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)

• ClinicalTrials.gov Identifier: NCT01772472
• Recruitment Status: Active, not recruiting
• First Posted: January 21, 2013
• Results First Posted: October 1, 2019
• Last Update Posted: January 10, 2023
• Sponsor: Hoffmann-La Roche
• Collaborators: NSABP Foundation Inc; German Breast Group
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: trastuzumab; Drug: trastuzumab emtansine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1487 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 3, 2013
• Actual Primary Completion Date: July 25, 2018
• Estimated Study Completion Date: April 3, 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Trastuzumab	Drug: trastuzumab; 6 mg/kg intravenously every 3 weeks, 14 cycles
Experimental: Trastuzumab emtansine	Drug: trastuzumab emtansine; 3.6 mg/kg intravenously every 3 weeks, 14 cycles

Outcome Measures

Primary Outcome Measures :

1. Invasive Disease-free Survival (IDFS) [ Time Frame: From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months) ]
   IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.

Secondary Outcome Measures :

1. Invasive Disease-free Survival Including Second Primary Non-breast Cancer [ Time Frame: From baseline up to 12 years ]
   IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). 3-year IDFS including second primary non-breast cancer event-free rates per treatment arm in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
2. Disease-free Survival [ Time Frame: From baseline up to 12 years ]
   Disease-free survival was defined as the time between randomization and the date of the first occurrence of an invasive disease-free survival event including second primary non-breast cancer event or contralateral or ipsilateral DCIS. 3-year DFS event-free rates per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
3. Overall Survival (OS) [ Time Frame: Baseline up to 12 years ]
   Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. 5 years OS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 5 years after treatment.
4. Distant Recurrence-Free Interval (DRFI) [ Time Frame: Baseline up to 12 years ]
   DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3 years DRFI event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.
5. Percentage of Participants With Adverse Events [ Time Frame: From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months) ]
   An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
6. Percentage of Participants With Cardiac Dysfunction [ Time Frame: From baseline up to 12 years ]
   Cardiac events were reported based on the NCI-CTCAE, v4.0.
7. Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) [ Time Frame: Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12 ]
   The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
8. Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23) [ Time Frame: Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12 ]
   EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in quality of life (QOL) and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in quality of life (QOL) and negative change from baseline indicated a deterioration in QOL.
9. Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1) [ Time Frame: Cycle (C) 1, Day (D) 1 and C4D1 of pre-infusion, C1D1 and C4D1 post-infusion, C2D1 and C5D1 pre-infusion and study treatment termination ]
   Blood and serum samples for measurement of trastuzumab emtansine, total trastuzumab, and DM1 will be obtained from patients randomized to the trastuzumab emtansine arm.
10. Serum Concentrations (AUC) of Trastuzumab [ Time Frame: C1D1 and C4D1 of post-infusion and study treatment termination ]
    Serum blood samples were collected for trastuzumab measurement prior to dosing and 15-30 minutes post infusion for Cycle 1 and Cycle 4. Additional serum samples were collected at study treatment termination.
11. Plasma Concentrations of DM1 [ Time Frame: Day 1 on Cycles 1 and 4. Each cycle is 21 days. ]
12. Trastuzumab Emtansine Exposure [ Time Frame: Day 1 on Cycles 1, 2, 4 and 5, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days. ]
13. Anti-trastuzumab Emtansine Antibody (ATA) [ Time Frame: Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days. ]
14. Anti-trastuzumab Antibody (ATA) [ Time Frame: Day 1 on Cycles 1, and 4, at study treatment termination and 3-4 months after last dose of trastuzumab emtansine. Each cycle is 21 days. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alaska

