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 ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
Breast International Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358877
First received: May 20, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (t rastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pert uzumab 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 wee ks. 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 ]

Enrollment: 4808
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

  Hide Study Locations
Locations
United States, Arizona
Scottsdale, Arizona, United States, 85025
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Everett, California, United States, 98208
Greenbrae, California, United States, 94904
Hayward, California, United States, 94545
La Jolla, California, United States, 92093
Los Angeles, California, United States, 90048
Oakland, California, United States, 94611
Roseville, California, United States, 95661
Sacramento, California, United States, 95816
Sacramento, California, United States, 95825
San Diego, California, United States, 92108
San Francisco, California, United States, 94115
San Jose, California, United States, 95119
Santa Clara, California, United States, 95051
South San Francisco, California, United States, 94080
Vallejo, California, United States, 94589
Walnut Creek, California, United States, 94596
United States, Colorado
Denver, Colorado, United States, 80220
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Washington, District of Columbia, United States, 20016-1468
Washington, District of Columbia, United States, 20010
United States, Florida
Fort Myers, Florida, United States, 33916
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32224
Jacksonville, Florida, United States, 32256
Lakeland, Florida, United States, 33804-1057
Ocala, Florida, United States, 34471
Pembroke Pines, Florida, United States, 33028-1006
Port Saint Lucie, Florida, United States, 34952
St Petersburg, Florida, United States, 33719
West Palm Beach, Florida, United States, 33401
United States, Georgia
Albany, Georgia, United States, 31701
Atlanta, Georgia, United States, 30341
Marietta, Georgia, United States, 30060
United States, Idaho
Post Falls, Idaho, United States, 83854
United States, Illinois
Chicago, Illinois, United States, 60637
Chicago, Illinois, United States, 60612
Decatur, Illinois, United States, 62526
Harvey, Illinois, United States, 60426
Maywood, Illinois, United States, 60153
Naperville, Illinois, United States, 60540
Peoria, Illinois, United States, 61615
Plainfield, Illinois, United States, 60585
Quincy, Illinois, United States, 62301
Urbana, Illinois, United States, 61801
United States, Iowa
Iowa City, Iowa, United States, 52242
Sioux City, Iowa, United States, 51101
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Lafayette, Louisiana, United States, 70503
United States, Maine
Brewer, Maine, United States, 04412
Scarborough, Maine, United States, 04074
United States, Maryland
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21202
Baltimore, Maryland, United States, 21237
Bethesda, Maryland, United States, 20817
Kensignton, Maryland, United States, 20895
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Boston, Massachusetts, United States, 02118
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02130
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Grand Rapids, Michigan, United States, 49503
Kalamazoo, Michigan, United States, 49007
Traverse City, Michigan, United States, 49614
United States, Minnesota
Edina, Minnesota, United States, 55414
Rochester, Minnesota, United States, 55905
Saint Louis Park, Minnesota, United States, 55416
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Columbia, Missouri, United States, 65203
St. Louis, Missouri, United States, 63110
St. Louis, Missouri, United States, 63131
