A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:April 3, 2013
End Date:April 4, 2023

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

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab
emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer
who have residual tumor present in the breast or axillary lymph nodes following preoperative
therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6
mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or
hormone therapy will be given in addition if indicated.


Inclusion Criteria:

- Adult patient, >/= 18 years of age

- HER2-positive breast cancer

- Histologically confirmed invasive breast carcinoma

- Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be
eligible)

- Completion of preoperative systemic chemotherapy and HER2-directed treatment
consisting of at least 6 cycles of chemotherapy with a total duration of at least 16
weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based
therapy

- Adequate excision: surgical removal of all clinically evident disease in the breast
and lymph nodes as specified in protocol

- Pathological evidence of residual invasive carcinoma in the breast or axillary lymph
nodes following completion of preoperative therapy

- An interval of no more than 12 weeks between the date of surgery and the date of
randomization

- Known hormone-receptor status

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematologic, renal and liver function

- Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO)
or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no
decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or,
if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after
completion of neoadjuvant chemotherapy.

- For women who are not postmenopausal or surgically sterile: agreement to remain
abstinent or use single or combined contraceptive methods that result in a failure
rate of < 1% per year during the treatment period and for at least 7 months after the
last dose of study drug

- Documentation of hepatitis B virus and hepatitis C virus serology is required

Exclusion Criteria:

- Stage IV (metastatic) breast cancer

- History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in
situ

- Evidence of clinically evident gross residual or recurrent disease following
preoperative therapy and surgery

- Progressive disease during preoperative systemic therapy

- Treatment with any anti-cancer investigational drug within 28 days prior to commencing
study treatment

- History of other malignancy within the last 5 years except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer,
or other non-breast malignancies with a similar outcome to those mentioned above

- Patients for whom radiotherapy would be recommended for breast cancer treatment but
for whom it is contraindicated because of medical reasons

- Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy

- History of exposure to the following cumulative doses of anthracyclines: Doxorubicin >
240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2;
For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2

- Cardiopulmonary dysfunction as defined by protocol

- Prior treatment with trastuzumab emtansine

- Current severe, uncontrolled systemic disease

- Pregnant or lactating women

- Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or
sclerosing cholangitis

- Concurrent serious uncontrolled infections requiring treatment or known infection with
HIV

- History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity
to trastuzumab or murine proteins or any components of the product
We found this trial at
92
sites
Denver, Colorado 80205
?
mi
from
Denver, CO
Click here to add this to my saved trials
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
740 South Limestone Street
Lexington, Kentucky 40536
?
mi
from
Lexington, KY
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
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
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, Georgia 31701
?
mi
from
Albany, GA
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
361 Old Belgrade Road
Augusta, Maine 04330
?
mi
from
Augusta, ME
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
9000 Franklin Square Drive
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Brewer, Maine 04412
?
mi
from
Brewer, ME
Click here to add this to my saved trials
353 Avenida Callao
Buenos Aires, C1022
?
mi
from
Buenos Aires,
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
?
mi
from
Charleston, SC
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
18200 Lorain Avenue
Cleveland, Ohio 44111
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
410 West 10th Avenue
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
100 Medical Park Drive Northeast
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
1720 South Bellaire Street
Denver, Colorado 80222
?
mi
from
Denver, CO
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
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
231 East Brown Street
East Stroudsburg, Pennsylvania 18301
?
mi
from
East Stroudsburg, PA
Click here to add this to my saved trials
Ephrata, Pennsylvania 17522
?
mi
from
Ephrata, PA
Click here to add this to my saved trials
Fargo, North Dakota 58122
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Fredericksburg, VA
Click here to add this to my saved trials
2000 Southwest Archer Road
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
102 Park Street
Glens Falls, New York 12801
?
mi
from
Glens Falls, NY
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Issaquah, Washington 98029
?
mi
from
Issaquah, WA
Click here to add this to my saved trials
1235 San Marco Boulevard
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Joplin, Missouri 64804
?
mi
from
Joplin, MO
Click here to add this to my saved trials
12040 Northeast 128th Street
Kirkland, Washington 98034
?
mi
from
Kirkland, WA
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
Lansing, Michigan 48910
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Las Vegas, Nevada 89106
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
10103 RidgeGate Parkway
Lone Tree, Colorado 80124
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Long Branch, New Jersey
?
mi
from
Long Branch, NJ
Click here to add this to my saved trials
1615 Delaware Street
Longview, Washington 98632
?
mi
from
Longview, WA
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
1701 Thomson Drive
Lynchburg, Virginia 24501
?
mi
from
Lynchburg, VA
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
6780 Mayfield Rd
Mayfield Heights, Ohio 44124
?
mi
from
Mayfield Heights, OH
Click here to add this to my saved trials
9485 Mentor Avenue
Mentor, Ohio 44060
?
mi
from
Mentor, OH
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
2900 West Oklahoma Avenue
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
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
Monroe, North Carolina 28112
?
mi
from
Monroe, NC
Click here to add this to my saved trials
Mount Vernon, Washington 98274
?
mi
from
Mount Vernon, WA
Click here to add this to my saved trials
120 Spalding Drive
Naperville, Illinois 60540
?
mi
from
Naperville, IL
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
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
?
mi
from
New Haven, CT
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
201 Lyons Avenue
Newark, New Jersey 07112
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
721 North Shiawassee Street
Owosso, Michigan 48867
?
mi
from
Owosso, MI
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
300 Halket Street
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plainfield, Illinois 60585
?
mi
from
Plainfield, IL
Click here to add this to my saved trials
Portland, Oregon 97225
?
mi
from
Portland, OR
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
San Diego, California 92120
?
mi
from
San Diego, 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
Scarborough, Maine 04074
?
mi
from
Scarborough, ME
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
417 West Warren Street
Shelby, North Carolina 28150
?
mi
from
Shelby, NC
Click here to add this to my saved trials
1309 West 17th Street
Sioux Falls, South Dakota 57104
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Sparta, New Jersey 07871
?
mi
from
Sparta, NJ
Click here to add this to my saved trials
Spokane, Washington 99218
?
mi
from
Spokane, WA
Click here to add this to my saved trials
1235 East Cherokee Street
Springfield, Missouri 65804
?
mi
from
Springfield, MO
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
?
mi
from
Traverse City, MI
Click here to add this to my saved trials
Troy, New York 12180
?
mi
from
Troy, NY
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
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
Wheat Ridge, Colorado 80033
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
York, Pennsylvania 17315
?
mi
from
York, PA
Click here to add this to my saved trials