Providence Alaska Medical Center

Anchorage, Alaska, United States, 99508

United States, California

Todd Cancer Institute at Long Beach Memorial Medical Center

Long Beach, California, United States, 90806

Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

Orange, California, United States, 92868

Stanford University Medical Center

Palo Alto, California, United States, 94304

Kaiser Permanente - San Diego

San Diego, California, United States, 92120

Breastlink Medical Group Inc

Santa Ana, California, United States, 92705

Kaiser Permanente - Vallejo

Vallejo, California, United States, 94589

United States, Colorado

Kaiser Permanente - Franklin

Denver, Colorado, United States, 80205

Colorado Cancer Research Program/Admin

Denver, Colorado, United States, 80222

Rocky Mountain Cancer Centers - Colorado Springs (Circle)

Lone Tree, Colorado, United States, 80124

United States, Connecticut

Hartford Hospital

Hartford, Connecticut, United States, 06102

Yale Cancer Center

New Haven, Connecticut, United States, 06520

United States, District of Columbia

Washington Cancer Institute; Washington Hospital Center

Washington, District of Columbia, United States, 20010

United States, Florida

University of Florida; Davis Cancer Pavilion and Shands Medical Plaza

Gainesville, Florida, United States, 32610

Mount Sinai Medical Center

Miami Beach, Florida, United States, 33140

UF Health Orlando

Orlando, Florida, United States, 32806

Moffitt Cancer Center

Tampa, Florida, United States, 33612

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

Edward Cancer Center Naperville

Naperville, Illinois, United States, 60540

Edward Cancer Center Plainfield

Plainfield, Illinois, United States, 60585

United States, Iowa

University of Iowa

Lowa City, Iowa, United States, 52242-1086

United States, Kentucky

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

Norton Healthcare Inc.

Louisville, Kentucky, United States, 40202

United States, Maine

Cancer Care of Maine

Brewer, Maine, United States, 04412

New England Cancer Specialists

Scarborough, Maine, United States, 04074

United States, Maryland

Mercy Medical Center; Medical Oncology & Hematology

Baltimore, Maryland, United States, 21202

Greater Baltimore Medical Center

Baltimore, Maryland, United States, 21204

Med Star Franklin Square Medical Center/Weinburg Cancer Institute

Baltimore, Maryland, United States, 21237

United States, Michigan

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Henry Ford Health System

Detroit, Michigan, United States, 48202

Spectrum Health Hospitals

Grand Rapids, Michigan, United States, 49503

Breslin Cancer Center

Lansing, Michigan, United States, 48910

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

United States, Minnesota

US oncology research at Minnesota Oncology

Saint Paul, Minnesota, United States, 55102

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901

Sparta Cancer Center

Sparta, New Jersey, United States, 07871-1791

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

Troy Cancer Treatment Program

Troy, New York, United States, 12180

United States, North Carolina

Carolinas Medical Center

Charlotte, North Carolina, United States, 28204-2839

Batte Cancer Center - Carolinas Medical Center

Concord, North Carolina, United States, 28025

United States, North Dakota

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58102

United States, Ohio

Aultman Hospital; Aultman Hospital Cancer Center

Canton, Ohio, United States, 44710

Fairview Hospital; Cleveland Clinic Cancer Center

Cleveland, Ohio, United States, 44111

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Ohio State University, Arthur James Cancer Hospital

Columbus, Ohio, United States, 43210

Lake Health/University Hospitals - Mentor Campus

Mentor, Ohio, United States, 44060

United States, Oregon

Columbia River Oncology Program

Portland, Oregon, United States, 97213

United States, Pennsylvania

Kimmel Cancer Center Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States, 15212

