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. (see Contacts and Locations)
Verified May 2015 by Hoffmann-La Roche
Sponsor:
Collaborators:
Genentech, Inc.
Breast International Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358877
First received: May 20, 2011
Last updated: May 11, 2015
Last verified: May 2015
  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: Chemotherapy
Drug: pertuzumab
Drug: placebo
Drug: trastuzumab [Herceptin]
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: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Chemotherapy
6-8 cycles of standard chemotherapy (non-anthracycline based or anthracycline-based)
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
Placebo Comparator: 2 Drug: Chemotherapy
6-8 cycles of standard chemotherapy (non-anthracycline based or anthracycline-based)
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

  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
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: NCT01358877

Contacts
Contact: Reference Study ID Number: BO25126 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Arizona
Terminated
Scottsdale, Arizona, United States, 85025
Active, not recruiting
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Terminated
Jonesboro, Arkansas, United States, 72401
United States, California
Active, not recruiting
Everett, California, United States, 98208
Active, not recruiting
Greenbrae, California, United States, 94904
Completed
Hayward, California, United States, 94545
Active, not recruiting
La Jolla, California, United States, 92093
Active, not recruiting
Los Angeles, California, United States, 90048
Active, not recruiting
Oakland, California, United States, 94611
Active, not recruiting
Roseville, California, United States, 95661
Active, not recruiting
Sacramento, California, United States, 95816
Active, not recruiting
Sacramento, California, United States, 95825
Active, not recruiting
San Diego, California, United States, 92108
Terminated
San Francisco, California, United States, 94115
Active, not recruiting
San Francisco, California, United States, 94115
Active, not recruiting
San Jose, California, United States, 95119
Active, not recruiting
Santa Clara, California, United States, 95051
Active, not recruiting
South San Francisco, California, United States, 94080
Active, not 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
Active, not recruiting
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Active, not recruiting
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Active, not recruiting
Washington, District of Columbia, United States, 20016-1468
Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Active, not recruiting
Fort Myers, Florida, United States, 33916
Active, not recruiting
Hollywood, Florida, United States, 33021
Active, not recruiting
Jacksonville, Florida, United States, 32256
Active, not recruiting
Jacksonville, Florida, United States, 32224
Terminated
Lakeland, Florida, United States, 33804-1057
Active, not recruiting
Ocala, Florida, United States, 34471
Active, not recruiting
Pembroke Pines, Florida, United States, 33028-1006
Completed
Port Saint Lucie, Florida, United States, 34952
Active, not recruiting
St Petersburg, Florida, United States, 33719
Active, not recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
Active, not recruiting
Albany, Georgia, United States, 31701
Active, not recruiting
Atlanta, Georgia, United States, 30341
Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Idaho
Active, not recruiting
Post Falls, Idaho, United States, 83854
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60612
Active, not recruiting
Chicago, Illinois, United States, 60637
Terminated
Decatur, Illinois, United States, 62526
Active, not recruiting
Harvey, Illinois, United States, 60426
Active, not recruiting
Maywood, Illinois, United States, 60153
Active, not recruiting
Naperville, Illinois, United States, 60540
Active, not recruiting
Peoria, Illinois, United States, 61615
Active, not recruiting
Plainfield, Illinois, United States, 60585
Active, not recruiting
Quincy, Illinois, United States, 62301
