A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Collaborators:
Breast International Group
Genentech
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358877
First received: May 20, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (trastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously (iv) every 3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin (trastuzumab) iv every 3 weeks. Anticipated time on study treatment is 52 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).


Condition Intervention Phase
Breast Cancer
Drug: pertuzumab
Drug: placebo
Drug: trastuzumab [Herceptin]
Drug: Chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter, Double-blind, Placebo-controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Invasive disease-free survival (IDFS) [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IDFS including second non-breast cancer [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Disease-free survival (DFS), including second non-breast cancer or contralateral or ipsilateral ductal carcinoma in situ [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Recurrence-free interval (RFI): time between randomization and local, regional or distant breast cancer recurrence [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Distant recurrence-free interval (DRFI): time between randomization and distant breast cancer recurrence [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Cardiac and overall safety: Incidence of adverse events [ Time Frame: up to 13 years ] [ Designated as safety issue: No ]
  • Quality of life: EORTC QLQ-C30, QLQ-BR23 and EQ-5D questionnaires [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 4800
Study Start Date: November 2011
Estimated Study Completion Date: March 2024
Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pertuzumab
840 mg iv loading dose in Cycle 1, followed by 420 mg iv every 3 weeks, 52 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose in Cycle 1, followed by 6 mg/kg iv every 3 weeks, 52 weeks
Drug: Chemotherapy
6-8 cycles of standard chemotherapy (non-anthracycline based or anthracycline-based)
Placebo Comparator: 2 Drug: placebo
iv every 3 weeks, 52 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv loading dose in Cycle 1, followed by 6 mg/kg iv every 3 weeks, 52 weeks
Drug: Chemotherapy
6-8 cycles of standard chemotherapy (non-anthracycline based or anthracycline-based)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients. >/= 18 years of age
  • Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised and that is node-positive (except T0)
  • Eastern Cooperative Oncology Group (ECOG) performance status </=1
  • The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first.
  • Known hormone receptor status (estrogen receptor and progesterone receptor)
  • Baseline LVEF >/= 55%
  • Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • History of any prior (ipsi- and/or contralateral) invasive breast cancer
  • History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any "clinical" T4 tumor as defined by TNM, including inflammatory breast cancer
  • Any previous systemic chemotherapy for cancer or radiotherapy for cancer
  • Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
  • Concurrent anti-cancer treatment in another investigational trial
  • Serious cardiac or cardiovascular disease or condition
  • Pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358877

Contacts
Contact: Please reference Study ID Number: BO25126 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, Arizona
Terminated
Scottsdale, Arizona, United States, 85025
Recruiting
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Terminated
Jonesboro, Arkansas, United States, 72401
United States, California
Recruiting
Everett, California, United States, 98208
Recruiting
Greenbrae, California, United States, 94904
Recruiting
Hayward, California, United States, 94545
Recruiting
La Jolla, California, United States, 92093
Recruiting