Uni of Pittsburgh; Magee-Women'S Hospital

Pittsburgh, Pennsylvania, United States, 15213

York Hospital

York, Pennsylvania, United States, 17403

United States, South Carolina

Medical University of South Carolina; Hollings Cancer Center

Charleston, South Carolina, United States, 29425

United States, South Dakota

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

United States, Tennessee

Thompson Cancer Survival Center

Knoxville, Tennessee, United States, 37916-2305

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

Houston Methodist Hospital Outpatient Center

Houston, Texas, United States, 77030

Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology

Houston, Texas, United States, 77030

Joe Arrington Cancer Research & Treatment Center

Lubbock, Texas, United States, 79410

United States, Virginia

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States, 22408

Lynchburg Hem Onc Clinic Inc

Lynchburg, Virginia, United States, 24501

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, United States, 23298

United States, Washington

Swedish Cancer Institute - Issaquah

Issaquah, Washington, United States, 98029

PeaceHealth St. John Medical Center - Lower Columbia Cancer Center

Longview, Washington, United States, 98632

Cancer Care Northwest

Spokane, Washington, United States, 99204

United States, Wisconsin

Marshfield Clinic

Marshfield, Wisconsin, United States, 54449

Argentina

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina, C1125ABD

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina, F5300COE

Instituto de Oncología de Rosario

Rosario, Argentina, S2000KZE

Austria

Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

Innsbruck, Austria, 6020

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

Salzburg, Austria, 5020

Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

Wien, Austria, 1090

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

Wien, Austria, 1090

Belgium

Cliniques Universitaires St-Luc

Bruxelles, Belgium, 1200

AZ Sint Lucas (Sint Lucas)

Gent, Belgium, 9000

CHU Sart-Tilman

Liège, Belgium, 4000

Sint Augustinus Wilrijk

Wilrijk, Belgium, 2610

Brazil

Iop Instituto de Oncologia Do Parana

Curitiba, PR, Brazil, 80530-010

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, RJ, Brazil, 20560-120

Clinicas Oncologicas Integradas - COI

Rio De Janeiro, RJ, Brazil, 22290-160

UPCO - Unidade de Pesquisas Clínicas em Oncologia

Pelotas, RS, Brazil, 96020-080

Hospital Moinhos de Vento

Porto Alegre, RS, Brazil, 90035-000

Hospital Nossa Senhora da Conceicao

Porto Alegre, RS, Brazil, 91350-200

Hospital de Cancer de Barretos

Barretos, SP, Brazil, 14784-400

Instituto de Ensino e Pesquisa Sao Lucas - IEP

Sao Paulo, SP, Brazil, 01236-030

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, SP, Brazil, 01246-000

Hospital Perola Byington

Sao Paulo, SP, Brazil, 01317-000

Hospital Sao Jose

Sao Paulo, SP, Brazil, 01321-001

Canada, Alberta

Tom Baker Cancer Centre; Dept of Medicine

Calgary, Alberta, Canada, T2N 4N2

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, Canada, T6G 1Z2

Canada, British Columbia

BC Cancer - Surrey

Surrey, British Columbia, Canada, V3V 1Z2

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

London Regional Cancer Centre

London, Ontario, Canada, N6A 4L6

The Ottawa Hospital; Division of Infectious Diseases

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Center

Toronto, Ontario, Canada, M5G 1Z5

Canada, Quebec

CSSS champlain - Charles-Le Moyne

Greenfield Park, Quebec, Canada, J4V 2H1

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada, H2X 0C2

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada, H4A 3J1

Hopital du Saint Sacrement

Quebec City, Quebec, Canada, G1S 4L8

China

the First Hospital of Jilin University

Changchun, China, 130021

Sun Yet-sen University Cancer Center

Guangzhou City, China, 510663

Guangdong General Hospital

Guangzhou, China, 510080

Harbin Medical University Cancer Hospital

Harbin, China, 150081

Shandong Cancer Hospital

Jinan, China, 250117

Fudan University Shanghai Cancer Center

Shanghai City, China, 200120

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

Shanghai, China, 200025

Colombia

Clinica del Country

Bogota, Colombia, 11001

Hospital Pablo Tobon Uribe

Medellin, Colombia, 050034

Oncomedica S.A.

