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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Hoffmann-La Roche
Sponsor:
Collaborators:
German Breast Group
NSABP Foundation Inc
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01772472
First received: January 17, 2013
Last updated: February 1, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Breast Cancer
Drug: trastuzumab
Drug: trastuzumab emtansine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Invasive disease-free survival (IDFS): Time from randomization to ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death of any cause [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Invasive disease-free survival including second non-breast cancers [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Disease-free survival: Time from randomization to first occurrence of an IDFS event including second primary non-breast cancer or contralateral or ipsilateral ductal carcinoma in situ [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Overall survival: Time from randomization to death of any cause [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Distant recurrence-free interval: Time from randomization to date of distant breast cancer recurrence [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Incidence of cardiac events: Death from cardiac cause or severe chronic heart failure (NYHA Class III or IV) [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • Patient reported outcomes: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Quetionnaire QLQ-C30/QLQ-BR23, EuroQol EQ-5d Questionnaire [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1484
Study Start Date: April 2013
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 treatment consisting of at least 6 cycles 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
  • Left ventricular ejection fraction (LVEF) >/= 50% at screening and no decrease in LVEF by more than 15% absolute points from pre-chemotherapy
  • Women of childbearing potential and men with partners of childbearing potential must be willing to use effective contraception as defined by protocol for the duration of study treatment and for at least 6 months after the last dose of study treatment
  • 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 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 > 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 or known infection with HIV
  • History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772472

Contacts
Contact: Reference Study ID Number: BO27938 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alaska
Recruiting
Anchorage, Alaska, United States, 99508
United States, California
Active, not recruiting
Long Beach, California, United States, 90806
Active, not recruiting
Orange, California, United States, 92868
Active, not recruiting
San Diego, California, United States, 92120
Active, not recruiting
Santa Ana, California, United States, 92705
Active, not recruiting
Stanford, California, United States, 94305-5236
Active, not recruiting
Vallejo, California, United States, 94589
United States, Colorado
Recruiting
Denver, Colorado, United States, 80205
Active, not recruiting
Denver, Colorado, United States, 80222
Recruiting
Lone Tree, Colorado, United States, 80124
Terminated
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Recruiting
Hartford, Connecticut, United States, 06102
Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Recruiting
Gainesville, Florida, United States, 32610
Terminated
Jacksonville, Florida, United States, 32207
Recruiting
Miami Beach, Florida, United States, 33140
Active, not recruiting
Orlando, Florida, United States, 32806
Active, not recruiting
Tampa, Florida, United States, 33612-9497
United States, Georgia
Terminated
Albany, Georgia, United States, 31701
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60612
Active, not recruiting
Naperville, Illinois, United States, 60540
Active, not recruiting