Los Angeles, California, United States, 90048
Recruiting
Oakland, California, United States, 94611
Recruiting
Roseville, California, United States, 95661
Recruiting
Sacramento, California, United States, 95825
Recruiting
Sacramento, California, United States, 95816
Recruiting
San Diego, California, United States, 92108
Completed
San Francisco, California, United States, 94115
Recruiting
San Francisco, California, United States, 94115
Recruiting
San Jose, California, United States, 95119
Recruiting
Santa Clara, California, United States, 95051
Recruiting
South San Francisco, California, United States, 94080
Recruiting
Vallejo, California, United States, 94589
Active, not recruiting
Walnut Creek, California, United States, 94596
United States, Colorado
Active, not recruiting
Denver, Colorado, United States, 80220
Recruiting
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Recruiting
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Active, not recruiting
Washington, District of Columbia, United States, 20016-1468
Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Recruiting
Fort Myers, Florida, United States, 33916
Active, not recruiting
Hollywood, Florida, United States, 33021
Recruiting
Jacksonville, Florida, United States, 32224
Recruiting
Jacksonville, Florida, United States, 32256
Terminated
Lakeland, Florida, United States, 33805
Recruiting
Ocala, Florida, United States, 34474
Recruiting
Pembroke Pines, Florida, United States, 33028
Recruiting
Port Saint Lucie, Florida, United States, 34952
Active, not recruiting
St Petersburg, Florida, United States, 33719
Recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
Recruiting
Albany, Georgia, United States, 31701
Recruiting
Atlanta, Georgia, United States, 30341
Recruiting
Marietta, Georgia, United States, 30060
United States, Idaho
Recruiting
Post Falls, Idaho, United States, 83854
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60612
Recruiting
Chicago, Illinois, United States, 60637
Recruiting
Decatur, Illinois, United States, 62526
Recruiting
Harvey, Illinois, United States, 60426
Recruiting
Maywood, Illinois, United States, 60153
Recruiting
Naperville, Illinois, United States, 60540
Recruiting
Peoria, Illinois, United States, 61615
Active, not recruiting
Plainfield, Illinois, United States, 60585
Active, not recruiting
Quincy, Illinois, United States, 62301
Recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Active, not recruiting
Iowa City, Iowa, United States, 52242
Recruiting
Sioux City, Iowa, United States, 51108
United States, Kansas
Active, not recruiting
Wichita, Kansas, United States, 67214
United States, Louisiana
Recruiting
Lafayette, Louisiana, United States, 70503
United States, Maine
Recruiting
Bangor, Maine, United States, 04401
Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21202
Terminated
Baltimore, Maryland, United States, 21201
Recruiting
Baltimore, Maryland, United States, 21237
Terminated
Bethesda, Maryland, United States, 20817
Active, not recruiting
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States, 02215
Recruiting
Boston, Massachusetts, United States, 02215
Recruiting
Boston, Massachusetts, United States, 02118
Recruiting
Boston, Massachusetts, United States, 02114
Active, not recruiting
Boston, Massachusetts, United States, 02130
Recruiting
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Recruiting
Grand Rapids, Michigan, United States, 49503
Recruiting
Kalamazoo, Michigan, United States, 49007
Completed
Traverse City, Michigan, United States, 49614
United States, Minnesota
Active, not recruiting
Edina, Minnesota, United States, 55414
Terminated
Rochester, Minnesota, United States, 55905
Recruiting
Saint Louis Park, Minnesota, United States, 55426
Recruiting
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
Recruiting
St. Louis, Missouri, United States, 63131
United States, Montana
Terminated
Billings, Montana, United States, 59101
United States, Nebraska
Recruiting
Lincoln, Nebraska, United States, 68510
