A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:November 8, 2011
End Date:December 1, 2023

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A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and
efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in
participants with operable HER2-positive primary breast cancer. This study will be carried
out in collaboration with the Breast International Group (BIG).


Inclusion Criteria:

- Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is
histologically confirmed, and adequately excised

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(
- Known hormone receptor status (estrogen receptor and progesterone receptor)

- The interval between definitive surgery for breast cancer and the first dose of
chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy
must be administered within 7 days of randomization or on Day 56, whichever occurs
first

- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55
percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA)
Scan

- Confirmed HER2 positive status

- Completion of all necessary baseline laboratory and radiologic investigations prior to
randomization

- Women of childbearing potential and male participants with partners of childbearing
potential must agree to use effective contraception (as defined by the protocol) by
the participant and/or partner for the duration of the study treatment and for at
least 7 months after the last dose of study drug

Exclusion Criteria:

- History of any prior (ipsi- and/or contralateral) invasive breast cancer

- History of non-breast malignancies within the 5 years prior to study entry, except for
carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and
basal cell and squamous cell carcinomas of the skin

- Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant
metastasis (TNM), including inflammatory breast cancer

- Any node-negative tumor

- Any previous systemic chemotherapy for cancer or radiotherapy for cancer

- Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy
for cancer

- Concurrent anti-cancer treatment in another investigational trial

- Serious cardiac or cardiovascular disease or condition

- Other concurrent serious diseases that may interfere with planned treatment including
severe pulmonary conditions/illness

- Abnormal laboratory tests immediately prior to randomization

- Pregnant or lactating women

- Sensitivity to any of the study medications or any of the ingredients or excipients of
these medications
We found this trial at
144
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Sioux City, Iowa 51101
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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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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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3700 Johnson Street
Hollywood, Florida 33021
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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3525
Lakeland, Florida 33805
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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433 Southwest 10th Street
Ocala, Florida 34471
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Akron, Ohio 44304
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Albany, Georgia 31701
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Albany, New York 12206
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Atlanta, Georgia 30341
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9103 Franklin Square Drive
Baltimore, Maryland 21237
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Basking Ridge, New Jersey 07920
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6420 Rockledge Drive
Bethesda, Maryland 20817
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90 Poly Drive
Billings, Montana 59101
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Boston, Massachusetts 02118
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330 Brookline Avenue
Boston, Massachusetts 02215
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450 Brookline Avenue
Boston, Massachusetts 02215
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Brewer, Maine 04412
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410 Stagecoach Road
Bristol, Virginia 24201
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Buenos Aires,
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Buffalo, New York 14263
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Charleston, South Carolina
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Charleston, South Carolina 29403
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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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5801 South Ellis Avenue
Chicago, Illinois 60637
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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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1 Hospital Drive
Columbia, Missouri 65203
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Columbia, South Carolina 29210
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
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Commack, New York 11725
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dayton, Ohio 45429
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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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4700 East Hale Parkway
Denver, Colorado 80220
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Edina, Minnesota 55432
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1700 13th Street
Everett, California 98208
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Fargo, North Dakota 58122
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3840 Broadway
Fort Myers, Florida 33901
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Fort Worth, Texas 76104
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Garland, Texas
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25 Michigan St. NE, Suite 3100
Grand Rapids, Michigan 49503
(616) 391-1230
Grand Rapids Clinical Oncology Program GRCOP initially formed to develop community cancer patient management guidelines....
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Green Bay, Wisconsin 54303
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Green Bay, Wisconsin 54301
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Greenbrae, California 94904
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65 International Drive
Greenville, South Carolina 29615
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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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Hayward, California 94545
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2406 Century Place Southeast
Hickory, North Carolina 28602
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1 Baylor Plaza
Hoston, Texas 77096
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925 Gessner Road
Houston, Texas 77024
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1504 Ben Taub Loop
Houston, Texas 77030
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Irving, Texas 75063
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2021 North MacArthur Boulevard
Irving, Texas 75063
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Jackson, Mississippi 39202
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Jacksonville, Florida 32216
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
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Jonesboro, Arkansas 72401
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6420 Rockledge Drive
Kensington, Maryland 20895
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4485 West Stone Drive
Kingsport, Tennessee 37660
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La Jolla, California 92093
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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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Lincoln, Nebraska 68510
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Manchester, New Hampshire 03104
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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Marshfield, Wisconsin 54449
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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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910 East 26th Street
Minneapolis, Minnesota 55404
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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120 Spalding Drive
Naperville, Illinois 60540
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Nashville, Tennessee 37203
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1448 Common Street
New Braunfels, Texas 78130
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10003
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New York, New York 10025
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330 Washington Street
Norwich, Connecticut 06360
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Oakland, California 94611
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Omaha, Nebraska 68106
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2751 Bay Park Drive
Oregon, Ohio 43616
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603 North Flamingo Road
Pembroke Pines, Florida 33028
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Peoria, Illinois 61656
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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