United States, Montana
Billings, Montana, United States, 59101
United States, Nebraska
Lincoln, Nebraska, United States, 68510
Omaha, Nebraska, United States, 68106
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
Manchester, New Hampshire, United States, 03102
United States, New Jersey
Basking Ridge, New Jersey, United States, 07920
Livingston, New Jersey, United States, 07039
United States, New York
Albany, New York, United States, 12206
Bronx, New York, United States, 10467
Buffalo, New York, United States, 14263
Commack, New York, United States, 11725
New York, New York, United States, 10065
New York, New York, United States, 10019
New York, New York, United States, 10003
New York, New York, United States, 10011
Rockville Centre, New York, United States, 11570
Sleepy Hollow, New York, United States, 10591
Syracuse, New York, United States, 13210
United States, North Carolina
Chapel HIll, North Carolina, United States, 27599
Hickory, North Carolina, United States, 28602
United States, North Dakota
Fargo, North Dakota, United States, 58122-9988
United States, Ohio
Akron, Ohio, United States, 44304
Cincinnati, Ohio, United States, 45242
Columbus, Ohio, United States, 43219
Dayton, Ohio, United States, 45420
Toledo, Ohio, United States, 43623
United States, Oregon
Portland, Oregon, United States, 97213
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19141
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15213
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Providence, Rhode Island, United States, 02906
Providence, Rhode Island, United States, 02903
United States, South Carolina
Charleston, South Carolina, United States, 29406
Charleston, South Carolina, United States, 29414
Columbia, South Carolina, United States, 29210
Greenville, South Carolina, United States, 29615
United States, South Dakota
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Bristol, Tennessee, United States, 37620
Chattanooga, Tennessee, United States, 37404
Kingsport, Tennessee, United States, 37660
Nashville, Tennessee, United States, 37204
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75390-8852
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75230
El Paso, Texas, United States, 79902
Fort Worth, Texas, United States, 76104
Fort Worth, Texas, United States, 76177
Garland, Texas, United States, 77060
Houston, Texas, United States, 77030
Houston, Texas, United States, 77024
New Braunfels, Texas, United States, 78130
Plano, Texas, United States, 75075-7787
The Woodlands, Texas, United States, 77380
Tyler, Texas, United States, 75702
United States, Utah
Ogden, Utah, United States, 84403
United States, Virginia
Richmond, Virginia, United States, 23230
United States, Washington
Walla Walla, Washington, United States, 99362
United States, West Virginia
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
Green Bay, Wisconsin, United States, 54301
Green Bay, Wisconsin, United States, 54311
Marshfield, Wisconsin, United States, 54449
Argentina
Buenos Aires, Argentina, 1185
Florencio Varela, Argentina, B1878DVB
Rosario, Argentina, S2000KZE
San Miguel de Tucuman, Argentina, T4000IAK
Santa Fe, Argentina, 03000
Australia, New South Wales
Lismore, New South Wales, Australia, 2480
Sydney, New South Wales, Australia, 2060
Waratah, New South Wales, Australia, 2298
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Brisbane, Queensland, Australia, 4101
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
East Bentleigh, Victoria, Australia, VIC 3165
Geelong, Victoria, Australia, 3220
Heidelberg, Victoria, Australia, 3084
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Perth, Western Australia, Australia, 6009
Austria
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4010
Rankweil, Austria, 6830
Salzburg, Austria, 5020
St Veit An Der Glan, Austria, 9300
Vöcklabruck, Austria, 4840
Wels, Austria, 4600
