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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01772472
Other study ID # BO27938
Secondary ID 2012-002018-37
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 3, 2013
Est. completion date May 15, 2024

Study information

Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1487
Est. completion date May 15, 2024
Est. primary completion date July 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
trastuzumab
6 mg/kg intravenously every 3 weeks, 14 cycles
trastuzumab emtansine
3.6 mg/kg intravenously every 3 weeks, 14 cycles

Locations

Country Name City State
Argentina Fundación CENIT para la Investigación en Neurociencias Buenos Aires
Argentina Centro Oncologico Riojano Integral (CORI) La Rioja
Argentina Instituto de Oncología de Rosario Rosario
Austria Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie Innsbruck
Austria Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. Salzburg
Austria Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie Wien
Austria Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie Wien
Belgium Cliniques Universitaires St-Luc Bruxelles
Belgium AZ Sint Lucas (Sint Lucas) Gent
Belgium CHU Sart-Tilman Liège
Belgium Sint Augustinus Wilrijk Wilrijk
Brazil Hospital de Cancer de Barretos Barretos SP
Brazil Iop Instituto de Oncologia Do Parana Curitiba PR
Brazil UPCO - Unidade de Pesquisas Clínicas em Oncologia Pelotas RS
Brazil Hospital Moinhos de Vento Porto Alegre RS
Brazil Hospital Nossa Senhora da Conceicao Porto Alegre RS
Brazil Clinicas Oncologicas Integradas - COI Rio De Janeiro RJ
Brazil Instituto Nacional de Cancer - INCa; Oncologia Rio de Janeiro RJ
Brazil Hospital Perola Byington Sao Paulo SP
Brazil Hospital Sao Jose Sao Paulo SP
Brazil Instituto de Ensino e Pesquisa Sao Lucas - IEP Sao Paulo SP
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Canada Tom Baker Cancer Centre; Dept of Medicine Calgary Alberta
Canada Cross Cancer Institute ; Dept of Medical Oncology Edmonton Alberta
Canada CSSS champlain - Charles-Le Moyne Greenfield Park Quebec
Canada London Regional Cancer Centre London Ontario
Canada Centre Hospitalier de l?Université de Montréal (CHUM) Montreal Quebec
Canada Jewish General Hospital Montreal Quebec
Canada McGill University Health Centre - Glen Site Montreal Quebec
Canada The Ottawa Hospital; Division of Infectious Diseases Ottawa Ontario
Canada Hopital du Saint Sacrement Quebec City Quebec
Canada BC Cancer ? Surrey Surrey British Columbia
Canada Princess Margaret Cancer Center Toronto Ontario
Canada British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre Vancouver British Columbia
China the First Hospital of Jilin University Changchun
China Guangdong General Hospital Guangzhou
China Sun Yet-sen University Cancer Center Guangzhou City
China Harbin Medical University Cancer Hospital Harbin
China Shandong Cancer Hospital Jinan
China Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) Shanghai
China Fudan University Shanghai Cancer Center Shanghai City
Colombia Clinica del Country Bogota
Colombia Hospital Pablo Tobon Uribe Medellin
Colombia Oncomedica S.A. Monteria
Czechia Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology Hradec Kralove
Czechia Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
France Institut Sainte Catherine;Recherche Clinique Avignon
France HOPITAL JEAN MINJOZ; Oncologie Besancon
France Institut Bergonie; Oncologie Bordeaux
France Centre Hospitalier Fleyriat; Oncologie/Hematologie Bourg En Bresse
France Centre Francois Baclesse; Comite Sein Caen
France Centre Jean Perrin; Oncologie Clermont Ferrand
France Centre de Cancerologie de la Sarthe, Clinique Victor Hugo SoReCOH Le Mans
France Institut Paoli Calmettes; Oncologie Medicale Marseille
France Centre Val Aurelle Paul Lamarque; Recherche Clinique Montpellier
France Hopital Saint Louis; Oncologie Medicale Paris
France HOPITAL TENON; Cancerologie Medicale Paris
France Institut Curie; Oncologie Medicale Paris
France Centre Henri Becquerel; Oncologie Medicale Rouen
France Centre Rene Huguenin; CONSULT SPECIALISEES St Cloud
France Centre Paul Strauss; Oncologie Medicale Strasbourg
France Institut Gustave Roussy; Departement Oncologie Medicale Villejuif
Germany Hämatologie Onkologie im Zentrum MVZ GmbH Augsburg
Germany HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe Berlin
Germany Onkologische Schwerpunktpraxis Kurfürstendamm Berlin
Germany Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare) Berlin
Germany Studienzentrum Berlin City Berlin
Germany Onkologische Schwerpunktpraxis Bielefeld Bielefeld
Germany Klinikum Sindelfingen-Böblingen; Frauenklinik Böblingen
Germany St. Johannes-Hospital Dortmund
Germany Luisenkrankenhaus GmbH & Co. KG., Brustzentrum Düsseldorf
Germany Universitätsklinikum Erlangen; Frauenklinik Erlangen
Germany Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum Essen
Germany Universitätsklinikum Essen; Zentrum Für Frauenheilkunde Essen
Germany Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe Esslingen
Germany Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe Frankfurt
Germany Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Frankfurt am Main
Germany Universitätsklinikum Freiburg; Frauenklinik Freiburg