Active, not recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Active, not recruiting
Iowa City, Iowa, United States, 52242
Terminated
Sioux City, Iowa, United States, 51101
United States, Kansas
Active, not recruiting
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Active, not recruiting
Lafayette, Louisiana, United States, 70503
United States, Maine
Active, not recruiting
Brewer, Maine, United States, 04412
Active, not recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Active, not recruiting
Baltimore, Maryland, United States, 21202
Terminated
Baltimore, Maryland, United States, 21201
Active, not recruiting
Baltimore, Maryland, United States, 21237
Active, not recruiting
Bethesda, Maryland, United States, 20817
Terminated
Kensignton, Maryland, United States, 20895
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States, 02215
Active, not recruiting
Boston, Massachusetts, United States, 02118
Active, not recruiting
Boston, Massachusetts, United States, 02114
Completed
Boston, Massachusetts, United States, 02130
United States, Michigan
Active, not recruiting
Grand Rapids, Michigan, United States, 49503
Active, not recruiting
Kalamazoo, Michigan, United States, 49007
Terminated
Traverse City, Michigan, United States, 49614
United States, Minnesota
Active, not recruiting
Edina, Minnesota, United States, 55414
Terminated
Rochester, Minnesota, United States, 55905
Active, not recruiting
Saint Louis Park, Minnesota, United States, 55416
Active, not recruiting
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Active, not recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Active, not recruiting
Columbia, Missouri, United States, 65203
Active, not recruiting
St. Louis, Missouri, United States, 63110
Active, not recruiting
St. Louis, Missouri, United States, 63131
United States, Montana
Terminated
Billings, Montana, United States, 59101
United States, Nebraska
Active, not recruiting
Lincoln, Nebraska, United States, 68510
Active, not recruiting
Omaha, Nebraska, United States, 68106
United States, New Hampshire
Active, not 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
Active, not recruiting
Bronx, New York, United States, 10467
Active, not recruiting
Buffalo, New York, United States, 14263
Terminated
Commack, New York, United States, 11725
Active, not recruiting
New York, New York, United States, 10011
Active, not recruiting
New York, New York, United States, 10065
Active, not recruiting
New York, New York, United States, 10019
Active, not recruiting
New York, New York, United States, 10003
Terminated
Rockville Centre, New York, United States, 11570
Terminated
Sleepy Hollow, New York, United States, 10591
Active, not recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Active, not recruiting
Chapel HIll, North Carolina, United States, 27599
Active, not 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
Active, not recruiting
Cincinnati, Ohio, United States, 45242
Active, not recruiting
Columbus, Ohio, United States, 43219
Active, not recruiting
Dayton, Ohio, United States, 45420
Active, not recruiting
Toledo, Ohio, United States, 43623
United States, Oregon
Active, not recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19141
Active, not 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
Active, not recruiting
Charleston, South Carolina, United States, 29406
Active, not recruiting
Charleston, South Carolina, United States, 29414
Active, not recruiting
Columbia, South Carolina, United States, 29210
Active, not recruiting
Greenville, South Carolina, United States, 29615
United States, South Dakota
Active, not recruiting
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Active, not recruiting
Bristol, Tennessee, United States, 37620
Active, not recruiting
Chattanooga, Tennessee, United States, 37404
Terminated
Kingsport, Tennessee, United States, 37660
Active, not recruiting
Nashville, Tennessee, United States, 37204
Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Active, not recruiting
Dallas, Texas, United States, 75230
Terminated
Dallas, Texas, United States, 75390-8852
Active, not recruiting
Dallas, Texas, United States, 75231