Recruiting
Omaha, Nebraska, United States, 68106
United States, Nevada
Recruiting
Syracuse, Nevada, United States, 13210
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States, 03756
Terminated
Manchester, New Hampshire, United States, 03102
United States, New Jersey
Terminated
Basking Ridge, New Jersey, United States, 07920
Active, not recruiting
Livingston, New Jersey, United States, 07039
United States, New York
Active, not recruiting
Albany, New York, United States, 12206
Recruiting
Bronx, New York, United States, 10467
Recruiting
Buffalo, New York, United States, 14263
Terminated
Commack, New York, United States, 11725
Recruiting
New York, New York, United States, 10019
Recruiting
New York, New York, United States, 10003
Recruiting
New York, New York, United States, 10011
Active, not recruiting
New York, New York, United States, 10065-6007
Terminated
Rockville Centre, New York, United States, 11570
Terminated
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States, 27599
Recruiting
Hickory, North Carolina, United States, 28602
United States, North Dakota
Terminated
Fargo, North Dakota, United States, 58122-9988
United States, Ohio
Terminated
Akron, Ohio, United States, 44304
Recruiting
Cincinnati, Ohio, United States, 45242
Recruiting
Columbus, Ohio, United States, 43219
Active, not recruiting
Dayton, Ohio, United States, 45420
Active, not recruiting
Toledo, Ohio, United States, 43617
United States, Oregon
Active, not recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19141
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Terminated
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Terminated
Providence, Rhode Island, United States, 02906
Terminated
Providence, Rhode Island, United States, 02903
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29406
Recruiting
Charleston, South Carolina, United States, 29403-5740
Recruiting
Columbia, South Carolina, United States, 65203
Recruiting
Columbia, South Carolina, United States, 29210
Active, not recruiting
Greenville, South Carolina, United States, 29615
United States, South Dakota
Recruiting
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Recruiting
Bristol, Tennessee, United States, 37620
Recruiting
Chattanooga, Tennessee, United States, 37404
Terminated
Kingsport, Tennessee, United States, 37660
Recruiting
Nashville, Tennessee, United States, 37204
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Terminated
Dallas, Texas, United States, 75390-8852
Recruiting
Dallas, Texas, United States, 75231
Active, not recruiting
Dallas, Texas, United States, 75246
Recruiting
Dallas, Texas, United States, 75230
Active, not recruiting
El Paso, Texas, United States, 79902
Recruiting
Fort Worth, Texas, United States, 76177
Recruiting
Fort Worth, Texas, United States, 76104
Recruiting
Garland, Texas, United States, 77060
Terminated
Houston, Texas, United States, 77030
Recruiting
Houston, Texas, United States, 77024
Recruiting
New Braunfels, Texas, United States, 78130
Recruiting
Plano, Texas, United States, 75075-7787
Recruiting
The Woodlands, Texas, United States, 77380
Active, not recruiting
Tyler, Texas, United States, 75702
United States, Utah
Recruiting
Ogden, Utah, United States, 84403
United States, Virginia
Active, not recruiting
Richmond, Virginia, United States, 23230
United States, Washington
Recruiting
Walla Walla, Washington, United States, 99362
United States, West Virginia
Recruiting
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
Terminated
Green Bay, Wisconsin, United States, 54301
Recruiting
Green Bay, Wisconsin, United States, 54301
Recruiting
Marshfield, Wisconsin, United States, 54449
Argentina
Terminated
Buenos Aires, Argentina, 1185
Terminated
Florencio Varela, Argentina, B1878DVB
Terminated
Rosario, Argentina, S2000DSK
Recruiting
San Miguel de Tucuman, Argentina, T4000IAK
Completed
Santa Fe, Argentina, 03000
Australia
Recruiting
Adelaide, Australia, 5000
Recruiting
Auchenflower, Australia, 4066
Recruiting