Plainfield, Illinois, United States, 60585
United States, Iowa
Active, not recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Active, not recruiting
Lexington, Kentucky, United States, 40536
Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Maine
Terminated
Augusta, Maine, United States, 04330
Recruiting
Brewer, Maine, United States, 04412
Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Terminated
Baltimore, Maryland, United States, 21218
Active, not recruiting
Baltimore, Maryland, United States, 21204
Active, not recruiting
Baltimore, Maryland, United States, 21202
Active, not recruiting
Baltimore, Maryland, United States, 21237
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
Recruiting
Detroit, Michigan, United States, 48202
Recruiting
Grand Rapids, Michigan, United States, 49503
Recruiting
Lansing, Michigan, United States, 48910
Active, not recruiting
Owosso, Michigan, United States, 48867
Recruiting
Royal Oak, Michigan, United States, 48073
Active, not recruiting
Traverse City, Michigan, United States, 49614
United States, Minnesota
Active, not recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Terminated
Joplin, Missouri, United States, 64804
Terminated
Springfield, Missouri, United States, 65804
United States, Nevada
Terminated
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Terminated
Long Branch, New Jersey, United States, 07740
Recruiting
New Brunswick, New Jersey, United States, 08901
Terminated
Newark, New Jersey, United States, 07112
Recruiting
Sparta, New Jersey, United States, 07871-1791
United States, New York
Terminated
Glenn Falls, New York, United States, 12801
Recruiting
New York, New York, United States, 10032
Terminated
Stony Brook, New York, United States, 11794
Recruiting
Troy, New York, United States, 12180
United States, North Carolina
Active, not recruiting
Charlotte, North Carolina, United States, 28204-2839
Active, not recruiting
Concord, North Carolina, United States, 28025
Terminated
Monroe, North Carolina, United States, 28211
Terminated
Shelby, North Carolina, United States, 28150
United States, North Dakota
Active, not recruiting
Fargo, North Dakota, United States, 58122-9988
United States, Ohio
Terminated
Akron, Ohio, United States, 44304
Active, not recruiting
Canton, Ohio, United States, 44710
Terminated
Cleveland, Ohio, United States, 44106-5067
Active, not recruiting
Cleveland, Ohio, United States, 44111
Active, not recruiting
Cleveland, Ohio, United States, 44195
Active, not recruiting
Columbus, Ohio, United States, 43210
Terminated
Mayfield Heights, Ohio, United States, 44124
Completed
Mentor, Ohio, United States, 44060
United States, Oregon
Recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Terminated
East Stroudsburg, Pennsylvania, United States, 18301
Terminated
Ephrata, Pennsylvania, United States, 17543
Recruiting
Philadelphia, Pennsylvania, United States, 19107
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15212
Recruiting
York, Pennsylvania, United States, 17403
United States, South Carolina
Active, not recruiting
Charleston, South Carolina, United States, 29425
United States, South Dakota
Terminated
Sioux Falls, South Dakota, United States, 57104
Active, not recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Active, not recruiting
Knoxville, Tennessee, United States, 37916-2305
United States, Texas
Recruiting
Houston, Texas, United States, 77030
Active, not recruiting
Houston, Texas, United States, 77030
Recruiting
Lubbock, Texas, United States, 79410
United States, Virginia
Active, not recruiting
Fredericksburg, Virginia, United States, 22408
Active, not recruiting
Lynchburg, Virginia, United States, 24501
Active, not recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Recruiting
Issaquah, Washington, United States, 98029
Terminated
Kirkland, Washington, United States, 98034
Recruiting
Longview, Washington, United States, 98632
Terminated
Mount Vernon, Washington, United States, 98273
Terminated
Seattle, Washington, United States, 98101
