: 808-432-4689
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Innsbruck, Tirol
Principal Investigator: Daniel Egle, MD
Phone: 43512 504 82477
?
mi
from
Innsbruck,
Click here to add this to my saved trials
Kansas City, Missouri 64111
Principal Investigator: Timothy Pluard, MD
Phone: 816-932-1601
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37920
Principal Investigator: Tracy Dobbs, MD
Phone: 865-934-2676
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lake Success, New York 11042
Principal Investigator: Marc Citron, MD
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
Principal Investigator: Peter Kaufman, MD
Phone: 603-650-6056
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Livingston, New Jersey 07039
Principal Investigator: Anna Litvak, MD
Phone: 973-322-2934
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
Long Beach, California 90801
Principal Investigator: Bichlien Nguyen, MD
Phone: 562-933-7866
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
1441 Eastlake Avenue
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
2401 Terra Crossing Boulevard
Louisville, Kentucky 40245
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Raul Oyola, MD
Phone: 770-281-5162
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Miami Beach, Florida 33140
Principal Investigator: Elisa Krill-Jackson, MD
Phone: 305-674-2121
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
Mobile, Alabama 36608
Principal Investigator: Michael Meshad, MD
Phone: 251-607-5284
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Monongahela, Pennsylvania 15063
Principal Investigator: Andrew Zahalsky, MD
Phone: 888-370-9892
?
mi
from
Monongahela, PA
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70115
Principal Investigator: Scott Sonnier, MD
Phone: 504-897-7419
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Port Richey, Florida 34655
Principal Investigator: Gail Wright, MD
Phone: 727-216-1143
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
New York, New York 10016
Principal Investigator: Yelena Novik, MD
Phone: 212-404-3918
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10065
Principal Investigator: Linda Vahdat, MD
Phone: 646-962-8342
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
Principal Investigator: Sonia Varghese, MD
Phone: 405-752-3392
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plantation, Florida
Principal Investigator: Elizabeth Tan-Chiu, MD
Phone: 954-582-1850
?
mi
from
Plantation, FL
Click here to add this to my saved trials
1871 Southeast Tiffany Avenue
Port Saint Lucie, Florida 34952
?
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
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...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63141
Principal Investigator: Bethany Sleckman, MD
Phone: 609-275-7257
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84106
Principal Investigator: Stephen Kendall, MD
Phone: 801-270-2250
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
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...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94115
Principal Investigator: Hope Rugo, MD
Phone: 415-353-7873
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Maria, California 93454
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
Sayre, Pennsylvania 18840
Principal Investigator: Philip Lowry, MD
Phone: 570-887-2141
?
mi
from
Sayre, PA
Click here to add this to my saved trials
Scarborough, Maine 04074
Principal Investigator: Chiara Battelli, MD
Phone: 207-396-8587
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Erin Ellis, MD
Phone: 206-386-2098
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98109
Principal Investigator: Lupe Salazar, MD
Phone: 206-288-7427
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Skokie, Illinois 60076
Principal Investigator: Edward Kaplan, MD
Phone: 847-675-3900
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Skokie, Illinois 60077
Principal Investigator: Ira Oliff, MD
Phone: 224-534-7580
?
mi
from
Skokie, IL
Click here to add this to my saved trials
601 South Sherman Street
Spokane, Washington 99202
Principal Investigator: Saritha Thumma, MD
Phone: 509-228-1687
?
mi
from
Spokane, WA
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Principal Investigator: Mark Pegram, MD
Phone: 650-498-7977
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tyler, Texas 75701
Principal Investigator: Robert Droder, MD
Phone: 903-596-3188
?
mi
from
Tyler, TX
Click here to add this to my saved trials
602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: Maria Grosse-Perdekamp, MD
Phone: 217-383-6828
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Vallejo, California 94589
Principal Investigator: Louis Fehrenbacher, MD
Phone: 707-651-2800
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
110 Irving Street Northwest
Washington, D.C., District of Columbia 20010
Principal Investigator: Christopher Gallagher, MD
Phone: 202-877-4775
?
mi
from
Washington, D.C.,
Click here to add this to my saved trials
West Palm Beach, Florida 33401
Principal Investigator: Sumithra Vattigunta, MD
Phone: 561-472-1696
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Principal Investigator: Susan Melin, MD
Phone: 336-716-4512
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials