Breast Cancer Clinical Trial
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
Summary
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (=) 1
Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
HER2-positive breast cancer
Known hormone receptor status of the primary tumor
Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either:
Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory
Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive
No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans
Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required
Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment
Exclusion Criteria:
History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma
History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer
For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)
Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy
History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study
Participants with contraindication to RT while adjuvant RT is clinically indicated
Concurrent anti-cancer treatment in another investigational trial
Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy
Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines
Inadequate hematologic, renal or liver function
Pregnant or lactating women
Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol
Chronic immunosuppressive therapies, including systemic corticosteroids
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There are 288 Locations for this study
Scottsdale Arizona, 85258, United States
Oakland California, 94611, United States
Roseville California, 95661, United States
Sacramento California, 95814, United States
Sacramento California, 95817, United States
San Diego California, 92108, United States
San Jose California, 95119, United States
San Leandro California, 94577, United States
South San Francisco California, 94080, United States
Stanford California, 94305, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Fort Lauderdale Florida, 33308, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33719, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30341, United States
Macon Georgia, 31201, United States
Quincy Illinois, 62301, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Wichita Kansas, 67214, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21202, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Saint Paul Minnesota, 55102, United States
Springfield Missouri, 65807, United States
Lebanon New Hampshire, 03756, United States
New Brunswick New Jersey, 08901, United States
Commack New York, 11725, United States
Lake Success New York, 11042, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27403, United States
Cincinnati Ohio, 45242, United States
Oklahoma City Oklahoma, 73120, United States
Pittsburgh Pennsylvania, 15213, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Bristol Virginia, 24201, United States
Charlottesville Virginia, 22908, United States
Richmond Virginia, 23298, United States
Salem Virginia, 24153, United States
Seattle Washington, 98195, United States
Camperdown New South Wales, 2050, Australia
Waratah New South Wales, 2298, Australia
South Brisbane Queensland, 4101, Australia
Adelaide South Australia, 5056, Australia
Frankston Victoria, 3199, Australia
Heidelberg Victoria, 3084, Australia
Richmond Victoria, 3121, Australia
Murdoch Western Australia, 6150, Australia
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Banja Luka , 78000, Bosnia and Herzegovina
Sarajevo , 7100, Bosnia and Herzegovina
Goiania GO, 74605, Brazil
Porto Alegre RS, 90610, Brazil
Porto Alegre RS, 91350, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Sao Paulo SP, 01308, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 01321, Brazil
Calgary Alberta, T2N 4, Canada
Kelowna British Columbia, V1Y 5, Canada
North Vancouver British Columbia, V7L 2, Canada
Vancouver British Columbia, V5Z 4, Canada
Moncton New Brunswick, E1C 8, Canada
Halifax Nova Scotia, B3H 2, Canada
Kingston Ontario, K7L 2, Canada
London Ontario, N6A 4, Canada
Mississauga Ontario, L5M 2, Canada
Newmarket Ontario, L3Y 2, Canada
Oshawa Ontario, L1G 2, Canada
Sault Ste. Marie Ontario, P6B 0, Canada
Toronto Ontario, M2J 1, Canada
Toronto Ontario, M5G 1, Canada
Windsor Ontario, N8W 2, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H4A 3, Canada
Quebec City Quebec, G1S 4, Canada
Temuco , 48104, Chile
Vina Del Mar , 25205, Chile
Monteria , 23000, Colombia
Brno , 656 5, Czechia
Hradec Kralove , 500 0, Czechia
Pardubice , 532 0, Czechia
Praha 2 , 128 0, Czechia