Recruiting
Spokane, Washington, United States, 99204
United States, Wisconsin
Active, not recruiting
Marshfield, Wisconsin, United States, 54449
Terminated
Milwaukee, Wisconsin, United States, 53215
Argentina
Active, not recruiting
Caba, Argentina, C1025ABI
Terminated
Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
Active, not recruiting
La Rioja, Argentina, F5300COE
Active, not recruiting
Rosario, Argentina, S2000KZE
Austria
Active, not recruiting
Innsbruck, Austria, 6020
Active, not recruiting
Salzburg, Austria, 5020
Active, not recruiting
Wien, Austria, 1090
Belgium
Active, not recruiting
Bruxelles, Belgium, 1200
Active, not recruiting
Gent, Belgium, 9000
Active, not recruiting
Liège, Belgium, 4000
Recruiting
Wilrijk, Belgium, 2610
Brazil
Active, not recruiting
Curitiba, PR, Brazil, 80530-010
Active, not recruiting
Rio De Janeiro, RJ, Brazil, 22290-160
Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Active, not recruiting
Porto Alegre, RS, Brazil, 90035-001
Active, not recruiting
Porto Alegre, RS, Brazil, 90540-140
Recruiting
Porto Alegre, RS, Brazil, 91350-200
Active, not recruiting
Barretos, SP, Brazil, 14784-400
Active, not recruiting
Jau, SP, Brazil, 17210-080
Terminated
Sao Jose dos Campos, SP, Brazil, 12245-750
Active, not recruiting
Sao Paulo, SP, Brazil, 01246-000
Active, not recruiting
Sao Paulo, SP, Brazil, 01236-030
Active, not recruiting
Sao Paulo, SP, Brazil, 01317-000
Terminated
Sao Paulo, SP, Brazil, 01321-000
Active, not recruiting
São Paulo, SP, Brazil, CEP 01321-001
Canada, Alberta
Active, not recruiting
Calgary, Alberta, Canada, T2N 4N2
Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Active, not recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Active, not recruiting
London, Ontario, Canada, N6A 4L6
Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Active, not recruiting
Montreal, Quebec, Canada, H2X 0A9
Active, not recruiting
Montreal, Quebec, Canada, H3G 1A4
Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
Canada
Active, not recruiting
Quebec, Canada, G1S 4L8
China
Active, not recruiting
Changchun, China, 130021
Active, not recruiting
Guangzhou, China
Active, not recruiting
Guangzhou, China, 510060
Active, not recruiting
Harbin, China, 150081
Active, not recruiting
Jinan, China, 250117
Active, not recruiting
Nanjing, China, 210036
Active, not recruiting
Shanghai, China, 200025
Active, not recruiting
Shanghai, China, 200032
Active, not recruiting
Shijiazhuang, China, 050035
Colombia
Terminated
Bogota, Colombia
Active, not recruiting
Bogota, Colombia, 11001
Active, not recruiting
Medellin-Antioquia, Colombia
Active, not recruiting
Monteria, Colombia
Czech Republic
Active, not recruiting
Hradec Kralove, Czech Republic, 500 05
Active, not recruiting
Olomouc, Czech Republic, 775 20
Active, not recruiting
Praha 2, Czech Republic, 128 08
France
Active, not recruiting
Avignon, France, 84918
Active, not recruiting
Besancon, France, 25030
Active, not recruiting
Bordeaux, France, 33076
Terminated
Bordeaux, France, 33077
Active, not recruiting
Bourg En Bresse, France, 01012
Active, not recruiting
Caen, France, 14076
Active, not recruiting
Clermont Ferrand, France, 63011
Active, not recruiting
Le Mans, France, 72015
Active, not recruiting
Marseille, France, 13273
Active, not recruiting
Montpellier, France, 34298
Recruiting
Paris, France, 75231
Active, not recruiting
Paris, France, 75475
Active, not recruiting
Paris, France, 75970
Active, not recruiting
Rouen, France, 76038
Active, not recruiting
St Cloud, France, 92210
Active, not recruiting
Strasbourg, France, 67065
Active, not recruiting
Villejuif, France, 94805
Germany
Active, not recruiting
Augsburg, Germany, 86150
Active, not recruiting
Berlin, Germany, 10367
Active, not recruiting
Berlin, Germany, 10707
Active, not recruiting
Berlin, Germany, 13125
Active, not recruiting
Berlin, Germany, 14169
Active, not recruiting
Bielefeld, Germany, 33604
Active, not recruiting
Böblingen, Germany, 71032
Terminated