Germany Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum Gelsenkirchen
Germany Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum Greifswald
Germany Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe Halle
Germany Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie Halle
Germany Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem Hamburg
Germany St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik Hamm
Germany Diakovere Henriettenstift, Frauenklinik Hannover
Germany Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe Hannover
Germany MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer) Hannover
Germany Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg Heidelberg
Germany Elisabeth-Krankenhaus Brustzentrum Kassel
Germany Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe Kassel
Germany UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe Kiel
Germany St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe Koeln
Germany Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum Köln
Germany Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel Lebach
Germany Klinikum der Universität München; Frauenklinik - Onkologie II München
Germany Medizinisches Zentrum für Hämatologie und Onkologie München
Germany MVZ Nordhausen gGmbH, Praxis Dr. Grafe Nordhausen
Germany Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe Offenbach
Germany St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik Paderborn
Germany Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie Recklinghausen
Germany Klinikum am Steinenberg Frauenklinik Reutlingen
Germany Universitätsfrauen- und Poliklinik am Klinikum Suedstadt Rostock
Germany Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher Stralsund
Germany Robert-Bosch-Krankenhaus; Brustzentrum Stuttgart
Germany Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung Traunstein
Germany Universitätsklinik Tübingen; Frauenklinik Tübingen
Germany Universitätsklinikum Ulm Am Michelsberg; Frauenklinik Ulm
Germany HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie Wiesbaden
Germany Marien-Hospital Witten; Frauenklinik Brustzentrum Witten
Germany Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker Würzburg
Greece Univ General Hosp Heraklion; Medical Oncology Heraklion
Greece Euromedical General Clinic of Thessaloniki; Oncology Department Thessaloniki
Guatemala Centro Oncológico Sixtino / Centro Oncológico SA Guatemala
Guatemala Grupo Angeles Guatemala City
Hong Kong Pamela Youde Nethersole Eastern Hospital; Clinical Oncology Hong Kong
Hong Kong Queen Mary Hospital; Surgery Hong Kong
Hong Kong Tuen Mun Hospital; Clinical Oncology Hong Kong
Ireland Cork Uni Hospital; Oncology Dept Cork
Ireland Beaumont Hospital; Cancer Clinical Trials Unit Dublin
Ireland Mater Misericordiae Uni Hospital; Oncology Dublin
Ireland St Vincent'S Uni Hospital; Medical Oncology Dublin
Ireland Galway Uni Hospital; Oncology Dept Galway
Ireland University Hospital Limerick - Oncology Limerick
Israel Soroka Medical Center Beer Sheva
Israel Hadassah University Hospital - Ein Kerem Jerusalem
Israel Shaare Zedek Medical Center; Oncology Dept Jerusalem
Israel Rabin MC; Davidof Center - Oncology Institute Petach Tikva
Israel Sheba Medical Center; Tel Hashomer Ramat Gan
Israel Kaplan Medical Center; Oncology Inst. Rehovot
Italy Asst Papa Giovanni XXIII; Oncologia Medica Bergamo Lombardia
Italy Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica Bologna Emilia-Romagna
Italy Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii Bologna Emilia-Romagna
Italy Ospedale Antonio Perrino; Oncologia Medica Brindisi Puglia
Italy Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo Candiolo Piemonte
Italy ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit Cremona Lombardia
Italy IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A Genova Liguria
Italy Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 Milano Lombardia
Italy Irccs Ospedale San Raffaele;Oncologia Medica Milano Lombardia
Italy Istituto Europeo Di Oncologia Milano Lombardia
Italy ASST DI MONZA; Oncologia Medica Monza Lombardia
Italy Istituto Nazionale Tumori Fondazione G. Pascale Napoli Campania
Italy Università degli Studi Federico II; Clinica di Oncologia Medica Napoli Campania
Italy IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II Padova Veneto
Italy Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2 Pisa Toscana
Italy Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia Pontedera Toscana
Italy Az. Osp. Sant'Andrea; Oncologia Medica Roma Lazio
Italy Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica Roma Lazio
Italy A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O. Verona Veneto
Mexico Médicos Especialistas en Cáncer SC Aguascalientes
Mexico Hospital Angeles Metropolitano; Room 220 Mexico City Mexico CITY (federal District)
Mexico Instituto Nacional de Cancerologia; Oncology Mexico City
Mexico Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir Mexico City Mexico CITY (federal District)
Mexico Oaxaca Site Management Organization Oaxaca de Juárez Oaxaca
Panama Centro Oncologico America Panama
Panama The Panama Clinic Panama
Peru Centro Medico Monte Carmelo Arequipa
Peru Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology Arequipa