Active, not recruiting
Dallas, Texas, United States, 75246
Active, not recruiting
El Paso, Texas, United States, 79902
Terminated
Fort Worth, Texas, United States, 76177
Active, not recruiting
Fort Worth, Texas, United States, 76104
Completed
Garland, Texas, United States, 77060
Terminated
Houston, Texas, United States, 77030
Active, not recruiting
Houston, Texas, United States, 77024
Active, not recruiting
New Braunfels, Texas, United States, 78130
Active, not recruiting
Plano, Texas, United States, 75075-7787
Terminated
The Woodlands, Texas, United States, 77380
Active, not recruiting
Tyler, Texas, United States, 75702
United States, Utah
Active, not recruiting
Ogden, Utah, United States, 84403
United States, Virginia
Active, not recruiting
Richmond, Virginia, United States, 23230
United States, Washington
Active, not recruiting
Walla Walla, Washington, United States, 99362
United States, West Virginia
Active, not recruiting
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
Active, not recruiting
Green Bay, Wisconsin, United States, 54301
Terminated
Green Bay, Wisconsin, United States, 54311
Active, not recruiting
Marshfield, Wisconsin, United States, 54449
Argentina
Terminated
Buenos Aires, Argentina, 1185
Terminated
Florencio Varela, Argentina, B1878DVB
Terminated
Rosario, Argentina, S2000KZE
Active, not recruiting
San Miguel de Tucuman, Argentina, T4000IAK
Completed
Santa Fe, Argentina, 03000
Australia, New South Wales
Active, not recruiting
Lismore, New South Wales, Australia, 2480
Active, not recruiting
Sydney, New South Wales, Australia, 2060
Active, not recruiting
Waratah, New South Wales, Australia, 2298
Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Active, not recruiting
Auchenflower, Queensland, Australia, 4066
Active, not recruiting
Brisbane, Queensland, Australia, 4101
Australia, South Australia
Active, not recruiting
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Active, not recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Active, not recruiting
East Bentleigh, Victoria, Australia, VIC 3165
Active, not recruiting
Geelong, Victoria, Australia, 3220
Active, not recruiting
Heidelberg, Victoria, Australia, 3084
Active, not recruiting
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Active, not recruiting
Perth, Western Australia, Australia, 6009
Austria
Active, not recruiting
Graz, Austria, 8036
Active, not recruiting
Innsbruck, Austria, 6020
Active, not recruiting
Linz, Austria, 4010
Active, not recruiting
Rankweil, Austria, 6830
Active, not recruiting
Salzburg, Austria, 5020
Active, not 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
Active, not recruiting
Wien, Austria, 1090
Belgium
Active, not recruiting
Bruxelles, Belgium, 1000
Active, not recruiting
Charleroi, Belgium, B6000
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
Active, not recruiting
Namur, Belgium, 5000
Active, not recruiting
Wilrijk, Belgium, 2610
Bulgaria
Active, not recruiting
Sofia, Bulgaria, 1756
Active, not recruiting
Sofia, Bulgaria, 1527
Active, not recruiting
Varna, Bulgaria, 9010
Canada, Alberta
Active, not recruiting
Calgary, Alberta, Canada, T2N 4N2
Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Active, not recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Active, not recruiting
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
Active, not recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Completed
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Active, not recruiting
Hamilton, Ontario, Canada, L8V 5C2
Active, not recruiting
Kingston, Ontario, Canada, K7L 5P9
Active, not recruiting
Mississauga, Ontario, Canada, L5M 2N1
Active, not recruiting
Newmarket, Ontario, Canada, L3Y 2R2
Active, not recruiting
Ottawa, Ontario, Canada, K1H 1C4
Active, not recruiting
St. Catharines, Ontario, Canada, L2R 7C6
Active, not recruiting
Sudbury, Ontario, Canada, P3E 5J1
Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Active, not recruiting
Toronto, Ontario, Canada, M5G 1Z5
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada, H4J 1C5
Completed
Montreal, Quebec, Canada, H2L 4M1
Active, not recruiting
Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Active, not recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Canada
Active, not recruiting
Quebec, Canada, G1S 4L8
Chile
Active, not recruiting
Santiago, Chile, 7501088
Terminated
Santiago, Chile, 7501239
Active, not recruiting
Santiago, Chile, Providencia
Terminated
Santiago, Chile, 8380000
China
Active, not recruiting
Beijing, China, 100021
Active, not recruiting
Beijing, China, 100071
Active, not recruiting
Changchun, China, 130012
Active, not recruiting
Changchun, China, 130021
Active, not recruiting
Changsha, China, 410006
Active, not recruiting
Chengdu, China, 610072
Active, not recruiting
Fujian, China, 350001
Active, not recruiting
Fuzhou, China, 110016
Active, not recruiting
Guangzhou, China, 510060
Active, not recruiting
Guangzhou, China
Active, not recruiting
Hangzhou, China, 310003
Active, not recruiting
Harbin, China, 150081
Active, not recruiting
Nanchang, China, 330006
Active, not recruiting
Shanghai, China, 200080
Active, not recruiting
Shanghai, China, 200433
Active, not recruiting
Shanghai, China, 200032
Active, not recruiting
Shanghai, China, 200025
Active, not recruiting
Shijiazhuang, China, 050011
Terminated
Suzhou, China, 215004
Active, not recruiting
Wuhan, China, 430022
Active, not recruiting
Wuhan, China, 430030
Active, not recruiting
Wuhan, China, 430079
Colombia
Active, not recruiting
Bogota, Colombia
Active, not recruiting
Medellin-Antioquia, Colombia
Active, not recruiting
Monteria, Colombia
Croatia
Active, not recruiting
Split, Croatia, 21000
Active, not recruiting
Varazdin, Croatia, 42000
Active, not recruiting
Zagreb, Croatia, 10000
Czech Republic
Active, not recruiting
Brno, Czech Republic, 656 53
Active, not recruiting
Hradec Kralove, Czech Republic, 500 05
Active, not recruiting
Olomouc, Czech Republic, 775 20
Active, not 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
Active, not recruiting
Hillerod, Denmark, 3400
Active, not recruiting
København, Denmark, 2100
Active, not recruiting
Naestved, Denmark, 4700
Active, not recruiting
Odense, Denmark, 5000
Active, not recruiting
Roskilde, Denmark, 4000
Active, not recruiting
Vejle, Denmark, 7100
El Salvador
Active, not recruiting
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, 84918
Active, not recruiting
Bordeaux, France, 33300
Active, not recruiting
Bordeaux, France, 33076
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
Active, not recruiting
Limoges, France, 87042
Active, not 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, 75651
Active, not recruiting
Paris, France, 75231
Active, not recruiting
Perigueux, France, 24000
Active, not recruiting
Poitiers, France, 86021
Active, not recruiting
Reims, France, 51057
Active, not recruiting
Reims, France, 51056
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
St Cloud, France, 92210
Active, not recruiting
St Prient En Jarez, France, 42271
Active, not recruiting
Strasbourg, France, 67098
Active, not recruiting
Strasbourg, France, 67010
Active, not recruiting
Toulouse, France, 31059
Active, not recruiting
Toulouse, France, 31076
Active, not recruiting
Vandoeuvre Les Nancy, France, 54511
Active, not recruiting
Villejuif, France, 94800
Germany
Active, not recruiting
Amberg, Germany, 92224
Terminated
Ansbach, Germany, 91522
Active, not recruiting
Bad Nauheim, Germany, 61231
Completed
Bergisch Gladbach, Germany, 51465
Active, not recruiting
Berlin, Germany, 10719
Active, not recruiting
Berlin, Germany, 10367
Active, not recruiting
Berlin, Germany, 13125
Active, not recruiting
Berlin, Germany, 14169
Active, not recruiting
Bielefeld, Germany, 33604
Active, not recruiting
Bonn, Germany, 53127
Active, not recruiting
Braunschweig, Germany, 38100
Active, not recruiting
Bremen, Germany, 28209
Active, not recruiting
Böblingen, Germany, 71032
Active, not recruiting
Chemnitz, Germany, 09116
Active, not 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
Active, not recruiting
Erfurt, Germany, 99085
Active, not recruiting
Erlangen, Germany, 91054
Active, not recruiting
Esslingen, Germany, 73730
Active, not recruiting
Frankfurt, Germany, 60596
Active, not recruiting
Frankfurt, Germany, 65929
