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 August 2014 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: August 26, 2014
Last verified: August 2014
  Purpose

This 2-arm, randomized, open-label study will evaluate the efficacy and safety o f trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axi llary lymph nodes following preoperative therapy. Eligible patients will be rand omized 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 w ill 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
Recruiting
Long Beach, California, United States, 90806
Recruiting
Orange, California, United States, 92868
Recruiting
San Diego, California, United States, 92120
Recruiting
Santa Ana, California, United States, 92705
Recruiting
Stanford, California, United States, 94305-5236
Recruiting
Vallejo, California, United States, 94589
United States, Colorado
Recruiting
Colorado Springs, Colorado, United States, 80909
Recruiting
Denver, Colorado, United States, 80222
Recruiting
Denver, Colorado, United States, 80205
Recruiting
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Recruiting
Hartford, Connecticut, United States, 06102
Recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Recruiting
Gainesville, Florida, United States, 32610
Recruiting
Jacksonville, Florida, United States, 32207
Recruiting
Miami Beach, Florida, United States, 33140
Recruiting
Orlando, Florida, United States, 32806
Recruiting
Tampa, Florida, United States, 33612-9497
United States, Georgia
Recruiting
Albany, Georgia, United States, 31701
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60612
Recruiting
Naperville, Illinois, United States, 60540
Recruiting
Plainfield, Illinois, United States, 60585
United States, Kentucky
Recruiting
Lexington, Kentucky, United States, 40536
Completed
Louisville, Kentucky, United States, 40202
United States, Maine
Recruiting
Augusta, Maine, United States, 04330
Recruiting
Brewer, Maine, United States, 04412
Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21237
Recruiting
Baltimore, Maryland, United States, 21204
Active, not recruiting
Baltimore, Maryland, United States, 21202
Recruiting
Baltimore, Maryland, United States, 21218
Not yet recruiting
Bethesda, Maryland, United States, 20817
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48202
Recruiting
Detroit, Michigan, United States, 48201
Recruiting
Grand Rapids, Michigan, United States, 49503
Recruiting
Lansing, Michigan, United States, 48910
Recruiting
Owosso, Michigan, United States, 48867
Recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Recruiting
Joplin, Missouri, United States, 64804
Recruiting
Springfield, Missouri, United States, 65804
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Recruiting
Long Branch, New Jersey, United States, 07740
Recruiting
New Brunswick, New Jersey, United States, 08901
Recruiting
Newark, New Jersey, United States, 07112
Recruiting
Sparta, New Jersey, United States, 07871-1791
United States, New York
Recruiting
Glenn Falls, New York, United States, 12801
Recruiting
New York, New York, United States, 10032
Recruiting
Stony Brook, New York, United States, 11794
Recruiting
Troy, New York, United States, 12180
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States, 28204-2839
Recruiting
Concord, North Carolina, United States, 28025
Recruiting
Monroe, North Carolina, United States, 28211
Recruiting
Shelby, North Carolina, United States, 28150
United States, North Dakota
Recruiting
Fargo, North Dakota, United States, 58122-9988
