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)

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT01772472
Run by: Hoffmann-La Roche
People needed: 1486
Starts: 2013-04-03
Expected to finish: 2024-05-23
Last updated by the study team: 2025-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Todd Cancer Institute at Long Beach Memorial Medical Center — Long Beach, California, United States
Chao Family Comprehensive Cancer Center — Orange, California, United States
Stanford University Medical Center — Palo Alto, California, United States
Kaiser Permanente - San Diego — San Diego, California, United States
Breastlink Medical Group Inc — Santa Ana, California, United States
Kaiser Permanente - Vallejo — Vallejo, California, United States
Kaiser Permanente - Franklin — Denver, Colorado, United States
Colorado Cancer Research Program/Admin — Denver, Colorado, United States
Yale Cancer Center — New Haven, Connecticut, United States
Washington Cancer Institute — Washington D.C., District of Columbia, United States
University of Florida — Gainesville, Florida, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
UF Health Orlando — Orlando, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Rush University Medical Center — Chicago, Illinois, United States
Edward Cancer Center Naperville — Naperville, Illinois, United States
Edward Cancer Center Plainfield — Plainfield, Illinois, United States
University of Iowa — Iowa City, Iowa, United States
University of Kentucky Medical Center — Lexington, Kentucky, United States
Norton Healthcare Inc. — Louisville, Kentucky, United States
Cancer Care of Maine — Brewer, Maine, United States
New England Cancer Specialists — Scarborough, Maine, United States
Mercy Medical Center — Baltimore, Maryland, United States
Greater Baltimore Medical Center — Baltimore, Maryland, United States
Providence Alaska Medical Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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