A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/9/2017
Start Date:July 31, 2010
End Date:September 16, 2016

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A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of
trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with
pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab
(Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive
progressive or recurrent locally advanced or previously untreated metastatic breast cancer.
Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be
open-label, whereas Arms B and C will be blinded.


Inclusion Criteria:

- Adult participants >/=18 years of age

- HER2-positive breast cancer

- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
recurrent or metastatic disease, and be a candidate for chemotherapy. Participants
with locally advanced disease must have recurrent or progressive disease, which must
not be amenable to resection with curative intent.

- Participants must have measurable and/or non-measurable disease which must be
evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

- Adequate organ function as determined by laboratory results

Exclusion Criteria:

- History of prior (or any) chemotherapy for metastatic breast cancer or recurrent
locally advanced disease

- An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic
chemotherapy until the time of metastatic diagnosis

- Hormone therapy <7 days prior to randomization

- Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to
randomization

- Prior trastuzumab emtansine or pertuzumab therapy
We found this trial at
92
sites
Boston, Massachusetts 02118
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Albany, New York 12206
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Albuquerque, New Mexico 87110
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2001 Medical Parkway
Annapolis, Maryland 21401
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1665 Aurora Court
Aurora, Colorado 80045
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Boise, Idaho 83712
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648 Avenida Callao
Buenos Aires, 1022
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Charleston, South Carolina 29403
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Charleston, South Carolina 29425
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1100 South Tryon Street
Charlotte, North Carolina 28203
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Chattanooga, Tennessee 37404
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5801 South Ellis Avenue
Chicago, Illinois 60637
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4350 Malsbary Road
Cincinnati, Ohio 45242
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Columbia, South Carolina 29210
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8170 Royal Palm Boulevard
Coral Springs, Florida 33065
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5323 Harry Hines Boulevard
Dallas, Texas 75390
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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407 East 3rd Street
Duluth, Minnesota 55805
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East Providence, Rhode Island 02915
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Everett, Washington 98201
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Fargo, North Dakota 58122
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Farmington, New Mexico 87401
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3840 Broadway
Fort Myers, Florida 33901
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Fresh Meadows, New York 11365
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Germantown, Tennessee 38138
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515 Michigan Street Northeast
Grand Rapids, Michigan 49503
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30 Prospect Avenue
Hackensack, New Jersey 07601
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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2406 Century Place Southeast
Hickory, North Carolina 28602
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701 Ilalo Street
Honolulu, Hawaii 96813
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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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Jacksonville, Florida 32216
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Jamaica, New York 11432
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1432 Southwest Boulevard
Jefferson City, Missouri 65109
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La Jolla, California 92037
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3855 Health Sciences Drive
La Jolla, California 92093
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Lafayette, Indiana
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Lake Success, New York 11042
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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4301 West Markham Street
Little Rock, Arkansas 72204
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Loxahatchee, Florida 33412
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1265 Union Avenue
Memphis, Tennessee 38104
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1475 Northwest 12th Avenue
Miami, Florida 33136
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3900 West Coast Highway
Montebello, California 90640
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600 North Garfield Avenue
Monterey Park, California 91754
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Nashville, Tennessee 37203
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195 Little Albany Street
New Brunswick, New Jersey 08901
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New Haven, Connecticut 06520
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
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1300 York Avenue
New York, New York 10065
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4735 Ogletown-Stanton Road
Newark, Delaware 19713
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Ogden, Utah 84403
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8303 Dodge Street
Omaha, Nebraska 68114
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Peoria, Illinois 61656
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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607 S New Ballas Rd
Saint Louis, Missouri 63141
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3800 Park Nicollet Blvd
Saint Louis Park, Minnesota 55416
(952) 993-1516
Metro-Minnesota CCOP The Metro-Minnesota Community Clinical Oncology (MMCCOP) was established in 1979 through an NCI-funded...
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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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10990 San Diego Mission Road
San Diego, California 92108
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2929 Health Center Drive
San Diego, California 92123
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Santa Ana, California 92705
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Scarborough, Maine 04074
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Sioux City, Iowa 51101
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Springfield, Missouri 65804
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Tacoma, Washington 98405
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Tucson, Arizona 85710
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
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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Walla Walla, Washington 99362
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Washington, District of Columbia 20010
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Washington, North Carolina 27889
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York, Maine 03909
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