United States, Ohio
Recruiting
Akron, Ohio, United States, 44304
Recruiting
Canton, Ohio, United States, 44710
Recruiting
Cleveland, Ohio, United States, 44111
Recruiting
Cleveland, Ohio, United States, 44195
Recruiting
Cleveland, Ohio, United States, 44106-5067
Recruiting
Cleveland, Ohio, United States, 52242-1086
Recruiting
Columbus, Ohio, United States, 43210
Recruiting
Mayfield Heights, Ohio, United States, 44124
Recruiting
Mentor, Ohio, United States, 44060
United States, Oregon
Active, not recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Recruiting
East Stroudsburg, Pennsylvania, United States, 18301
Recruiting
Ephrata, Pennsylvania, United States, 17543
Recruiting
Philadelphia, Pennsylvania, United States, 19107
Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Recruiting
York, Pennsylvania, United States, 17403
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29425
United States, South Dakota
Recruiting
Sioux Falls, South Dakota, United States, 57105
Recruiting
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Recruiting
Knoxville, Tennessee, United States, 37916-2305
United States, Texas
Recruiting
Houston, Texas, United States, 77030
Not yet recruiting
Houston, Texas, United States, 77030
Recruiting
Lubbock, Texas, United States, 79410
United States, Virginia
Recruiting
Fredericksburg, Virginia, United States, 22408
Recruiting
Lynchburg, Virginia, United States, 24501
Recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Recruiting
Issaquah, Washington, United States, 98029
Recruiting
Kirkland, Washington, United States, 98034
Recruiting
Mount Vernon, Washington, United States, 98273
Recruiting
Seattle, Washington, United States, 98101
Recruiting
Spokane, Washington, United States, 99204
United States, Wisconsin
Recruiting
Marshfield, Wisconsin, United States, 54449
Recruiting
Milwaukee, Wisconsin, United States, 53215
Argentina
Terminated
Buenos Aires, Argentina, C1122AAL
Recruiting
La Rioja, Argentina, F5300COE
Recruiting
Rosario, Argentina, S2000KZE
Austria
Not yet recruiting
Innsbruck, Austria, 6020
Not yet recruiting
Salzburg, Austria, 5020
Recruiting
Wien, Austria, 1090
Active, not recruiting
Wien, Austria, 1090
Belgium
Not yet recruiting
Brussels, Belgium, 1200
Recruiting
Gent, Belgium, 9000
Recruiting
Liege, Belgium, 4000
Recruiting
Wilrijk, Belgium, 2610
Brazil
Recruiting
Curitiba, PR, Brazil, 80530-010
Recruiting
Rio De Janeiro, RJ, Brazil, 22290-160
Recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Recruiting
Porto Alegre, RS, Brazil, 90035-001
Recruiting
Porto Alegre, RS, Brazil, 90540-140
Not yet recruiting
Barretos, SP, Brazil, 14784-400
Not yet recruiting
Jau, SP, Brazil, 17210-080
Not yet recruiting
Sao Jose dos Campos, SP, Brazil, 12245-750
Recruiting
Sao Paulo, SP, Brazil, 01321-001
Recruiting
Sao Paulo, SP, Brazil, 01236-030
Recruiting
Sao Paulo, SP, Brazil, 01246-000
Recruiting
Sao Paulo, SP, Brazil, 01321-000
Canada, Alberta
Recruiting
Calgary, Alberta, Canada, T2N 4N2
Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Recruiting
London, Ontario, Canada, N6A 4L6
Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
Recruiting
Montreal, Quebec, Canada, H3G 1A4
Recruiting
Montreal, Quebec, Canada, H2W 1T8
Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Colombia
Recruiting
Bogota, Colombia
Active, not recruiting
Bogota, Colombia, 11001
Recruiting
Medellin-Antioquia, Colombia
Recruiting
Monteria, Colombia
Czech Republic
Recruiting
Hradec Kralove, Czech Republic, 500 05
Recruiting