Active, not recruiting
Frankfurt am Main, Germany, 60389
Active, not recruiting
Freiburg, Germany, 79110
Active, not recruiting
Fürth, Germany, 90766
Active, not recruiting
Greifswald, Germany, 17475
Active, not recruiting
Halle, Germany, 06120
Active, not recruiting
Hamburg, Germany, 20246
Active, not 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
Active, not recruiting
Homburg/Saar, Germany, 66424
Active, not recruiting
Karlsruhe, Germany, 76135
Active, not recruiting
Kassel, Germany, 34125
Active, not recruiting
Kassel, Germany, 34117
Active, not recruiting
Kiel, Germany, 24105
Active, not recruiting
Koeln, Germany, 50935
Active, not recruiting
Köln, Germany, 50931
Active, not recruiting
Landshut, Germany, 84034
Active, not recruiting
Leipzig, Germany, 04277
Active, not recruiting
Ludwigsfelde, Germany, 14974
Active, not recruiting
Lübeck, Germany, 23538
Active, not recruiting
Mainz, Germany, 55131
Active, not recruiting
Muenchen, Germany, 80637
Active, not recruiting
Mönchengladbach, Germany, 41061
Active, not recruiting
München, Germany, 80337
Active, not recruiting
München, Germany, 81675
Active, not recruiting
Münster, Germany, 48149
Active, not recruiting
Offenbach, Germany, 63069
Active, not recruiting
Oldenburg, Germany, 26133
Active, not recruiting
Ravensburg, Germany, 88212
Active, not 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
Active, not recruiting
Tübingen, Germany, 72076
Active, not recruiting
Ulm, Germany, 89075
Active, not recruiting
Velbert, Germany, 42551
Active, not recruiting
Villingen-Schwenningen, Germany, 78052
Active, not recruiting
Wiesbaden, Germany, 65189
Active, not recruiting
Witten, Germany, 58452
Active, not recruiting
Würzburg, Germany, 97080
Guatemala
Active, not recruiting
Guatemala, Guatemala, 01009
Active, not recruiting
Guatemala City, Guatemala, 01015
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong, 852
Active, not recruiting
Hong Kong, Hong Kong
Hungary
Active, not recruiting
Budapest, Hungary, 1062
Completed
Budapest, Hungary, 1083
Active, not recruiting
Budapest, Hungary, 1122
Active, not recruiting
Debrecen, Hungary, 4032
Active, not recruiting
Gyor, Hungary, 9024
Active, not recruiting
Gyula, Hungary, 5700
Active, not recruiting
Kecskemet, Hungary, 6000
Active, not recruiting
Szeged, Hungary, 6720
Completed
Veszprem, Hungary, 8200
India
Active, not recruiting
Pittsfeild, India, 500029
Ireland
Active, not recruiting
Cork, Ireland
Active, not recruiting
Dublin, Ireland, 7
Active, not recruiting
Dublin, Ireland, 4
Active, not recruiting
Dublin, Ireland, 8
Active, not recruiting
Dublin, Ireland, 9
Active, not recruiting
Galway, Ireland
Active, not recruiting
Limerick, Ireland
Israel
Active, not recruiting
Haifa, Israel, 4959381
Terminated
Jerusalem, Israel, 91120-01
Active, not recruiting
Petach Tikva, Israel, 4941492
Active, not recruiting
Ramat Gan, Israel, 52620-00
Active, not recruiting
Rehovot, Israel, 7610001
Active, not recruiting
Tel Aviv, Israel, 64239-06
Italy
Active, not recruiting
Catanzaro, Calabria, Italy, 88100
Active, not recruiting
Avellino, Campania, Italy, 83100
Active, not recruiting
Napoli, Campania, Italy, 80131
Active, not recruiting
Bologna, Emilia-Romagna, Italy, 40138
Active, not recruiting
Carpi, Emilia-Romagna, Italy, 41012
Active, not recruiting
Reggio Emilia, Emilia-Romagna, Italy, 42100
Active, not recruiting
Aviano, Friuli-Venezia Giulia, Italy, 33081
Active, not recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Active, not recruiting
Viterbo, Lazio, Italy, 01100
Active, not recruiting
Genova, Liguria, Italy, 16132
Active, not recruiting
Genova, Liguria, Italy, 16128
Active, not recruiting
Brescia, Lombardia, Italy, 25123
Terminated
Cremona, Lombardia, Italy, 26100
Active, not recruiting
Lecco, Lombardia, Italy, 23900
Active, not recruiting
Legnago, Lombardia, Italy, 37045
Active, not recruiting
Milano, Lombardia, Italy, 20141
Active, not recruiting
Monza, Lombardia, Italy, 20052
Active, not recruiting
Pavia, Lombardia, Italy, 27100
Active, not recruiting
Rozzano, Lombardia, Italy, 20089
Active, not recruiting
Saronno, Lombardia, Italy, 21047
Active, not recruiting