Wien, Austria, 1090
Wien, Austria, 1130
Belgium
Bruxelles, Belgium, 1000
Charleroi, Belgium, B6000
Edegem, Belgium, 2650
Hasselt, Belgium, 3500
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Namur, Belgium, 5000
Wilrijk, Belgium, 2610
Bulgaria
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1756
Varna, Bulgaria, 9010
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
Surrey, British Columbia, Canada, V3V 1Z2
Vancouver, British Columbia, Canada, V5Z 4E6
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
Kingston, Ontario, Canada, K7L 5P9
Mississauga, Ontario, Canada, L5M 2N1
Newmarket, Ontario, Canada, L3Y 2R2
Ottawa, Ontario, Canada, K1H 1C4
St. Catharines, Ontario, Canada, L2R 7C6
Sudbury, Ontario, Canada, P3E 5J1
Toronto, Ontario, Canada, M5G 1Z5
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H4J 1C5
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H1T 2M4
Quebec City, Quebec, Canada, G1J 1Z4
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4T 7T1
Chile
Santiago, Chile, Providencia
Santiago, Chile, 7501239
Santiago, Chile, 7501088
Santiago, Chile, 8380000
China
Beijing, China, 100071
Beijing, China, 100021
Chang Sha, China, 410006
Changchun, China, 130012
Changchun, China, 130021
Chengdu, China, 610072
Fuzhou, China, 110016
Fuzhou, China, 350001
Guangdong Province, China, 510000
Guangzhou, China, 510060
Hangzhou, China, 310003
Harbin, China, 150081
Nanchang, China, 330006
Shanghai, China, 200433
Shanghai, China, 200032
Shanghai, China, 200025
Shanghai, China, 200080
Shijiazhuang, China, 050011
Suzhou, China, 215006
Wuhan, China, 430022
Wuhan, China, 430030
Wuhan, China, 430079
Colombia
Bogota, Colombia
Medellin-Antioquia, Colombia
Monteria, Colombia
Croatia
Split, Croatia, 21000
Varazdin, Croatia, 42000
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 656 53
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 775 20
Pardubice, Czech Republic, 532 03
Denmark
Aalborg, Denmark, 9000
Esbjerg, Denmark, 6700
Herlev, Denmark, 2730
Hillerod, Denmark, 3400
København, Denmark, 2100
Naestved, Denmark, 4700
Odense, Denmark, 5000
Roskilde, Denmark, 4000
Vejle, Denmark, 7100
El Salvador
Salvador, El Salvador, 01101
San Salvador, El Salvador, 01101
France
Amiens, France, 80090
Angers, France, 49933
Arras, France, 62012
Avignon, France, 84918
Bordeaux, France, 33076
Bordeaux, France, 33300
Brest, France, 29200
Caen, France, 14076
Clermont Ferrand, France, 63011
Dechy, France, 59187
Dijon, France, 21034
Grenoble, France, 38000
La Roche Sur Yon, France, 85925
Le Havre, France, 76600
Lille, France, 59020
Limoges, France, 87042
Lyon, France, 69373
Marseille, France, 13273
Montpellier, France, 34298
Nancy, France, 54100
Nice, France, 06189
Nimes, France, 30900
Paris, France, 75651
Paris, France, 75231
Perigueux, France, 24000
Poitiers, France, 86021
Reims, France, 51057
Reims, France, 51056
Rennes, France, 35042
Rouen, France, 76038
Saint Brieuc, France, 22015
Saint Herblain, France, 44805
St Cloud, France, 92210
St Prient En Jarez, France, 42271
Strasbourg, France, 67098
Strasbourg, France, 67010
Toulouse, France, 31076
Toulouse, France, 31059
Vandoeuvre Les Nancy, France, 54511
Villejuif, France, 94800
Germany
Amberg, Germany, 92224
Ansbach, Germany, 91522
Bad Nauheim, Germany, 61231
Bergisch Gladbach, Germany, 51465
Berlin, Germany, 10719
Berlin, Germany, 14169
Berlin, Germany, 10367
Berlin, Germany, 13125
Bielefeld, Germany, 33604
Bonn, Germany, 53127
Braunschweig, Germany, 38100
Bremen, Germany, 28209
Böblingen, Germany, 71032
Chemnitz, Germany, 09116
Deggendorf, Germany, 94469
Dortmund, Germany, 44137
Dresden, Germany, 01307
Düsseldorf, Germany, 40235
Düsseldorf, Germany, 40225
Erfurt, Germany, 99085
Erlangen, Germany, 91054
Esslingen, Germany, 73730
Frankfurt, Germany, 65929
Frankfurt, Germany, 60596
Frankfurt am Main, Germany, 60389
Freiburg, Germany, 79110
Fürth, Germany, 90766