Olomouc, Czech Republic, 775 20
Recruiting
Praha, Czech Republic, 128 08
France
Recruiting
Avignon, France, 84918
Recruiting
Besancon, France, 25030
Recruiting
Bordeaux, France, 33076
Recruiting
Bordeaux, France, 33077
Recruiting
Bourg En Bresse, France, 01012
Recruiting
Caen, France, 14076
Recruiting
Clermont Ferrand, France, 63011
Recruiting
Le Mans, France, 72015
Recruiting
Marseille, France, 13273
Recruiting
Montpellier, France, 34298
Recruiting
Paris, France, 75231
Recruiting
Paris, France, 75970
Recruiting
Paris, France, 75475
Recruiting
Rouen, France, 76038
Recruiting
St Cloud, France, 92210
Recruiting
Strasbourg, France, 67065
Recruiting
Villejuif, France, 94805
Germany
Recruiting
Augsburg, Germany, 86150
Recruiting
Berlin, Germany, 10367
Recruiting
Berlin, Germany, 13125
Recruiting
Berlin, Germany, 10707
Recruiting
Berlin, Germany, 14169
Recruiting
Bielefeld, Germany, 33604
Recruiting
Böblingen, Germany, 71032
Terminated
Chemnitz, Germany, 09116
Recruiting
Dortmund, Germany, 44137
Terminated
Dortmund, Germany, 44137
Recruiting
Düsseldorf, Germany, 40235
Recruiting
Erlangen, Germany, 91054
Recruiting
Essen, Germany, 45136
Recruiting
Essen, Germany, 45122
Recruiting
Esslingen, Germany, 73730
Recruiting
Frankfurt, Germany, 60596
Terminated
Frankfurt, Germany, 60431
Recruiting
Frankfurt am Main, Germany, 60389
Recruiting
Freiburg, Germany, 79106
Terminated
Fürth, Germany, 90766
Recruiting
Gelsenkirchen, Germany, 45879
Recruiting
Greifswald, Germany, 17475
Recruiting
Halle, Germany, 06120
Recruiting
Halle, Germany, 06110
Recruiting
Hamburg, Germany, 20357
Recruiting
Hamm, Germany, 59073
Recruiting
Hannover, Germany, 30625
Recruiting
Hannover, Germany, 30559
Completed
Hannover, Germany, 30177
Recruiting
Heidelberg, Germany, 69120
Recruiting
Karlsruhe, Germany, 76135
Recruiting
Kassel, Germany, 34125
Active, not recruiting
Kassel, Germany, 34117
Recruiting
Kiel, Germany, 24105
Recruiting
Koeln, Germany, 50935
Recruiting
Köln, Germany, 51067
Recruiting
Lebach, Germany, 66822
Terminated
Limburg, Germany, 65549
Recruiting
Lörrach, Germany, 79539
Recruiting
Minden, Germany, 32429
Recruiting
München, Germany, 80638
Recruiting
München, Germany, 80337
Terminated
Münster, Germany, 48149
Recruiting
Nordhausen, Germany, 99734
Recruiting
Offenbach, Germany, 63069
Recruiting
Paderborn, Germany, 33098
Recruiting
Recklinghausen, Germany, 45657
Recruiting
Reutlingen, Germany, 72764
Recruiting
Rostock, Germany, 18059
Recruiting
Stralsund, Germany, 18435
Active, not recruiting
Stuttgart, Germany, 70376
Recruiting
Traunstein, Germany, 83278
Recruiting
Tübingen, Germany, 72076
Recruiting
Ulm, Germany, 89075
Recruiting
Wiesbaden, Germany, 65199
Recruiting
Witten, Germany, 58452
Recruiting
Würzburg, Germany, 97080
Greece
Recruiting
Heraklion, Greece, 711 10
Not yet recruiting
Thessaloniki, Greece, 54645
Guatemala
Recruiting
Guatemala, Guatemala, 01009
Recruiting
Guatemala City, Guatemala, 01015
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong, 852
Recruiting
Hong Kong, Hong Kong, 852
Recruiting
Hong Kong, Hong Kong
Ireland
Recruiting
Cork, Ireland
Recruiting
Dublin, Ireland, 4
Active, not recruiting
Dublin, Ireland, 7
Recruiting
Dublin, Ireland, 9
Recruiting
Galway, Ireland
Recruiting
Limerick, Ireland
Israel
Recruiting
Beer Sheva, Israel, 8410101
Recruiting
Jerusalem, Israel, 9112001
Not yet recruiting
Jerusalem, Israel, 9372212
Not yet recruiting
Petach Tikva, Israel, 4941492
Active, not recruiting
Ramat Gan, Israel, 52620-00
Not yet recruiting
Rehovot, Israel, 7610001