Fano, Marche, Italy, 61032
Active, not recruiting
Candiolo, Piemonte, Italy, 10060
Active, not recruiting
Brindisi, Puglia, Italy, 72100
Active, not recruiting
Prato, Toscana, Italy, 59100
Active, not recruiting
Bolzano, Trentino-Alto Adige, Italy, 39100
Active, not recruiting
Perugia, Umbria, Italy, 06156
Active, not recruiting
Terni, Umbria, Italy, 05100
Japan
Active, not recruiting
Aichi, Japan, 464-8681
Active, not recruiting
Chiba, Japan, 277-8577
Active, not recruiting
Chiba, Japan, 260-8717
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, 862-8505
Recruiting
Kumamoto, Japan, 862-8655
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, 350-1298
Active, not recruiting
Saitama, Japan, 362-0806
Active, not recruiting
Shizuoka, Japan, 411-8777
Active, not recruiting
Shizuoka, Japan, 420-8527
Active, not recruiting
Tochigi, Japan, 329-0498
Active, not recruiting
Tokyo, Japan, 135-8550
Active, not recruiting
Tokyo, Japan, 160-0023
Active, not recruiting
Tokyo, Japan, 113-8677
Active, not recruiting
Tokyo, Japan, 104-0045
Korea, Republic of
Active, not recruiting
Seongnam-si, Korea, Republic of, 463-707
Active, not recruiting
Seoul, Korea, Republic of, 110-744
Active, not recruiting
Seoul, Korea, Republic of, 136-705
Active, not recruiting
Seoul, Korea, Republic of, 120-752
Active, not recruiting
Seoul, Korea, Republic of, 135-710
Active, not recruiting
Seoul, Korea, Republic of, 130-702
Mexico
Terminated
Acapulco, Mexico, 39670
Active, not recruiting
Aguascalientes, Mexico, 20230
Active, not recruiting
Campeche, Mexico, 24096
Terminated
Chihuahua, Mexico, 31000
Active, not recruiting
Durango, Mexico, 34000
Active, not recruiting
Guadalajara, Mexico, 44670
Active, not recruiting
León, Mexico, 37000
Active, not recruiting
Mexico City, Mexico, 06760
Active, not recruiting
Mexico DF, Mexico, 06726
Active, not recruiting
Monterrey, Mexico, 64710
Active, not recruiting
Monterrey, Mexico, 64020
Active, not recruiting
Oaxaca, Mexico, 68000
Terminated
Obregon, Mexico, 85000
Active, not recruiting
Queretaro, Queretaro, Mexico, 076090
Completed
San Luis Potosi, Mexico, 78218
Netherlands
Active, not recruiting
Alkmaar, Netherlands, 1815 JD
Active, not recruiting
Breda, Netherlands, 4819 EV
Active, not recruiting
Delft, Netherlands, 2625 AD
Active, not recruiting
Maastricht, Netherlands, 6229 HX
Active, not recruiting
Zwolle, Netherlands, 8011 JW
New Zealand
Active, not recruiting
Hamilton, New Zealand, 3240
Active, not recruiting
Palmerston North, New Zealand, 4442
Panama
Active, not recruiting
Panama, Panama, 0834-02723
Active, not recruiting
Panama City, Panama, 32400
Peru
Active, not recruiting
Lima, Peru, 34
Terminated
Lima, Peru, Lima 1
Active, not recruiting
Lima, Peru, Lima 41
Active, not recruiting
Lima, Peru, L27
Terminated
Lima, Peru, 1
Active, not recruiting
Trujillo, Peru, 13011
Philippines
Active, not 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
Active, not recruiting
Bydgoszcz, Poland, 85-796
Active, not recruiting
Gdansk, Poland, 80-952
Active, not recruiting
Opole, Poland, 45-060
Active, not recruiting
Warszawa, Poland, 02-781
Active, not recruiting
Wieliszew, Poland, 05-135
Romania
Active, not recruiting
Bucharest, Romania, 050098
Active, not recruiting
Cluj Napoca, Romania, 400015
Active, not recruiting
Cluj-Napoca, Romania, 400015
Active, not recruiting
Iasi, Romania, 700106
Russian Federation
Active, not recruiting
Kazan, Russian Federation, 420029
Active, not recruiting
Moscow, Russian Federation, 115478
Active, not recruiting
Pyatigorsk, Russian Federation, 357502
Active, not recruiting
Samara, Russian Federation, 443031
Active, not recruiting
Stavropol, Russian Federation, 355045
Active, not recruiting
Tula, Russian Federation, 300053
Slovenia
Active, not 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
Active, not recruiting
Pretoria, South Africa, 0002
Spain
Active, not recruiting
Elche, Alicante, Spain, 03203
Active, not recruiting
Sabadell, Barcelona, Barcelona, Spain, 08208
Active, not recruiting
Santander, Cantabria, Spain, 39008
Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20014
Active, not recruiting