East Bentleigh, Australia, VIC 3165
Recruiting
Geelong, Australia, 3220
Recruiting
Heidelberg, Australia, 3084
Recruiting
Hobart, Australia, 7000
Recruiting
Lismore, Australia, 2480
Active, not recruiting
Melbourne, Australia, 3002
Recruiting
Milton, Australia, 4064
Recruiting
Perth, Australia, 6009
Recruiting
Sydney, Australia, 2060
Recruiting
Waratah, Australia, 2298
Austria
Recruiting
Bludesch, Austria, 6712
Recruiting
Graz, Austria, 8036
Active, not recruiting
Innsbruck, Austria, 6020
Recruiting
Linz, Austria, 4010
Active, not recruiting
Salzburg, Austria, 5020
Recruiting
St Veit An Der Glan, Austria, 9300
Active, not recruiting
Vöcklabruck, Austria, 4840
Active, not recruiting
Wels, Austria, 4600
Active, not recruiting
Wien, Austria, 1130
Recruiting
Wien, Austria, 1090
Belgium
Active, not recruiting
Bruxelles, Belgium, 1000
Recruiting
Charleroi, Belgium, 6000
Active, not recruiting
Edegem, Belgium, 2650
Active, not recruiting
Hasselt, Belgium, 3500
Active, not recruiting
Kortrijk, Belgium, 8500
Active, not recruiting
Leuven, Belgium, 3000
Active, not recruiting
Liege, Belgium, 4000
Recruiting
Namur, Belgium, 5000
Active, not recruiting
Wilrijk, Belgium, 2610
Brazil
Not yet recruiting
Curitiba, Brazil, 81520-060
Not yet recruiting
Fortaleza, Brazil, 60336-550
Not yet recruiting
JAU, Brazil, 17210-080
Not yet recruiting
Porto Alegre, Brazil, 90610-000
Not yet recruiting
Rio de Janeiro, Brazil, 20230-130
Not yet recruiting
Sao Paulo, Brazil, 01317-000
Bulgaria
Recruiting
Sofia, Bulgaria, 1527
Active, not recruiting
Sofia, Bulgaria, 1756
Recruiting
Varna, Bulgaria, 9010
Canada, Alberta
Active, not recruiting
Calgary, Alberta, Canada, T2N 4N2
Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Recruiting
Kingston, Ontario, Canada, K7L 5P9
Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Recruiting
Newmarket, Ontario, Canada, L3Y 2R2
Active, not recruiting
Ottawa, Ontario, Canada, K1H 1C4
Recruiting
St. Catharines, Ontario, Canada, L2R 7C6
Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Recruiting
Toronto, Ontario, Canada, M4N 3M5
Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H4J 1C5
Recruiting
Montreal, Quebec, Canada, H2L 4M1
Recruiting
Montreal, Quebec, Canada, H1T 2M4
Active, not recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Canada, Saskatchewan
Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Chile
Recruiting
Santiago, Chile, 7501088
Terminated
Santiago, Chile, 7501239
Active, not recruiting
Santiago, Chile
Terminated
Santiago, Chile, 8380000
China
Recruiting
Beijing, China, 100071
Recruiting
Beijing, China, 100021
Active, not recruiting
Chang Sha, China, 410006
Active, not recruiting
Changchun, China, 130012
Active, not recruiting
Changchun, China, 130021
Recruiting
Chengdu, China, 610072
Active, not recruiting
Fuzhou, China, 110016
Active, not recruiting
Fuzhou, China, 350001
Active, not recruiting
Guangdong Province, China, 510000
Active, not recruiting
Guangzhou, China, 510060
Active, not recruiting
Hangzhou, China, 310003
Active, not recruiting
Harbin, China, 150081
Recruiting
Harbin, China, 150081
Active, not recruiting
Nanchang, China, 330006
Active, not recruiting
Shanghai, China, 200433
Recruiting
Shanghai, China, 200032
Active, not recruiting
Shanghai, China, 200025
Active, not recruiting
Shanghai, China, 200080
Active, not recruiting
Shijiazhuang, China, 50011
Recruiting
Suzhou, China, 215006
Active, not recruiting
Wuhan, China, 430022
Active, not recruiting
Wuhan, China, 430030
Recruiting
Wuhan, China, 430079
Colombia
Active, not recruiting
Bogota, Colombia
Active, not recruiting
Medellin-antioquia, Colombia
Active, not recruiting
Monteria, Colombia
Croatia
Recruiting
Split, Croatia, 21000
Recruiting
Varazdin, Croatia, 42000
Recruiting
Zagreb, Croatia, 10000
Czech Republic
Recruiting
Brno, Czech Republic, 656 53
Recruiting
Hradec Kralove, Czech Republic, 500 05
Active, not recruiting
Olomouc, Czech Republic, 775 20
Recruiting
Pardubice, Czech Republic, 532 03
Denmark