Chemnitz, Germany, 09116
Active, not recruiting
Dortmund, Germany, 44137
Terminated
Dortmund, Germany, 44137
Active, not recruiting
Düsseldorf, Germany, 40235
Active, not recruiting
Erlangen, Germany, 91054
Active, not recruiting
Essen, Germany, 45122
Active, not recruiting
Essen, Germany, 45136
Active, not recruiting
Esslingen, Germany, 73730
Terminated
Frankfurt, Germany, 60431
Active, not recruiting
Frankfurt, Germany, 60596
Active, not recruiting
Frankfurt am Main, Germany, 60389
Active, not recruiting
Freiburg, Germany, 79106
Terminated
Fürth, Germany, 90766
Active, not recruiting
Gelsenkirchen, Germany, 45879
Active, not recruiting
Greifswald, Germany, 17475
Active, not recruiting
Halle, Germany, 06110
Active, not recruiting
Halle, Germany, 06120
Active, not recruiting
Hamburg, Germany, 20357
Active, not recruiting
Hamm, Germany, 59073
Completed
Hannover, Germany, 30177
Active, not recruiting
Hannover, Germany, 30559
Active, not recruiting
Hannover, Germany, 30625
Active, not recruiting
Heidelberg, Germany, 69120
Terminated
Karlsruhe, Germany, 76135
Active, not recruiting
Kassel, Germany, 34117
Active, not recruiting
Kassel, Germany, 34125
Active, not recruiting
Kiel, Germany, 24105
Active, not recruiting
Koeln, Germany, 50935
Active, not recruiting
Köln, Germany, 51067
Active, not recruiting
Lebach, Germany, 66822
Terminated
Limburg, Germany, 65549
Terminated
Lörrach, Germany, 79539
Terminated
Minden, Germany, 32429
Active, not recruiting
München, Germany, 80337
Active, not recruiting
München, Germany, 80638
Terminated
Münster, Germany, 48149
Active, not recruiting
Nordhausen, Germany, 99734
Active, not recruiting
Offenbach, Germany, 63069
Active, not recruiting
Paderborn, Germany, 33098
Active, not recruiting
Recklinghausen, Germany, 45657
Active, not recruiting
Reutlingen, Germany, 72764
Active, not recruiting
Rostock, Germany, 18059
Active, not recruiting
Stralsund, Germany, 18435
Active, not recruiting
Stuttgart, Germany, 70376
Completed
Traunstein, Germany, 83278
Active, not recruiting
Tübingen, Germany, 72076
Active, not recruiting
Ulm, Germany, 89075
Active, not recruiting
Wiesbaden, Germany, 65199
Active, not recruiting
Witten, Germany, 58452
Active, not recruiting
Würzburg, Germany, 97080
Greece
Recruiting
Heraklion, Crete, Greece, 71110
Active, not recruiting
Thessaloniki, Greece, 54645
Guatemala
Active, not recruiting
Guatemala, Guatemala, 01010
Active, not recruiting
Guatemala City, Guatemala, 01015
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong, 852
Active, not recruiting
Hong Kong, Hong Kong
Ireland
Active, not recruiting
Cork, Ireland
Active, not recruiting
Dublin, Ireland, 4
Active, not recruiting
Dublin, Ireland, 7
Active, not recruiting
Dublin, Ireland, 9
Active, not recruiting
Galway, Ireland
Active, not recruiting
Limerick, Ireland
Israel
Active, not recruiting
Beer Sheva, Israel, 8410101
Active, not recruiting
Jerusalem, Israel, 9112001
Active, not recruiting
Jerusalem, Israel, 9372212
Active, not recruiting
Petach Tikva, Israel, 4941492
Active, not recruiting
Ramat Gan, Israel, 5262100
Active, not recruiting
Rehovot, Israel, 7610001
Italy
Active, not recruiting
Napoli, Campania, Italy, 80131
Active, not recruiting
Bologna, Emilia-Romagna, Italy, 40138
Active, not recruiting
Bologna, Emilia-Romagna, Italy, 40139
Recruiting
Roma, Lazio, Italy, 00128
Active, not recruiting
Roma, Lazio, Italy, 00189
Active, not recruiting
Genova, Liguria, Italy, 16132
Active, not recruiting
Bergamo, Lombardia, Italy, 24128
Active, not recruiting
Cremona, Lombardia, Italy, 26100
Active, not recruiting
Milano, Lombardia, Italy, 20133
Active, not recruiting
Milano, Lombardia, Italy, 20132
Active, not recruiting
Milano, Lombardia, Italy, 20141
Active, not recruiting
Monza, Lombardia, Italy, 20900
Active, not recruiting
Rozzano, Lombardia, Italy, 20089
Active, not recruiting
Macerata, Marche, Italy, 62100
Recruiting
Candiolo, Piemonte, Italy, 10060
Active, not recruiting
Brindisi, Puglia, Italy, 72100