Peru Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion Bellavista
Peru Clinica San Borja Lima
Peru Hospital Nacional Guillermo Almenara Irigoyen; Oncology Lima
Serbia Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology Belgrade
Serbia Oncology Institute of Vojvodina Sremska Kamenica
South Africa Cape Town Oncology Trials Cape Town
South Africa Hopelands Cancer Centre Hilton
South Africa Medical Oncology Centre of Rosebank; Oncology Johannesburg
South Africa Wits Donald Gordon Clinical Trial Centre; Medical Oncology Johannesburg
South Africa Cancercare Port Elizabeth
South Africa Private Oncology Centre Pretoria
Spain Hospital Clínic i Provincial; Servicio de Oncología Barcelona
Spain Hospital Severo Ochoa; Servicio de Oncologia Leganes Madrid
Spain HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Madrid
Spain Hospital Universitario La Paz; Servicio de Oncologia Madrid
Spain Hospital Regional Universitario Carlos Haya; Servicio de Oncologia Malaga
Spain Hospital de Navarra; Servicio de Oncologia Navarra
Spain Hospital Universitari Sant Joan de Reus; Servicio de Oncologia Reus Tarragona
Spain Hospital Clinico Universitario de Salamanca; Servicio de Oncologia Salamanca
Spain Hospital de Donostia; Servicio de Oncologia Medica San Sebastian Guipuzcoa
Spain Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla
Spain Hospital Universitario Dr. Peset; Servicio de Oncologia Valencia
Spain Instituto Valenciano Oncologia; Oncologia Medica Valencia
Spain Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología Vigo Pontevedra
Sweden Gävle Sjukhus; Onkologiska Kliniken Gävle
Sweden Skånes University Hospital, Skånes Department of Onclology Lund
Sweden Karolinska Hospital; Oncology - Radiumhemmet Stockholm
Switzerland Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN Aarau
Switzerland Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich Zürich
Taiwan Taichung Veterans General Hospital; Dept of Surgery Taichung
Taiwan National Taiwan Uni Hospital; General Surgery Taipei
Taiwan VETERANS GENERAL HOSPITAL; Department of General Surgery Taipei
Taiwan Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology Taipei City
Taiwan Chang Gung Medical Foundation - Linkou; Dept of Surgery Taoyuan
Turkey Uludag Uni Hospital; Oncology Bursa
Turkey Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department Edirne
Turkey Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department Istanbul
Turkey Ege Uni Medical Faculty Hospital; Oncology Dept Izmir
Turkey Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department Malatya
United Kingdom University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital Birmingham
United Kingdom Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15 Bradford
United Kingdom Bristol Haematology and Oncology centre Bristol
United Kingdom Royal Cornwall Hospital; Dept of Clinical Oncology Cornwall
United Kingdom Castle Hill Hospital; The Queens Centre for Oncology and Haematology Cottingham
United Kingdom North Devon District Hospital Devon
United Kingdom Ninewells Hospital; Cancer Medicine Dundee
United Kingdom Huddersfield Royal Infirmary Huddersfield
United Kingdom Leeds Teaching Hosp NHS Trust;St James's Institute of Onc Leeds
United Kingdom Charing Cross Hospital; Medical Oncology. London
United Kingdom St Thomas Hospital; Medicine Div. London
United Kingdom Christie Hospital Nhs Trust; Medical Oncology Manchester
United Kingdom Nottingham City Hospital; Oncology Nottingham
United Kingdom Weston Park Hospital Sheffield
United States Providence Alaska Medical Center Anchorage Alaska
United States Greater Baltimore Medical Center Baltimore Maryland
United States Med Star Franklin Square Medical Center/Weinburg Cancer Institute Baltimore Maryland
United States Mercy Medical Center; Medical Oncology & Hematology Baltimore Maryland
United States Cancer Care of Maine Brewer Maine
United States Aultman Hospital; Aultman Hospital Cancer Center Canton Ohio
United States Medical University of South Carolina; Hollings Cancer Center Charleston South Carolina
United States Carolinas Medical Center Charlotte North Carolina
United States Rush University Medical Center Chicago Illinois
United States Fairview Hospital; Cleveland Clinic Cancer Center Cleveland Ohio
United States The Cleveland Clinic Foundation Cleveland Ohio
United States Ohio State University, Arthur James Cancer Hospital Columbus Ohio
United States Batte Cancer Center - Carolinas Medical Center Concord North Carolina
United States Colorado Cancer Research Program/Admin Denver Colorado
United States Kaiser Permanente - Franklin Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States Karmanos Cancer Institute Detroit Michigan
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Hematology Oncology Associates of Fredericksburg, Inc. Fredericksburg Virginia
United States University of Florida; Davis Cancer Pavilion and Shands Medical Plaza Gainesville Florida
United States Spectrum Health Hospitals Grand Rapids Michigan
United States Hartford Hospital Hartford Connecticut
United States Baylor College of Medicine Houston Texas
United States Houston Methodist Hospital Outpatient Center Houston Texas
United States Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology Houston Texas
