A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:January 31, 2014
End Date:January 31, 2024

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A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety
of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination
with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth
(HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and
anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a
dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg)
intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at
a dose of 420 mg IV q3w in combination with a taxane.


Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(
- Non-metastatic histologically confirmed primary invasive breast carcinoma that was
operable

- HER2-positive breast cancer

- Known hormone receptor status of the primary tumor

- Adequately excised: participants must have undergone either breast-conserving surgery
or mastectomy/nipple- or skin-sparing mastectomy

- Pathological tumor-node-metastasis staging (Union for International Cancer
Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible
participants must have either:

Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any
hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0
centimeters by standard local assessment and negative for estrogen receptor (ER) and
progesterone receptor (PR) determined by a central pathology laboratory

- Participants with synchronous bilateral invasive disease are eligible only if both
lesions are HER2-positive

- No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the
last surgery if additional resection required for breast cancer) and randomization

- Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram
(ECHO; preferred) or multiple-gated acquisition (MUGA) scans

- Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is
required

- Female participants of childbearing potential must be willing to use one highly
effective form of non-hormonal contraception or two effective forms of non-hormonal
contraception. For male participants with partners of childbearing potential, one
highly effective form of contraception or two effective forms of contraception must be
used. Contraception must continue for the duration of study treatment and for 6 months
after the last dose of study treatment

Exclusion Criteria:

- History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma

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

- Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC
7th edition, including inflammatory breast cancer

- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment
(for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy,
anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab,
lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR
anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the
time of primary surgery is acceptable)

- Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any
malignancy

- History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic
chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer
subsequently developed. Participants who had their DCIS/LCIS treated with surgery only
and/or contralateral DCIS treated with radiation are allowed to enter the study

- Participants with contraindication to RT while adjuvant RT is clinically indicated

- Concurrent anti-cancer treatment in another investigational trial

- Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring
anti-anginal medication, serious cardiac arrhythmia not controlled by adequate
medication, severe conduction abnormality, or clinically significant valvular disease,
significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac
arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to
randomization, uncontrolled hypertension, evidence of transmural infarction on
electrocardiogram (ECG), requirement for oxygen therapy

- Other concurrent serious diseases that may interfere with planned treatment, including
severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes,
or known infection with HIV

- Any known active liver disease. For participants who are known carriers of HBV/HCV,
active hepatitis B/C infection must be ruled out per local guidelines

- Inadequate hematologic, renal or liver function

- Pregnant or lactating women

- Hypersensitivity to any of the study medications or any of the ingredients or
excipients of these medications, including hypersensitivity to benzyl alcohol

- Chronic immunosuppressive therapies, including systemic corticosteroids
We found this trial at
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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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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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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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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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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2001 Medical Parkway
Annapolis, Maryland 21401
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3320 Old Jefferson Road
Athens, Georgia 30607
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Atlanta, Georgia 30341
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9103 Franklin Square Drive
Baltimore, Maryland 21237
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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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Boston, Massachusetts 02115
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410 Stagecoach Road
Bristol, Virginia 24201
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2600 6th Street Southwest
Canton, Ohio 44710
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695 South Dobson Road
Chandler, Arizona 85224
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Charlotte, North Carolina 28211
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1240 Lee Street
Charlottesville, Virginia 22908
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Chattanooga, Tennessee 37404
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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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650 Commack Road
Commack, New York 11725
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Commack, New York 11725
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Detroit, Michigan 48201
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2799 West Grand Boulevard
Detroit, Michigan 48202
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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3840 Broadway
Fort Myers, Florida 33901
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Germantown, Tennessee 38138
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501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
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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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391 Avenida San Martín
La Pampa, 6300
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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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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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Macon, Georgia 31201
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Marrero, Louisiana 70072
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2160 South 1st Avenue
Maywood, Illinois 60153
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Miami Beach, Florida 33140
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910 East 26th Street
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New Brunswick, New Jersey 08903
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300 East 66th Street
New York, New York 10065
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oakland, California 94611
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4200 West Memorial Road
Oklahoma City, Oklahoma 73120
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300 Halket St
Pittsburgh, Pennsylvania 15213
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1005 Broadway Street
Quincy, Illinois 62301
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1000 North Village Avenue
Rockville Centre, New York 11570
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1600 Eureka Road
Roseville, California 95661
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4501 X Street
Sacramento, California 95817
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2025 Morse Avenue
Sacramento, California 95825
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1201 5th Avenue North
Saint Petersburg, Florida 33719
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1900 Electric Road
Salem, Virginia 24153
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10990 San Diego Mission Road
San Diego, California 92108
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1-99 Garden Street
San Francisco, California 94115
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San Jose, California 94538
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Scottsdale, Arizona 85258
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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777 Broadway
Sleepy Hollow, New York 10591
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1200 El Camino Real
South San Francisco, California 94080
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Springfield, Missouri 65807
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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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1425 South Main Street
Walnut Creek, California 94596
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Washington, District of Columbia 20010
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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