Active, not recruiting
San Giovanni Rotondo, Puglia, Italy, 71013
Active, not recruiting
Pisa, Toscana, Italy, 56100
Recruiting
Pontedera, Toscana, Italy, 56025
Active, not recruiting
Padova, Veneto, Italy, 35128
Active, not recruiting
Verona, Veneto, Italy, 37126
Mexico
Active, not recruiting
Aguascalientes, Mexico, 20230
Active, not recruiting
Distrito Federal, Mexico, 14080
Active, not recruiting
Mexico City, Mexico, 06760
Recruiting
Mexico City, Mexico, 14080
Active, not recruiting
Oaxaca, Mexico, 68000
Panama
Recruiting
Panama, Panama, 0834-02723
Active, not recruiting
Panama City, Panama, 0832-00752
Peru
Active, not recruiting
Arequipa, Peru, 04001
Active, not recruiting
Bellavista, Peru, Callao 2
Active, not recruiting
Lima, Peru, 13
Active, not recruiting
Lima, Peru, Lima 41
Terminated
Miraflores, Peru, Lima 18
Serbia
Active, not recruiting
Belgrade, Serbia, 11000
Terminated
Kragujevac, Serbia, 34000
Active, not recruiting
Sremska Kamenica, Serbia, 21204
South Africa
Active, not recruiting
Johannesburg, South Africa, 2193
Active, not recruiting
Johannesburg, South Africa, 2196
Active, not recruiting
Kraaifontein, South Africa, 7570
Recruiting
Pietermaritzburg, South Africa, 3201
Active, not recruiting
Port Elizabeth, South Africa, 6045
Active, not recruiting
Pretoria, South Africa, 0081
Spain
Terminated
Terrassa, Barcelona, Spain, 08221
Terminated
Cádiz, Cadiz, Spain, 11009
Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Terminated
Alcorcon, Madrid, Spain, 28922
Active, not recruiting
Leganes, Madrid, Spain, 28911
Recruiting
Vigo, Pontevedra, Spain, 36312
Active, not recruiting
Reus, Tarragona, Spain, 43204
Active, not recruiting
Barcelona, Spain, 08036
Active, not recruiting
Madrid, Spain, 28046
Active, not recruiting
Madrid, Spain, 28050
Active, not recruiting
Malaga, Spain, 29010
Active, not recruiting
Navarra, Spain, 31008
Active, not recruiting
Salamanca, Spain, 37007
Active, not recruiting
Sevilla, Spain, 41013
Terminated
Valencia, Spain, 41014
Active, not recruiting
Valencia, Spain, 46009
Active, not recruiting
Valencia, Spain, 46017
Sweden
Active, not recruiting
Gävle, Sweden, 80187
Active, not recruiting
Lund, Sweden, 22185
Active, not recruiting
Stockholm, Sweden, 17176
Switzerland
Active, not recruiting
Aarau, Switzerland, 5001
Active, not recruiting
Zürich, Switzerland, 8008
Taiwan
Active, not recruiting
Taichung, Taiwan, 407
Active, not recruiting
Taipei, Taiwan, 00112
Active, not recruiting
Taipei, Taiwan, 100
Active, not recruiting
Taipei, Taiwan, 112
Active, not recruiting
Taoyuan, Taiwan, 333
Turkey
Recruiting
Bursa, Turkey, 16059
Active, not recruiting
Edirne, Turkey, 22770
Recruiting
Istanbul, Turkey, 34000
Active, not recruiting
Izmir, Turkey, 35100
Active, not recruiting
Malatya, Turkey, 44280
United Kingdom
Active, not recruiting
Birmingham, United Kingdom, B15 2TH
Active, not recruiting
Bradford, United Kingdom, BD9 6RJ
Active, not recruiting
Bristol, United Kingdom, BS2 8ED
Active, not recruiting
Cottingham, United Kingdom, HU16 5JG
Active, not recruiting
Devon, United Kingdom, EX31 4JB
Active, not recruiting
Dundee, United Kingdom, DD1 9SY
Active, not recruiting
Huddersfield, United Kingdom, HD3 3EA
Active, not recruiting
Leeds, United Kingdom, LS9 7TF
Active, not recruiting
London, United Kingdom, SE1 7EH
Active, not recruiting
London, United Kingdom, W6 8RF
Active, not recruiting
Manchester, United Kingdom, M2O 4BX
Active, not recruiting
Nottingham, United Kingdom, NG5 1PB
Active, not recruiting
Sheffield, United Kingdom, S10 2SJ
Active, not recruiting
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
German Breast Group
NSABP Foundation Inc
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01772472     History of Changes
Other Study ID Numbers: BO27938  2012-002018-37 
Study First Received: January 17, 2013
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Ado-trastuzumab emtansine
Maytansine
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on February 08, 2016