United States Swedish Cancer Institute - Issaquah Issaquah Washington
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Breslin Cancer Center Lansing Michigan
United States University of Kentucky Medical Center Lexington Kentucky
United States Rocky Mountain Cancer Centers - Colorado Springs (Circle) Lone Tree Colorado
United States Todd Cancer Institute at Long Beach Memorial Medical Center Long Beach California
United States PeaceHealth St. John Medical Center - Lower Columbia Cancer Center Longview Washington
United States Norton Healthcare Inc. Louisville Kentucky
United States University of Iowa Lowa City Iowa
United States Joe Arrington Cancer Research & Treatment Center Lubbock Texas
United States Lynchburg Hem Onc Clinic Inc Lynchburg Virginia
United States Marshfield Clinic Marshfield Wisconsin
United States Lake Health/University Hospitals - Mentor Campus Mentor Ohio
United States Mount Sinai Medical Center Miami Beach Florida
United States Edward Cancer Center Naperville Naperville Illinois
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale Cancer Center New Haven Connecticut
United States Columbia University Medical Center New York New York
United States Chao Family Comprehensive Cancer Center; UC Irvine Medical Center Orange California
United States UF Health Orlando Orlando Florida
United States Stanford University Medical Center Palo Alto California
United States Kimmel Cancer Center Thomas Jefferson University Philadelphia Pennsylvania
United States Allegheny Cancer Center Pittsburgh Pennsylvania
United States Uni of Pittsburgh; Magee-Women'S Hospital Pittsburgh Pennsylvania
United States Edward Cancer Center Plainfield Plainfield Illinois
United States Columbia River Oncology Program Portland Oregon
United States Virginia Commonwealth University - Massey Cancer Center Richmond Virginia
United States William Beaumont Hospital Royal Oak Michigan
United States US oncology research at Minnesota Oncology Saint Paul Minnesota
United States Kaiser Permanente - San Diego San Diego California
United States Breastlink Medical Group Inc Santa Ana California
United States New England Cancer Specialists Scarborough Maine
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sparta Cancer Center Sparta New Jersey
United States Cancer Care Northwest Spokane Washington
United States Moffitt Cancer Center Tampa Florida
United States Troy Cancer Treatment Program Troy New York
United States Kaiser Permanente - Vallejo Vallejo California
United States Washington Cancer Institute; Washington Hospital Center Washington District of Columbia
United States York Hospital York Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Hoffmann-La Roche German Breast Group, NSABP Foundation Inc

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czechia,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Ireland,  Israel,  Italy,  Mexico,  Panama,  Peru,  Serbia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Invasive Disease-free Survival (IDFS) 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. From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months)
Secondary Invasive Disease-free Survival Including Second Primary Non-breast Cancer 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. From baseline up to 12 years
Secondary Disease-free Survival 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. From baseline up to 12 years
Secondary Overall Survival (OS) 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. Baseline up to 12 years
Secondary Distant Recurrence-Free Interval (DRFI) 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. Baseline up to 12 years
Secondary Percentage of Participants With Adverse Events 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). From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months)
Secondary Percentage of Participants With Cardiac Dysfunction Cardiac events were reported based on the NCI-CTCAE, v4.0. From baseline up to 12 years
Secondary 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) 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). Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12
Secondary 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) 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. Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12
Secondary Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1) Blood and serum samples for measurement of trastuzumab emtansine, total trastuzumab, and DM1 will be obtained from patients randomized to the trastuzumab emtansine arm. 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
Secondary Serum Concentrations (AUC) of Trastuzumab 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. C1D1 and C4D1 of post-infusion and study treatment termination
Secondary Plasma Concentrations of DM1 Day 1 on Cycles 1 and 4. Each cycle is 21 days.
Secondary Trastuzumab Emtansine Exposure 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.
Secondary Anti-trastuzumab Emtansine Antibody (ATA) 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.
Secondary Anti-trastuzumab Antibody (ATA) 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.
See also
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