Monteria, Colombia, 230002

Czechia

Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

Hradec Kralove, Czechia, 500 05

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, Czechia, 779 00

Vseobecna fakultni nemocnice v Praze

Praha 2, Czechia, 128 08

France

Institut Sainte Catherine;Recherche Clinique

Avignon, France, 84918

HOPITAL JEAN MINJOZ; Oncologie

Besancon, France, 25030

Institut Bergonie; Oncologie

Bordeaux, France, 33076

Centre Hospitalier Fleyriat; Oncologie/Hematologie

Bourg En Bresse, France, 01012

Centre Francois Baclesse; Comite Sein

Caen, France, 14076

Centre Jean Perrin; Oncologie

Clermont Ferrand, France, 63011

Clinique Victor Hugo; Chimiotherapie

Le Mans, France, 72015

Institut Paoli Calmettes; Oncologie Medicale

Marseille, France, 13273

Centre Val Aurelle Paul Lamarque; Recherche Clinique

Montpellier, France, 34298

Institut Curie; Oncologie Medicale

Paris, France, 75231

Hopital Saint Louis; Oncologie Medicale

Paris, France, 75475

HOPITAL TENON; Cancerologie Medicale

Paris, France, 75970

Centre Henri Becquerel; Oncologie Medicale

Rouen, France, 76038

Centre Rene Huguenin; CONSULT SPECIALISEES

St Cloud, France, 92210

Centre Paul Strauss; Oncologie Medicale

Strasbourg, France, 67065

Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, France, 94805

Germany

Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

Augsburg, Germany, 86150

Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

Berlin, Germany, 10367

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, Germany, 10707

HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

Berlin, Germany, 13125

Studienzentrum Berlin City

Berlin, Germany, 14169

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, Germany, 33604

Klinikum Sindelfingen-Böblingen; Frauenklinik

Böblingen, Germany, 71032

St. Johannes-Hospital

Dortmund, Germany, 44137

Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

Düsseldorf, Germany, 40235

Universitätsklinikum Erlangen; Frauenklinik

Erlangen, Germany, 91054

Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

Essen, Germany, 45122

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

Essen, Germany, 45136

Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

Esslingen, Germany, 73730

Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

Frankfurt am Main, Germany, 60389

Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

Frankfurt, Germany, 60596

Universitätsklinikum Freiburg; Frauenklinik

Freiburg, Germany, 79106

Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

Gelsenkirchen, Germany, 45879

Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

Greifswald, Germany, 17475

Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

Halle, Germany, 06110

Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

Halle, Germany, 06120

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

Hamburg, Germany, 20357

St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik

Hamm, Germany, 59073

Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

Hannover, Germany, 30177

Diakovere Henriettenstift, Frauenklinik

Hannover, Germany, 30559

Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

Hannover, Germany, 30625

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

Heidelberg, Germany, 69120

Elisabeth-Krankenhaus Brustzentrum

Kassel, Germany, 34117

Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

Kassel, Germany, 34125

UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

Kiel, Germany, 24105

St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

Koeln, Germany, 50935

Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

Köln, Germany, 51067

Gemeinschaftspraxis für Hämatologie und Onkologie PD Dr. Bauer, Dr. Kremers

Lebach, Germany, 66822

Klinikum der Universität München; Frauenklinik - Onkologie II

München, Germany, 80336

Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

München, Germany, 80638

MVZ Nordhausen gGmbH, Praxis Dr. Grafe

Nordhausen, Germany, 99734

Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

Offenbach, Germany, 63069

St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik

Paderborn, Germany, 33098

Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

Recklinghausen, Germany, 45659

Klinikum am Steinenberg Frauenklinik

Reutlingen, Germany, 72764

Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

Rostock, Germany, 18059

Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

Stralsund, Germany, 18439

Robert-Bosch-Krankenhaus; Brustzentrum

Stuttgart, Germany, 70376

Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung

Traunstein, Germany, 83278

Universitätsklinik Tübingen; Frauenklinik

Tübingen, Germany, 72076

Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

Ulm, Germany, 89075

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

Wiesbaden, Germany, 65199

Marien-Hospital Witten; Frauenklinik Brustzentrum

Witten, Germany, 58452

Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

Würzburg, Germany, 97080

Greece

Univ General Hosp Heraklion; Medical Oncology

Heraklion, Greece, 711 10

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, Greece, 546 45

Guatemala

Grupo Angeles

Guatemala City, Guatemala, 01015

Centro Oncológico Sixtino / Centro Oncológico SA

Guatemala, Guatemala, 01010

Hong Kong

Queen Mary Hospital; Surgery

Hong Kong, Hong Kong, 852

Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

Hong Kong, Hong Kong

Tuen Mun Hospital; Clinical Oncology

Hong Kong, Hong Kong

Ireland

Cork Uni Hospital; Oncology Dept

Cork, Ireland

St Vincent'S Uni Hospital; Medical Oncology

Dublin, Ireland, 4

Mater Misericordiae Uni Hospital; Oncology

Dublin, Ireland, 7

Beaumont Hospital; Cancer Clinical Trials Unit

Dublin, Ireland, 9

Galway Uni Hospital; Oncology Dept

Galway, Ireland

University Hospital Limerick - Oncology

Limerick, Ireland

Israel

Soroka Medical Center

Beer Sheva, Israel, 8410101

Shaare Zedek Medical Center; Oncology Dept

Jerusalem, Israel, 9103102

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel, 9112001

Rabin MC; Davidof Center - Oncology Institute

Petach Tikva, Israel, 4941492

Sheba Medical Center; Tel Hashomer

Ramat Gan, Israel, 5262100

Kaplan Medical Center; Oncology Inst.

Rehovot, Israel, 7610001

Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Campania, Italy, 80131

Università degli Studi Federico II; Clinica di Oncologia Medica

Napoli, Campania, Italy, 80131

Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

Bologna, Emilia-Romagna, Italy, 40138

Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

Bologna, Emilia-Romagna, Italy, 40139

Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

Roma, Lazio, Italy, 00128

Az. Osp. Sant'Andrea; Oncologia Medica

Roma, Lazio, Italy, 00189

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genova, Liguria, Italy, 16132