Active, not recruiting
Aalborg, Denmark, 9000
Active, not recruiting
Esbjerg, Denmark, 6700
Active, not recruiting
Herlev, Denmark, 2730
Recruiting
Hillerød, Denmark, 3400
Active, not recruiting
København, Denmark, 2100
Recruiting
Naestved, Denmark, 4700
Active, not recruiting
Odense, Denmark, 5000
Active, not recruiting
Roskilde, Denmark, 4000
Recruiting
Vejle, Denmark, 7100
El Salvador
Active, not recruiting
El Salvador, El Salvador, 01101
Completed
San Salvador, El Salvador, 01101
France
Active, not recruiting
Amiens, France, 80090
Active, not recruiting
Angers, France, 49933
Active, not recruiting
Arras, France, 62012
Active, not recruiting
Avignon, France, 84000
Active, not recruiting
Bordeaux, France, 33076
Active, not recruiting
Bordeaux, France, 33300
Active, not recruiting
Brest, France, 29200
Active, not recruiting
Caen, France, 14076
Active, not recruiting
Clermont-ferrand, France, 63011
Active, not recruiting
Dechy, France, 59187
Active, not recruiting
Dijon, France, 21034
Active, not recruiting
Grenoble, France, 38000
Active, not recruiting
La Roche Sur Yon, France, 85925
Active, not recruiting
Le Havre, France, 76600
Active, not recruiting
Lille, France, 59020
Recruiting
Limoges, France, 87042
Recruiting
Lyon, France, 69373
Active, not recruiting
Marseille, France, 13273
Active, not recruiting
Montpellier, France, 34298
Active, not recruiting
Nancy, France, 54100
Active, not recruiting
Nice, France, 06189
Active, not recruiting
Nimes, France, 30900
Active, not recruiting
Paris, France, 75231
Active, not recruiting
Paris, France, 75651
Active, not recruiting
Perigueux, France, 24000
Active, not recruiting
Poitiers, France, 86021
Active, not recruiting
Reims, France, 51056
Active, not recruiting
Reims, France, 51057
Active, not recruiting
Rennes, France, 35042
Active, not recruiting
Rouen, France, 76038
Active, not recruiting
Saint Brieuc, France, 22015
Active, not recruiting
Saint Herblain, France, 44805
Active, not recruiting
Saint-priest-en-jarez, France, 42271
Active, not recruiting
St Cloud, France, 92210
Active, not recruiting
Strasbourg, France, 67010
Active, not recruiting
Strasbourg, France, 67098
Active, not recruiting
Toulouse, France, 31076
Active, not recruiting
Toulouse, France, 31052
Active, not recruiting
Vandoeuvre-les-nancy, France, 54511
Recruiting
Villejuif, France, 94800
Germany
Recruiting
Amberg, Germany, 92224
Recruiting
Ansbach, Germany, 91522
Active, not recruiting
Bad Nauheim, Germany, 61231
Recruiting
Bergisch Gladbach, Germany, 51465
Active, not recruiting
Berlin, Germany, 4169
Recruiting
Berlin, Germany, 13126
Recruiting
Berlin, Germany, 10716
Recruiting
Bielefeld, Germany, 33602
Active, not recruiting
Bonn, Germany, 53105
Active, not recruiting
Braunschweig, Germany, 38100
Active, not recruiting
Bremen, Germany, 28209
Active, not recruiting
Böblingen, Germany, 71032
Active, not recruiting
Chemnitz, Germany, 09116
Recruiting
Deggendorf, Germany, 94469
Active, not recruiting
Dortmund, Germany, 44137
Active, not recruiting
Dresden, Germany, 01307
Active, not recruiting
Düsseldorf, Germany, 40225
Active, not recruiting
Düsseldorf, Germany, 40235
Recruiting
Erfurt, Germany, 99085
Recruiting
Erlangen, Germany, 91054
Active, not recruiting
Esslingen, Germany, 73730
Recruiting
Frankfurt, Germany, 60596
Active, not recruiting
Frankfurt, Germany, 65929
Recruiting
Frankfurt Am Main, Germany, 60389
Active, not recruiting
Freiburg, Germany, 79110
Active, not recruiting
Fürth, Germany, 90766
Recruiting
Greifswald, Germany, 17487
Not yet recruiting
Göttingen, Germany, 37075
Active, not recruiting
Halle, Germany, 06120
Active, not recruiting
Hamburg, Germany, 20246
Recruiting
Hameln, Germany, 31785
Active, not recruiting
Hannover, Germany, 30177
Active, not recruiting
Hannover, Germany, 30559
Active, not recruiting
Heidelberg, Germany, 69120
Active, not recruiting
Hildesheim, Germany, 31134
Recruiting
Homburg/saar, Germany, 66424
Active, not recruiting
Karlsruhe, Germany, 76135
Recruiting
