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)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: trastuzumab Drug: trastuzumab emtansine | Phase 3 |
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 |

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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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).
- 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.
- 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.
- 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.
- Plasma Concentrations of DM1 [ Time Frame: Day 1 on Cycles 1 and 4. Each cycle is 21 days. ]
- 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. ]
- 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. ]
- 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. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772472

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 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Documents provided by Hoffmann-La Roche:
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01772472 |
Other Study ID Numbers: |
BO27938 2012-002018-37 ( EudraCT Number ) |
First Posted: | January 21, 2013 Key Record Dates |
Results First Posted: | October 1, 2019 |
Last Update Posted: | January 10, 2023 |
Last Verified: | December 2022 |
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 |