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardia, Italy, 24127

ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

Cremona, Lombardia, Italy, 26100

Irccs Ospedale San Raffaele;Oncologia Medica

Milano, Lombardia, Italy, 20132

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

Milano, Lombardia, Italy, 20133

Istituto Europeo Di Oncologia

Milano, Lombardia, Italy, 20141

ASST DI MONZA; Oncologia Medica

Monza, Lombardia, Italy, 20900

Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

Candiolo, Piemonte, Italy, 10060

Ospedale Antonio Perrino; Oncologia Medica

Brindisi, Puglia, Italy, 72100

Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

Pisa, Toscana, Italy, 56100

Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

Pontedera, Toscana, Italy, 56025

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

Padova, Veneto, Italy, 35128

A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

Verona, Veneto, Italy, 37126

Mexico

Hospital Angeles Metropolitano; Room 220

Mexico City, Mexico CITY (federal District), Mexico, 06760

Centenario Hospital Miguel Hidalgo

Aguascalientes, Mexico, 20230

Instituto Nacional de Cancerologia; Oncology

Distrito Federal, Mexico, 14080

Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir

Mexico City, Mexico, 14080

Oaxaca Site Management Organization

Oaxaca, Mexico, 68000

Panama

Centro Hemato Oncologico Panama

Panama, Panama, 0832

Centro Oncologico America

Panama, Panama, 0834-02723

Peru

Centro Medico Monte Carmelo

Arequipa, Peru, 04001

Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

Arequipa, Peru, 04001

Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

Bellavista, Peru, Callao 2

Hospital Nacional Guillermo Almenara Irigoyen; Oncology

Lima, Peru, 13

Clinica San Borja

Lima, Peru, Lima 41

Serbia

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, Serbia, 11000

Oncology Institute of Vojvodina

Sremska Kamenica, Serbia, 21204

South Africa

Cape Town Oncology Trials

Cape Town, South Africa, 7570

Hopelands Cancer Centre

Hilton, South Africa, 3245

Medical Oncology Centre of Rosebank; Oncology

Johannesburg, South Africa, 2196

Wits Donald Gordon Clinical Trial Centre; Medical Oncology

Parktown, Johannesburg, South Africa, 2193

Cancercare

Port Elizabeth, South Africa, 6045

Private Oncology Centre

Pretoria, South Africa, 0081

Spain

Hospital de Donostia; Servicio de Oncologia Medica

San Sebastian, Guipuzcoa, Spain, 20080

Hospital Severo Ochoa; Servicio de Oncologia

Leganes, Madrid, Spain, 28911

Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

Vigo, Pontevedra, Spain, 36312

Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

Reus, Tarragona, Spain, 43204

Hospital Clínic i Provincial; Servicio de Oncología

Barcelona, Spain, 08036

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, Spain, 28046

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, Spain, 28050

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

Malaga, Spain, 29011

Hospital de Navarra; Servicio de Oncologia

Navarra, Spain, 31008

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

Salamanca, Spain, 37007

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla, Spain, 41013

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, Spain, 46009

Hospital Universitario Dr. Peset; Servicio de Oncologia

Valencia, Spain, 46017

Sweden

Gävle Sjukhus; Onkologiska Kliniken

Gävle, Sweden, 80187

Skånes University Hospital, Skånes Department of Onclology

Lund, Sweden, 221 85

Karolinska Hospital; Oncology - Radiumhemmet

Stockholm, Sweden, 171 76

Switzerland

Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN

Aarau, Switzerland, 5001

Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

Zürich, Switzerland, 8008

Taiwan

Taichung Veterans General Hospital; Dept of Surgery

Taichung, Taiwan, 407

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

Taipei City, Taiwan, 11259

VETERANS GENERAL HOSPITAL; Department of General Surgery

Taipei, Taiwan, 00112

National Taiwan Uni Hospital; General Surgery

Taipei, Taiwan, 100

Chang Gung Medical Foundation - Linkou; Dept of Surgery

Taoyuan, Taiwan, 333

Turkey

Uludag Uni Hospital; Oncology

Bursa, Turkey, 16059

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, Turkey, 22770

Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

Istanbul, Turkey, 34865

Ege Uni Medical Faculty Hospital; Oncology Dept

Izmir, Turkey, 35100

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, Turkey, 44280

United Kingdom

University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15

Bradford, United Kingdom, BD9 6RJ

Bristol Haematology and Oncology Centre

Bristol, United Kingdom, BS2 8ED

Royal Cornwall Hospital; Dept of Clinical Oncology

Cornwall, United Kingdom, TR1 3LQ

Castle Hill Hospital; The Queens Centre for Oncology and Haematology

Cottingham, United Kingdom, HU16 5JG

North Devon District Hospital

Devon, United Kingdom, EX31 4JB

Ninewells Hospital; Cancer Medicine

Dundee, United Kingdom, DD1 9SY

Huddersfield Royal Infirmary

Huddersfield, United Kingdom, HD3 3EA

Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

Leeds, United Kingdom, LS9 7TF

St Thomas Hospital; Medicine Div.

London, United Kingdom, SE1 7EH

Charing Cross Hospital; Medical Oncology.

London, United Kingdom, W6 8RF

Christie Hospital Nhs Trust; Medical Oncology

Manchester, United Kingdom, M2O 4BX

Nottingham City Hospital; Oncology

Nottingham, United Kingdom, NG5 1PB

Weston Park Hospital

Sheffield, United Kingdom, S10 2SJ

Sponsors and Collaborators

Hoffmann-La Roche

NSABP Foundation Inc

German Breast Group

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] October 13, 2015

Statistical Analysis Plan  [PDF] November 5, 2012

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01772472
• Other Study ID Numbers: BO27938; 2012-002018-37 ( EudraCT Number )
• First Posted: January 21, 2013
• Results First Posted: October 1, 2019
• Last Update Posted: January 10, 2023
• Last Verified: December 2022

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasm, Residual; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Neoplastic Processes; Pathologic Processes; Trastuzumab; Ado-Trastuzumab Emtansine; Maytansine; Antineoplastic Agents, Immunological; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action