Kassel, Germany, 34117
Recruiting
Kassel, Germany, 34125
Recruiting
Kiel, Germany, 24105
Active, not recruiting
Koeln, Germany, 50935
Recruiting
Köln, Germany, 50931
Recruiting
Landshut, Germany, 84034
Not yet recruiting
Leipzig, Germany, 04129
Active, not recruiting
Leipzig, Germany, 04277
Active, not recruiting
Ludwigsfelde, Germany, 14974
Active, not recruiting
Lübeck, Germany, 23538
Recruiting
Mainz, Germany, 55131
Recruiting
Muenchen, Germany, 80637
Active, not recruiting
Mönchengladbach, Germany, 41061
Active, not recruiting
München, Germany, 80337
Recruiting
München, Germany, 81675
Recruiting
Münster, Germany, 48149
Recruiting
Offenbach, Germany, 63069
Active, not recruiting
Oldenburg, Germany, 26133
Active, not recruiting
Ravensburg, Germany, 88212
Recruiting
Recklinghausen, Germany, 45657
Active, not recruiting
Rosenheim, Germany, 83022
Active, not recruiting
Rostock, Germany, 18059
Active, not recruiting
Stade, Germany, 21680
Active, not recruiting
Trier, Germany, 54290
Recruiting
Tübingen, Germany, 72076
Recruiting
ULM, Germany, 89075
Recruiting
Velbert, Germany, 42551
Recruiting
Villingen-schwenningen, Germany, 78050
Active, not recruiting
Wiesbaden, Germany, 65189
Active, not recruiting
Witten, Germany, 58452
Active, not recruiting
Würzburg, Germany, 97070
Guatemala
Recruiting
Guatemala City, Guatemala, 01009
Recruiting
Guatemala City, Guatemala, 01015
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong, 852
Hungary
Completed
Budapest, Hungary, 1082
Recruiting
Budapest, Hungary, 1134
Active, not recruiting
Budapest, Hungary, 1122
Recruiting
Debrecen, Hungary, 4012
Recruiting
Gyor, Hungary, 9024
Recruiting
Gyula, Hungary, 5700
Recruiting
Kecskemet, Hungary, 6000
Recruiting
Szeged, Hungary, 6720
Completed
Veszprem, Hungary, 8200
Ireland
Recruiting
Cork, Ireland
Active, not recruiting
Dublin, Ireland, 7
Recruiting
Dublin, Ireland, 9
Recruiting
Dublin, Ireland, 8
Active, not recruiting
Dublin, Ireland, 4
Active, not recruiting
Galway, Ireland
Recruiting
Limerick, Ireland
Israel
Recruiting
Haifa, Israel, 31096
Recruiting
Jerusalem, Israel, 91120
Active, not recruiting
Petach Tikva, Israel, 49100
Active, not recruiting
Ramat Gan, Israel, 52621
Active, not recruiting
Rehovot, Israel, 76100
Active, not recruiting
Tel Aviv, Israel, 64239
Italy
Active, not recruiting
Avellino, Italy, 83100
Active, not recruiting
Aviano, Italy, 33081
Active, not recruiting
Bologna, Italy, 40138
Recruiting
Bolzano, Italy, 39100
Active, not recruiting
Brescia, Italy, 25123
Active, not recruiting
Brindisi, Italy, 72100
Recruiting
Candiolo, Italy, 10060
Active, not recruiting
Carpi, Italy, 41012
Recruiting
Catanzaro, Italy, 88100
Recruiting
Cremona, Italy, 26100
Recruiting
Fano, Italy, 61032
Recruiting
Genova, Italy, 16132
Active, not recruiting
Genova, Italy, 16128
Active, not recruiting
Genova, Italy, 16132
Active, not recruiting
Lecco, Italy, 29300
Recruiting
Legnago, Italy, 37045
Active, not recruiting
Milano, Italy, 20141
Active, not recruiting
Monza, Italy, 20052
Recruiting
Napoli, Italy, 80131
Active, not recruiting
Napoli, Italy, 80131
Active, not recruiting
Pavia, Italy, 27100
Active, not recruiting
Perugia, Italy, 06132
Active, not recruiting
Prato, Italy, 59100
Recruiting
Reggio Emilia, Italy, 42100
Active, not recruiting
Rozzano, Italy, 20089
Active, not recruiting
Saronno, Italy, 21047
Recruiting
Terni, Italy, 05100
Active, not recruiting
Udine, Italy, 33100
Active, not recruiting
Viterbo, Italy, 01100
Japan
Active, not recruiting
Aichi, Japan, 464-8681
Active, not recruiting
Chiba, Japan, 277-8577
Active, not recruiting
Chiba, Japan, 260-0801
Active, not recruiting
Ehime, Japan, 791-0280
Active, not recruiting
Fukuoka, Japan, 811-1395
Active, not recruiting
Gunma, Japan, 371-8511
Active, not recruiting
Hiroshima, Japan, 730-8518
Active, not recruiting
Iwate, Japan, 020-8505
Active, not recruiting
Kagoshima, Japan, 892-0833
Active, not recruiting
Kanagawa, Japan, 216-8511
Active, not recruiting
Kanagawa, Japan, 259-1193