Italy
Recruiting
Napoli, Campania, Italy, 80131
Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Recruiting
Bologna, Emilia-Romagna, Italy, 40139
Recruiting
Roma, Lazio, Italy, 00189
Recruiting
Genova, Liguria, Italy, 16132
Recruiting
Bergamo, Lombardia, Italy, 24128
Recruiting
Cremona, Lombardia, Italy, 26100
Recruiting
Milano, Lombardia, Italy, 20141
Recruiting
Milano, Lombardia, Italy, 20132
Recruiting
Milano, Lombardia, Italy, 20133
Recruiting
Monza, Lombardia, Italy, 20052
Recruiting
Candiolo, Piemonte, Italy, 10060
Recruiting
Brindisi, Puglia, Italy, 72100
Recruiting
Pisa, Toscana, Italy, 56100
Recruiting
Padova, Veneto, Italy, 35128
Mexico
Active, not recruiting
Aguascalientes, Mexico, 20230
Recruiting
Distrito Federal, Mexico, 14080
Recruiting
Mexico City, Mexico, 06760
Recruiting
Mexico City, Mexico, 14080
Recruiting
Oaxaca, Mexico, 68000
Panama
Recruiting
Panama, Panama, 0834-02723
Active, not recruiting
Panama City, Panama, 32400
Peru
Recruiting
Arequipa, Peru, 04001
Not yet recruiting
Bellavista, Peru, Callao 2
Not yet recruiting
Lima, Peru, 13
Recruiting
Lima, Peru, Lima 41
Recruiting
Miraflores, Peru, Lima 18
Serbia
Recruiting
Belgrade, Serbia, 11000
Recruiting
Kragujevac, Serbia, 34000
Recruiting
Sremska Kamenica, Serbia, 21204
South Africa
Recruiting
Johannesburg, South Africa, 2196
Recruiting
Johannesburg, South Africa, 2193
Recruiting
Kraaifontein, South Africa, 7570
Recruiting
Pietermaritzburg, South Africa, 3201
Recruiting
Port Elizabeth, South Africa, 6045
Recruiting
Pretoria, South Africa, 0081
Spain
Terminated
Terrassa, Barcelona, Spain, 08221
Terminated
Cádiz, Cadiz, Spain, 11009
Not yet recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Terminated
Alcorcon, Madrid, Spain, 28922
Recruiting
Leganes, Madrid, Spain, 28911
Recruiting
Vigo, Pontevedra, Spain, 36204
Recruiting
Reus, Tarragona, Spain, 43204
Not yet recruiting
Barcelona, Spain, 08036
Not yet recruiting
Madrid, Spain, 28050
Recruiting
Madrid, Spain, 28046
Recruiting
Malaga, Spain, 29010
Recruiting
Navarra, Spain, 31008
Not yet recruiting
Salamanca, Spain, 37007
Recruiting
Sevilla, Spain, 41013
Terminated
Valencia, Spain, 41014
Recruiting
Valencia, Spain, 46017
Not yet recruiting
Valencia, Spain, 46009
Sweden
Recruiting
Gävle, Sweden, 80187
Recruiting
Lund, Sweden, 22185
Recruiting
Stockholm, Sweden, 17176
Switzerland
Active, not recruiting
Aarau, Switzerland, 5001
Recruiting
Zürich, Switzerland, 8008
Taiwan
Recruiting
Taichung, Taiwan, 407
Recruiting
Taipei, Taiwan, 100
Recruiting
Taipei, Taiwan, 00112
Recruiting
Taipei, Taiwan, 112
Recruiting
Taipei, Taiwan, 105
Turkey
Recruiting
Bursa, Turkey, 16059
Recruiting
Istanbul, Turkey, 34000
Active, not recruiting
Izmir, Turkey, 35100
Active, not recruiting
Malatya, Turkey, 44280
United Kingdom
Recruiting
Birmingham, United Kingdom, B15 2TH
Recruiting
Bradford, United Kingdom, BD9 6RJ
Recruiting
Bristol, United Kingdom, BS2 8ED
Recruiting
Cottingham, United Kingdom, HU16 5JG
Recruiting
Devon, United Kingdom, EX31 4JB
Recruiting
Dundee, United Kingdom, DD1 9SY
Recruiting
Huddersfield, United Kingdom, HD3 3EA
Recruiting
Leeds, United Kingdom, LS9 7TF
Active, not recruiting
London, United Kingdom, SE1 7EH
Active, not recruiting
London, United Kingdom, W6 8RF
Recruiting
Manchester, United Kingdom, M2O 4BX
Recruiting
Nottingham, United Kingdom, NG5 1PB
Recruiting
Sheffield, United Kingdom, S10 2SJ
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: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014