MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/24/2016
Start Date:July 2014
Contact:Istvan Molnar, MD
Email:IMolnar@merrimack.com

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A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer

This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The
trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the
chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic
HER2-positive breast cancer patients. Patients may not have been previously treated with an
anthracycline in any setting. Patients must have received prior treatment with trastuzumab
in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the
metastatic or locally advanced setting, have either progressed or are intolerant to
pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12
months of pertuzumab treatment in the neoadjuvant or adjuvant setting.


Inclusion Criteria:

- Patients must have histologically or cytologically confirmed invasive cancer of the
breast

- Patients must have documented locally advanced/metastatic disease, defined by the
investigator, which is not amenable to resection with curative intent.

- Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines
that is confirmed by a Sponsor-designated central laboratory

- Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC
setting or had disease recurrence within 12 months of pertuzumab treatment in the
neoadjuvant or adjuvant setting.

- Patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in
the LABC/MBC setting

- Patients must have been previously treated with trastuzumab in any setting (which may
have been previously administered with or without pertuzumab)

- ECOG Performance Status of 0 or 1

Exclusion Criteria:

- Patients who have previously been treated with doxorubicin, liposomal doxorubicin,
epirubicin, mitoxantrone, or any other anthracycline derivative

- Subjects with central nervous system (CNS) metastases, unless they have been treated
and are stable without symptoms for 4 weeks after completion of treatment and must be
off steroids for at least 4 weeks prior to enrollment

- Patients with any class of New York Heart Association (NYHA) CHF or heart failure
with preserved ejection fraction (HFPEF)

- Patients with a history of known coronary artery disease or a myocardial infarction
within the last 12 months

- Patients with a known history of serious cardiac arrhythmias requiring treatment
(exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)

- Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity

- Patients with a history of LVEF decline to below 50% during or after prior
trastuzumab/lapatinib or other HER2 directed therapy.
We found this trial at
73
sites
Ann Arbor, Michigan 48197
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Albany, New York 12206
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Albuquerque, New Mexico 87109
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Aurora, Colorado 80045
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Austin, TX
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Bend, Oregon 97701
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Bend, OR
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chapel Hill, North Carolina
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Chattanooga, Tennessee 37404
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Columbus, Ohio 43210
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Coon Rapids, Minnesota 55433
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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East Setauket, New York 11733
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El Paso, Texas 79902
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Fullerton, California 92835
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Glendale, Arizona
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Greenville, South Carolina 29605
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hollywood, Florida 33021
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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11 Langer Weg
Innsbruck, 6020
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Issaquah, Washington 98029
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Jacksonville, Florida 32224
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Kansas City, Missouri 64111
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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Littleton, Colorado 80120
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Los Angeles, California 90095
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Minneapolis, Minnesota 55455
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Port Richey, Florida
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New York, New York
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New York, New York 10016
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Newnan, Georgia 30265
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Norfolk, Virginia
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Northridge, California 91325
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Plantation, Florida
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Redondo Beach, California 90277
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Salt Lake City, Utah 84112
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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San Francisco, California 94115
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Santa Barbara, California 93105
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Scottsdale, Arizona 85259
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Tacoma, Washington 98405
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Tucson, Arizona 85724
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Tyler, Texas 75702
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Vallejo, California
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Washington, District of Columbia 20010
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Zion, Illinois 60099
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