Active, not recruiting
Kumamoto, Japan, 862-0909
Active, not recruiting
Kyoto, Japan, 606-8507
Active, not recruiting
Niigata, Japan, 951-8566
Active, not recruiting
Osaka, Japan, 537-0025
Active, not recruiting
Osaka, Japan, 540-0006
Active, not recruiting
Saitama, Japan, 362-0806
Active, not recruiting
Saitama, Japan, 350-1298
Active, not recruiting
Shizuoka, Japan, 420-8527
Active, not recruiting
Shizuoka, Japan, 411-8777
Active, not recruiting
Tochigi, Japan, 329-0498
Active, not recruiting
Tokyo, Japan, 160-0023
Active, not recruiting
Tokyo, Japan, 104-0045
Active, not recruiting
Tokyo, Japan, 113-8677
Active, not recruiting
Tokyo, Japan, 135-8550
Korea, Republic of
Active, not recruiting
Seongnam-si, Korea, Republic of, 463-707
Recruiting
Seoul, Korea, Republic of, 135-170
Recruiting
Seoul, Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 130-702
Recruiting
Seoul, Korea, Republic of, 110-744
Recruiting
Seoul, Korea, Republic of, 120-752
Mexico
Terminated
Acapulco, Mexico, 39670
Recruiting
Aguascalientes, Mexico, 20230
Recruiting
Campeche, Cam, Mexico, 24096
Terminated
Chihuahua, Mexico, 31000
Recruiting
Durango, Mexico, 34000
Recruiting
Guadalajara, Mexico, 44670
Recruiting
León, Mexico, 37000
Recruiting
Mexico City, Mexico, 06760
Recruiting
Mexico Df, Mexico, 06726
Active, not recruiting
Monterrey, Mexico, 64710
Recruiting
Monterrey, Mexico, 64020
Recruiting
Oaxaca, Mexico, 68000
Terminated
Obregon, Mexico, 85000
Recruiting
Queretaro, Mexico, 76178
Recruiting
San Luis Potosi, Mexico, 78218
Netherlands
Recruiting
Alkmaar, Netherlands, 1815 JD
Active, not recruiting
Breda, Netherlands, 4819 EV
Recruiting
Delft, Netherlands, 2625 AD
Recruiting
Maastricht, Netherlands, 6229 HX
Recruiting
Zwolle, Netherlands, 8011 JW
New Zealand
Active, not recruiting
Hamilton, New Zealand, 2001
Recruiting
Palmerston North, New Zealand
Panama
Recruiting
Panama, Panama, 0834-02723
Active, not recruiting
Panama City, Panama
Peru
Terminated
Lima, Peru, 1
Terminated
Lima, Peru, Lima 1
Active, not recruiting
Lima, Peru, 34
Recruiting
Lima, Peru, Lima 41
Active, not recruiting
Lima, Peru, L27
Recruiting
Trujillo, Peru, 13011
Philippines
Recruiting
Manila, Philippines, 1008
Active, not recruiting
Pasig City, Philippines, 1605
Active, not recruiting
Quezon City, Luzon, Philippines, 1101
Poland
Active, not recruiting
Bialystok, Poland, 15-027
Recruiting
Bydgoszcz, Poland, 85-796
Recruiting
Gdansk, Poland, 80-952
Recruiting
Opole, Poland, 45-060
Recruiting
Warszawa, Poland, 02-781
Recruiting
Wieliszew, Poland, 05-135
Romania
Recruiting
Bucharest, Romania, 76251
Active, not recruiting
Cluj-napoca, Romania, 400015
Recruiting
Cluj-napoca, Romania, 400015
Recruiting
Iasi, Romania, 700106
Russian Federation
Active, not recruiting
Kazan, Russian Federation, 420029
Recruiting
Moscow, Russian Federation, 115478
Active, not recruiting
Pyatigorsk, Russian Federation, 357502
Active, not recruiting
Samara, Russian Federation, 443066
Recruiting
Stavropol, Russian Federation, 355045
Recruiting
Tula, Russian Federation, 300040
Slovenia
Recruiting
Ljubljana, Slovenia, 1000
South Africa
Active, not recruiting
Bloemfontein, South Africa, 9301
Terminated
Floracliffe, South Africa, 1715
Active, not recruiting
Johannesburg, South Africa, 2193
Recruiting
Pretoria, South Africa, 0001
Spain
Recruiting
Barcelona, Spain, 08003
Active, not recruiting
Barcelona, Spain, 08035
Active, not recruiting
Barcelona, Spain, 08036
Recruiting
Barcelona, Spain, 08916
Recruiting
Barcelona, Spain, 08025
Active, not recruiting
Castellon, Spain, 12002
Recruiting
Cordoba, Spain, 14004
Active, not recruiting
Elche, Spain, 03203
Active, not recruiting
Huelva, Spain, 21005
Active, not recruiting
Jaen, Spain, 23007
Recruiting
La Coruna, Spain, 15009
Active, not recruiting
La Coruna, Spain, 15006
Active, not recruiting
La Laguna, Spain, 38320
Active, not recruiting
Lleida, Spain, 25198
Active, not recruiting
Madrid, Spain, 28040
Active, not recruiting
Madrid, Spain, 28034
Active, not recruiting