Greifswald, Germany, 17475
Halle, Germany, 06120
Hamburg, Germany, 20246
Hameln, Germany, 31785
Hannover, Germany, 30177
Hannover, Germany, 30559
Heidelberg, Germany, 69120
Hildesheim, Germany, 31134
Homburg/Saar, Germany, 66424
Karlsruhe, Germany, 76135
Kassel, Germany, 34125
Kassel, Germany, 34117
Kiel, Germany, 24105
Koeln, Germany, 50935
Köln, Germany, 50931
Landshut, Germany, 84034
Leipzig, Germany, 04277
Ludwigsfelde, Germany, 14974
Lübeck, Germany, 23538
Mainz, Germany, 55131
Muenchen, Germany, 80637
Mönchengladbach, Germany, 41061
München, Germany, 80337
München, Germany, 81675
Münster, Germany, 48149
Offenbach, Germany, 63069
Oldenburg, Germany, 26133
Ravensburg, Germany, 88212
Recklinghausen, Germany, 45657
Rosenheim, Germany, 83022
Rostock, Germany, 18059
Stade, Germany, 21680
Trier, Germany, 54290
Tübingen, Germany, 72076
Ulm, Germany, 89075
Velbert, Germany, 42551
Villingen-Schwenningen, Germany, 78052
Wiesbaden, Germany, 65189
Witten, Germany, 58452
Würzburg, Germany, 97080
Guatemala
Guatemala, Guatemala, 01009
Guatemala City, Guatemala, 01015
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Hungary
Budapest, Hungary, 1083
Budapest, Hungary, 1062
Budapest, Hungary, 1122
Debrecen, Hungary, 4032
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Kecskemet, Hungary, 6000
Szeged, Hungary, 6701
Veszprem, Hungary, 8200
Ireland
Cork, Ireland
Dublin, Ireland, 4
Dublin, Ireland, 9
Dublin, Ireland, 8
Dublin, Ireland, 7
Galway, Ireland
Limerick, Ireland
Israel
Haifa, Israel, 4959381
Jerusalem, Israel, 91120-01
Petach Tikva, Israel, 4941492
Ramat Gan, Israel, 52620-00
Rehovot, Israel, 7610001
Tel Aviv, Israel, 64239-06
Italy
Catanzaro, Calabria, Italy, 88100
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Carpi, Emilia-Romagna, Italy, 41012
Reggio Emilia, Emilia-Romagna, Italy, 42100
Aviano, Friuli-Venezia Giulia, Italy, 33081
Udine, Friuli-Venezia Giulia, Italy, 33100
Viterbo, Lazio, Italy, 01100
Genova, Liguria, Italy, 16132
Genova, Liguria, Italy, 16128
Brescia, Lombardia, Italy, 25123
Cremona, Lombardia, Italy, 26100
Lecco, Lombardia, Italy, 23900
Legnago, Lombardia, Italy, 37045
Milano, Lombardia, Italy, 20141
Monza, Lombardia, Italy, 20052
Pavia, Lombardia, Italy, 27100
Rozzano, Lombardia, Italy, 20089
Saronno, Lombardia, Italy, 21047
Fano, Marche, Italy, 61032
Candiolo, Piemonte, Italy, 10060
Brindisi, Puglia, Italy, 72100
Prato, Toscana, Italy, 59100
Bolzano, Trentino-Alto Adige, Italy, 39100
Perugia, Umbria, Italy, 06156
Terni, Umbria, Italy, 05100
Japan
Aichi, Japan, 464-8681
Chiba, Japan, 260-8717
Chiba, Japan, 277-8577
Ehime, Japan, 791-0280
Fukuoka, Japan, 811-1395
Gunma, Japan, 371-8511
Hiroshima, Japan, 730-8518
Iwate, Japan, 020-8505
Kagoshima, Japan, 892-0833
Kanagawa, Japan, 216-8511
Kanagawa, Japan, 259-1193
Kumamoto, Japan, 862-8505
Kyoto, Japan, 606-8507
Niigata, Japan, 951-8566
Osaka, Japan, 537-0025
Osaka, Japan, 540-0006
Saitama, Japan, 362-0806
Saitama, Japan, 350-1298
Shizuoka, Japan, 420-8527
Shizuoka, Japan, 411-8777
Tochigi, Japan, 329-0498
Tokyo, Japan, 135-8550
Tokyo, Japan, 113-8677
Tokyo, Japan, 104-0045
Tokyo, Japan, 160-0023
Korea, Republic of
Seongnam-si, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 130-702
Seoul, Korea, Republic of, 110-744
Mexico
Acapulco, Mexico, 39670
Aguascalientes, Mexico, 20230
Campeche, Mexico, 24096
Chihuahua, Mexico, 31000
Durango, Mexico, 34000
Guadalajara, Mexico, 44670
León, Mexico, 37000
Mexico City, Mexico, 06760
Mexico DF, Mexico, 06726
Monterrey, Mexico, 64710
Monterrey, Mexico, 64020
Oaxaca, Mexico, 68000
Obregon, Mexico, 85000
Queretaro, Mexico, 76178
San Luis Potosi, Mexico, 78218
Netherlands
Alkmaar, Netherlands, 1815 JD
Breda, Netherlands, 4819 EV
Delft, Netherlands, 2625 AD
Maastricht, Netherlands, 6229 HX
Zwolle, Netherlands, 8011 JW
New Zealand
Hamilton, New Zealand, 3240
Palmerston North, New Zealand, 4442