Palma De Mallorca, Islas Baleares, Spain, 07014
Active, not recruiting
Palma de Mallorca, Islas Baleares, Spain, 07198
Active, not recruiting
Santiago de Compostela, La Coruña, Spain, 15706
Active, not recruiting
La Laguna, Tenerife, Spain, 38320
Active, not recruiting
Barcelona, Spain, 08907
Active, not recruiting
Barcelona, Spain, 08036
Active, not recruiting
Barcelona, Spain, 08035
Active, not recruiting
Barcelona, Spain, 08041
Active, not recruiting
Barcelona, Spain, 08003
Active, not recruiting
Barcelona, Spain, 08916
Active, not recruiting
Castellon, Spain, 12002
Active, not recruiting
Cordoba, Spain, 14004
Active, not recruiting
Huelva, Spain, 21005
Active, not recruiting
Jaen, Spain, 23007
Active, not recruiting
La Coruña, Spain, 15006
Active, not recruiting
La Coruña, Spain, 15009
Active, not recruiting
Lerida, Spain, 25198
Active, not recruiting
Madrid, Spain, 28033
Active, not recruiting
Madrid, Spain, 28034
Active, not recruiting
Madrid, Spain, 28040
Active, not recruiting
Madrid, Spain, 28007
Active, not recruiting
Madrid, Spain, 28050
Active, not recruiting
Madrid, Spain, 28041
Active, not recruiting
Malaga, Spain, 29010
Active, not recruiting
Murcia, Spain, 30008
Active, not recruiting
Salamanca, Spain, 37007
Active, not recruiting
Sevilla, Spain, 41009
Active, not recruiting
Sevilla, Spain, 41014
Active, not recruiting
Sevilla, Spain, 41013
Active, not recruiting
Toledo, Spain, 45004
Active, not recruiting
Valencia, Spain, 46009
Active, not recruiting
Valencia, Spain, 46026
Active, not recruiting
Valencia, Spain, 46010
Active, not recruiting
Valencia, Spain, 46015
Active, not recruiting
Zaragoza, Spain, 50009
Sweden
Active, not recruiting
Goteborg, Sweden, 40036
Active, not recruiting
Linkoeping, Sweden, 58185
Active, not recruiting
Stockholm, Sweden, 11883
Active, not recruiting
Umea, Sweden, 90185
Active, not 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
Active, not recruiting
Kaohsiung, Taiwan, 807
Active, not recruiting
Taichung, Taiwan, 407
Active, not recruiting
Tainan, Taiwan, 704
Active, not recruiting
Taipei, Taiwan, 100
Active, not recruiting
Taipei, Taiwan, 114
Active, not recruiting
Taipei, Taiwan, 00112
Thailand
Active, not recruiting
Chiang Rai, Thailand, 57000
Active, not recruiting
Lopburi, Thailand, 15000
Active, not recruiting
Phitsanulok, Thailand, 65000
Active, not recruiting
Songkla, Thailand, 90110
Active, not recruiting
Surat Thani, Thailand, 84000
Ukraine
Active, not recruiting
Cherkassy, Ukraine, 18009
Active, not recruiting
Dnipropetrovsk, Ukraine, 43102
Completed
Ivano-Frankivsk, Ukraine, 76018
Active, not recruiting
Kiev, Ukraine, 03115
Active, not recruiting
Lutsk, Ukraine, 43018
Active, not recruiting
Lvov, Ukraine, 79031
Active, not recruiting
Ternopil, Ukraine, 46023
United Kingdom
Active, not recruiting
Berkshire, United Kingdom, RG1 5AN
Active, not recruiting
Cardiff, United Kingdom, CF14 2TL
Active, not recruiting
Cheltenham, United Kingdom, GL53 7AN
Active, not 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
Active, not recruiting
Ipswich, United Kingdom, IP4 5PD
Active, not recruiting
Leeds, United Kingdom, LS9 7TF
Active, not recruiting
London, United Kingdom, N6A 4L6
Active, not recruiting
London, United Kingdom, SW3 6JJ
Active, not recruiting
London, United Kingdom, NW1 2PG
Active, not recruiting
London, United Kingdom, EC1A 7BE
Active, not recruiting
Manchester, United Kingdom, M20 4BX
Active, not recruiting
Northwood, United Kingdom, HA6 2RN
Active, not recruiting
Nottingham, United Kingdom, NG5 1PB
Active, not 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, S10 2SJ
Active, not recruiting
Stoke-on-Trent, United Kingdom, ST4 6QG
Active, not recruiting
Sutton, United Kingdom, SM2 5PT
Active, not recruiting
Truro, United Kingdom, TR1 3LJ
Active, not recruiting
Wirral, United Kingdom, CH63 4JY
Active, not recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Genentech, Inc.
Breast International Group
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, TOC4939G, 2010-022902-41, BIG 04-11
Study First Received: May 20, 2011
Last Updated: May 11, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2015