Madrid, Spain, 28050
Active, not recruiting
Madrid, Spain, 28033
Active, not recruiting
Madrid, Spain, 28041
Recruiting
Murcia, Spain, 30008
Active, not recruiting
Málaga, Spain, 29010
Recruiting
Palma de Mallorca, Spain, 07198
Active, not recruiting
Palma de Mallorca, Spain, 07014
Recruiting
Sabadell, Spain, 08208
Active, not recruiting
Salamanca, Spain, 37007
Active, not recruiting
San Sebastian, Spain, 20012
Active, not recruiting
San Sebastian, Spain, 20080
Recruiting
Santander, Spain, 39008
Active, not recruiting
Santiago de Compostela, Spain, 15706
Active, not recruiting
Sevilla, Spain, 41013
Active, not recruiting
Sevilla, Spain, 41009
Recruiting
Sevilla, Spain, 41014
Active, not recruiting
Toledo, Spain, 45004
Active, not recruiting
Valencia, Spain, 46009
Active, not recruiting
Valencia, Spain, 46015
Active, not recruiting
Valencia, Spain, 46010
Recruiting
Zaragoza, Spain, 50009
Sweden
Recruiting
Göteborg, Sweden, 41345
Active, not recruiting
Linkoeping, Sweden, 58185
Recruiting
Stockholm, Sweden, S-118 83
Active, not recruiting
Umea, Sweden, 90185
Recruiting
Uppsala, Sweden, 75185
Switzerland
Active, not recruiting
Basel, Switzerland, 4031
Active, not recruiting
Genève 14, Switzerland, 1211
Active, not recruiting
Luzern, Switzerland, 6004
Active, not recruiting
St. Gallen, Switzerland, 9007
Active, not recruiting
Zürich, Switzerland, 8008
Taiwan
Active, not recruiting
Changhua, Taiwan, 500
Recruiting
Kaohsiung, Taiwan, 807
Active, not recruiting
Taichung, Taiwan, 407
Recruiting
Tainan, Taiwan, 704
Active, not recruiting
Taipei, Taiwan, 114
Active, not recruiting
Taipei, Taiwan, 00112
Active, not recruiting
Taipei, Taiwan, 100
Thailand
Active, not recruiting
Chiang Rai, Thailand, 57000
Active, not recruiting
Lopburi, Thailand, 15000
Recruiting
Phitsanulok, Thailand, 65000
Active, not recruiting
Songkla, Thailand, 90110
Recruiting
Surat Thani, Thailand, 84000
Ukraine
Active, not recruiting
Cherkassy, Ukraine, 18009
Active, not recruiting
Dnipropetrovsk, Ukraine, 43102
Active, not recruiting
Ivano-frankivsk, Ukraine, 76018
Active, not recruiting
Kiev, Ukraine, 03115
Recruiting
Lutsk, Ukraine, 43018
Active, not recruiting
Lvov, Ukraine, 79031
Not yet recruiting
Odesa, Ukraine, 65055
Active, not recruiting
Ternopil, Ukraine, 46023
United Kingdom
Recruiting
Berkshire, United Kingdom, RG1 5AN
Active, not recruiting
Cardiff, United Kingdom, CF14 2TL
Active, not recruiting
Cheltenham, United Kingdom, GL53 7AN
Recruiting
Colchester, United Kingdom, CO3 3NB
Active, not recruiting
Coventry, United Kingdom, CV2 2DX
Active, not recruiting
Edinburgh, United Kingdom, EH4 2XU
Active, not recruiting
Exeter, United Kingdom, EX2 5DW
Recruiting
Ipswich, United Kingdom, IP4 5PD
Recruiting
Leeds, United Kingdom, LS9 7TF
Active, not recruiting
London, United Kingdom, SW3 6JJ
Recruiting
London, United Kingdom, N6A 4L6
Active, not recruiting
London, United Kingdom, EC1 A7BE
Active, not recruiting
London, United Kingdom, NW1 2PG
Recruiting
Manchester, United Kingdom, M20 4BX
Active, not recruiting
Merseyside, United Kingdom, CH63 45Y
Active, not recruiting
Northwood, United Kingdom, HA6 2RN
Active, not recruiting
Nottingham, United Kingdom, NG5 1PB
Recruiting
Oxford, United Kingdom, OX3 7LJ
Active, not recruiting
Peterborough, United Kingdom, PE3 9GZ
Active, not recruiting
Portsmouth, United Kingdom, PO6 3LY
Active, not recruiting
Preston, United Kingdom, PR2 9HT
Active, not recruiting
Sheffield, United Kingdom, S1O 2SJ
Active, not recruiting
Stoke-on-trent, United Kingdom, ST4 7LN
Active, not recruiting
Sutton, United Kingdom, SM2 5PT
Active, not recruiting
Truro, United Kingdom, TR1 3LJ
Active, not recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Breast International Group
Genentech
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01358877     History of Changes
Other Study ID Numbers: BO25126, 2010-022902-41, BIG 04-11, TOC4939G
Study First Received: May 20, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013