Panama
Panama, Panama, 0834-02723
Panama City, Panama, 32400
Peru
Lima, Peru, 1
Lima, Peru, Lima 1
Lima, Peru, 34
Lima, Peru, Lima 41
Lima, Peru, L27
Trujillo, Peru, 13011
Philippines
Manila, Philippines, 1008
Pasig City, Philippines, 1605
Quezon City, Luzon, Philippines, 1101
Poland
Bialystok, Poland, 15-027
Bydgoszcz, Poland, 85-796
Gdansk, Poland, 80-952
Opole, Poland, 45-060
Warszawa, Poland, 02-781
Wieliszew, Poland, 05-135
Romania
Bucharest, Romania, 050098
Cluj Napoca, Romania, 400015
Cluj-Napoca, Romania, 400015
Iasi, Romania, 700106
Russian Federation
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 115478
Pyatigorsk, Russian Federation, 357502
Samara, Russian Federation, 443031
Stavropol, Russian Federation, 355045
Tula, Russian Federation, 300053
Slovenia
Ljubljana, Slovenia, 1000
South Africa
Bloemfontein, South Africa, 9301
Floracliffe, South Africa, 1715
Johannesburg, South Africa, 2193
Pretoria, South Africa, 0002
Spain
Elche, Alicante, Spain, 03203
Sabadell, Barcelona, Barcelona, Spain, 08208
Santander, Cantabria, Spain, 39008
San Sebastian, Guipuzcoa, Spain, 20014
San Sebastian, Guipuzcoa, Spain, 20080
Palma de Mallorca, Islas Baleares, Spain, 07198
Palma De Mallorca, Islas Baleares, Spain, 07014
Santiago de Compostela, La Coruña, Spain, 15706
La Laguna, Tenerife, Spain, 38320
Barcelona, Spain, 08041
Barcelona, Spain, 08907
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08003
Barcelona, Spain, 08916
Castellon, Spain, 12002
Cordoba, Spain, 14004
Huelva, Spain, 21005
Jaen, Spain, 23007
La Coruña, Spain, 15006
La Coruña, Spain, 15009
Lerida, Spain, 25198
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28050
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28033
Malaga, Spain, 29010
Murcia, Spain, 30008
Salamanca, Spain, 37007
Sevilla, Spain, 41014
Sevilla, Spain, 41009
Sevilla, Spain, 41013
Toledo, Spain, 45004
Valencia, Spain, 46009
Valencia, Spain, 46026
Valencia, Spain, 46010
Valencia, Spain, 46015
Zaragoza, Spain, 50009
Sweden
Goteborg, Sweden, 40036
Linkoeping, Sweden, 58185
Stockholm, Sweden, 11883
Umea, Sweden, 90185
Uppsala, Sweden, 75185
Switzerland
Basel, Switzerland, 4031
Genève 14, Switzerland, 1211
Luzern, Switzerland, 6004
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8008
Taiwan
Changhua, Taiwan, 500
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 407
Tainan, Taiwan, 704
Taipei, Taiwan, 114
Taipei, Taiwan, 100
Taipei, Taiwan, 00112
Thailand
Chiang Rai, Thailand, 57000
Lopburi, Thailand, 15000
Phitsanulok, Thailand, 65000
Songkla, Thailand, 90110
Surat Thani, Thailand, 84000
Ukraine
Cherkassy, Ukraine, 18009
Dnipropetrovsk, Ukraine, 43102
Ivano-Frankivsk, Ukraine, 76018
Kiev, Ukraine, 03115
Lutsk, Ukraine, 43018
Lvov, Ukraine, 79031
Ternopil, Ukraine, 46023
United Kingdom
Berkshire, United Kingdom, RG1 5AN
Cardiff, United Kingdom, CF14 2TL
Cheltenham, United Kingdom, GL53 7AN
Colchester, United Kingdom, CO3 3NB
Coventry, United Kingdom, CV2 2DX
Edinburgh, United Kingdom, EH4 2XU
Exeter, United Kingdom, EX2 5DW
Ipswich, United Kingdom, IP4 5PD
Leeds, United Kingdom, LS9 7TF
London, United Kingdom, NW1 2PG
London, United Kingdom, N6A 4L6
London, United Kingdom, SW3 6JJ
London, United Kingdom, EC1A 7BE
Manchester, United Kingdom, M20 4BX
Northwood, United Kingdom, HA6 2RN
Nottingham, United Kingdom, NG5 1PB
Oxford, United Kingdom, OX3 7LJ
Peterborough, United Kingdom, PE3 9GZ
Portsmouth, United Kingdom, PO6 3LY
Preston, United Kingdom, PR2 9HT
Sheffield, United Kingdom, S10 2SJ
Stoke-on-Trent, United Kingdom, ST4 6QG
Sutton, United Kingdom, SM2 5PT
Truro, United Kingdom, TR1 3LJ
Wirral, United Kingdom, CH63 4JY
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Genentech
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: 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
Pertuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014