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

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

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
75
sites
?
mi
from
Nashville, TN
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
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...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
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...
?
mi
from
Portland, OR
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
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...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
2001 Medical Parkway
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
3320 Old Jefferson Road
Athens, Georgia 30607
?
mi
from
Athens, GA
Click here to add this to my saved trials
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
9103 Franklin Square Drive
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
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...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Basking Ridge, New Jersey 07920
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
410 Stagecoach Road
Bristol, Virginia 24201
?
mi
from
Bristol, VA
Click here to add this to my saved trials
2600 6th Street Southwest
Canton, Ohio 44710
?
mi
from
Canton, OH
Click here to add this to my saved trials
695 South Dobson Road
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1240 Lee Street
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
650 Commack Road
Commack, New York 11725
?
mi
from
Commack, NY
Click here to add this to my saved trials
Commack, New York 11725
?
mi
from
Commack, NY
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2799 West Grand Boulevard
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
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...
?
mi
from
Durham, NC
Click here to add this to my saved trials
3840 Broadway
Fort Myers, Florida 33901
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
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...
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
7015 A C Skinner Parkway
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
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
391 Avenida San Martín
La Pampa, 6300
?
mi
from
La Pampa,
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
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...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
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...
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Marrero, Louisiana 70072
?
mi
from
Marrero, LA
Click here to add this to my saved trials
Marshfield, Wisconsin 54449
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
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...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
910 East 26th Street
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Brunswick, New Jersey 08903
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
300 East 66th Street
New York, New York 10065
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Oakland, California 94611
?
mi
from
Oakland, CA
Click here to add this to my saved trials
4200 West Memorial Road
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
300 Halket St
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
1005 Broadway Street
Quincy, Illinois 62301
?
mi
from
Quincy, IL
Click here to add this to my saved trials
1000 North Village Avenue
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
1600 Eureka Road
Roseville, California 95661
?
mi
from
Roseville, CA
Click here to add this to my saved trials
4501 X Street
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
2025 Morse Avenue
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
1201 5th Avenue North
Saint Petersburg, Florida 33719
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
1900 Electric Road
Salem, Virginia 24153
?
mi
from
Salem, VA
Click here to add this to my saved trials
10990 San Diego Mission Road
San Diego, California 92108
?
mi
from
San Diego, CA
Click here to add this to my saved trials
1-99 Garden Street
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Jose, California 94538
?
mi
from
San Jose, CA
Click here to add this to my saved trials
San Leandro, California 94577
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85258
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
777 Broadway
Sleepy Hollow, New York 10591
?
mi
from
Sleepy Hollow, NY
Click here to add this to my saved trials
1200 El Camino Real
South San Francisco, California 94080
?
mi
from
South San Francisco, CA
Click here to add this to my saved trials
Springfield, Missouri 65807
?
mi
from
Springfield, MO
Click here to add this to my saved trials
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,...
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Vallejo, California 94589
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
1425 South Main Street
Walnut Creek, California 94596
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
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...
?
mi
from
Washington,
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
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...
?
mi
from
Wichita, KS
Click here to add this to my saved trials