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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)

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 : June 28, 2021
Sponsor:
Collaborators:
NSABP Foundation Inc
German Breast Group
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1486 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 4, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




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 10 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 10 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 10 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 10 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 10 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
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

Information from the National Library of Medicine

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


Locations
Hide Hide 276 study locations
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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
Kaiser Permanente - San Diego
San Diego, California, United States, 92120
Breastlink Medical Group Inc
Santa Ana, California, United States, 92705
Stanford University Medical Center
Stanford, California, United States, 94305-5236
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
Iowa City, Iowa, United States, 52242
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
Minneapolis, Minnesota, United States, 55404
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, 96015-280
Hospital Moinhos de Vento
Porto Alegre, RS, Brazil, 90035-001
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
São Paulo, SP, Brazil, CEP 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, China, 510060
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, 80337
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
G.Sund 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, 546450
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, 29010
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; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
Aarau, Switzerland, 5001
Brustzentrum
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-Taipei
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, 34000
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
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
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
NSABP Foundation Inc
German Breast Group
Investigators
Layout table for investigator information
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: June 28, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
Layout table for 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