San Salvador , 01101, El Salvador
Angers , 49000, France
Avignon , 84082, France
Besancon , 25030, France
Bordeaux , 33076, France
Brest , 29609, France
Caen , 14076, France
Clermont Ferrand , 63011, France
Dijon , 21079, France
Le Mans , 72015, France
Lille , 59020, France
Lyon , 69373, France
Nancy , 54100, France
Nice , 06189, France
Nimes , 30029, France
Paris , 75970, France
Plerin , 22190, France
Reims , 51057, France
Rennes , 35042, France
Saint Herblain , 44805, France
St Priest En Jarez , 42271, France
Strasbourg , 67010, France
Strasbourg , 67065, France
Toulouse , 31059, France
Vandoeuvre-les-nancy , 54519, France
Tbilisi , 0159, Georgia
Tbilisi , 0177, Georgia
Tbilisi , 0186, Georgia
Augsburg , 86156, Germany
Bad Nauheim , 61231, Germany
Berlin , 14169, Germany
Bochum , 44787, Germany
Dresden , 01307, Germany
Frankfurt , 60431, Germany
Frankfurt , 65929, Germany
Freiburg , 79110, Germany
Fürth , 90766, Germany
Georgsmarienhütte , 49124, Germany
Hamburg , 20246, Germany
Hannover , 30177, Germany
Hannover , 30625, Germany
Kulmbach , 95326, Germany
Köln , 50679, Germany
Lübeck , 23538, Germany
Meiningen , 98617, Germany
Muenchen , 81377, Germany
Ravensburg , 88212, Germany
Rotenburg/Wümme , 27356, Germany
Stralsund , 18439, Germany
Troisdorf , 53840, Germany
Weinheim , 69469, Germany
Worms , 67550, Germany
Guatemala City , 01015, Guatemala
Guatemala , 01010, Guatemala
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Pokfulam , , Hong Kong
Budapest , 1122, Hungary
Budapest , 1145, Hungary
Debrecen , 4032, Hungary
Szeged , 6720, Hungary
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Roma Lazio, 00128, Italy
Roma Lazio, 00144, Italy
Cremona Lombardia, 26100, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Monza Lombardia, 20900, Italy
Rozzano Lombardia, 20089, Italy
Brindisi Puglia, 72100, Italy
Misterbianco (CT) Sicilia, 95045, Italy
Prato Toscana, 59100, Italy
Terni Umbria, 05100, Italy
Padova Veneto, 35128, Italy
Aichi , 464-8, Japan
Aichi , 467-8, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Gunma , 371-8, Japan
Gunma , 373-8, Japan
Hiroshima , 730-8, Japan
Hiroshima , 734-8, Japan
Hyogo , 663-8, Japan
Iwate , 028-3, Japan
Kagoshima , 892-0, Japan
Kanagawa , 216-8, Japan
Kanagawa , 259-1, Japan
Kumamoto , 862-8, Japan
Kumamoto , 862-8, Japan
Kyoto , 606-8, Japan
Niigata , 951-8, Japan
Okayama , 701-0, Japan
Okinawa , 901-0, Japan
Osaka , 540-0, Japan
Osaka , 541-8, Japan
Saitama , 350-1, Japan
Saitama , 362-0, Japan
Shizuoka , 411-8, Japan
Shizuoka , 420-8, Japan
Tochigi , 329-0, Japan
Tokyo , 104-0, Japan
Tokyo , 104-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Tokyo , 142-8, Japan
Tokyo , 160-0, Japan
Gyeonggi-do , 410-7, Korea, Republic of
Gyeonggi-do , 443-3, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Distrito Federal , 14000, Mexico
León , 37000, Mexico
Mexico City , 03100, Mexico
Monterrey , 64020, Mexico
Oslo , 0450, Norway
Stavanger , 4011, Norway
Panama , 0832, Panama
Lima , Lima , Peru
Lima , Lima , Peru
Lima , Lima , Peru
Miraflores , Lima , Peru
Pasay , 1300, Philippines
Quezon City , 1100, Philippines
Bialystok , 15-02, Poland
Bydgoszcz , 85-79, Poland
Gdansk , 80-21, Poland
Kraków , 30-68, Poland
Lodz , 93-51, Poland
Lublin , 20-09, Poland
Otwock , 05-40, Poland
Warszawa , 02-78, Poland
Bucuresti , 02232, Romania
Cluj Napoca , 40001, Romania
Cluj-Napoca , 40000, Romania
Iasi , 70048, Romania
Ivanovo , 15304, Russian Federation
Kazan , 42002, Russian Federation
Moscow , 11547, Russian Federation
Orenburg , 46002, Russian Federation
Ryazan , 39001, Russian Federation
Saint Petersburg , 19775, Russian Federation
Samara , 44303, Russian Federation
Singapore , 11922, Singapore
Singapore , 16961, Singapore
La Laguna Tenerife, 38320, Spain
Bilbao Vizcaya, 48903, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08907, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Malaga , 29010, Spain
Murcia , 30120, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Göteborg , 413 4, Sweden
Uppsala , 751 8, Sweden
Örebro , 701 8, Sweden
Chur , 7000, Switzerland
Luzern , 6004, Switzerland
Zürich , 8008, Switzerland
Changhua , 500, Taiwan
Kaohsiung , 807, Taiwan
Taichung , 407, Taiwan
Taipei , 00112, Taiwan
Taipei , 100, Taiwan
Taipei , 114, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10700, Thailand
Chiang Rai , 57000, Thailand
Phitsanuok , 65000, Thailand
Dnipropetrovsk , 43102, Ukraine
Lviv , 79031, Ukraine
Cardiff , CF14 , United Kingdom
Cheltenham , GL53 , United Kingdom
Cornwall , TR1 3, United Kingdom
Coventry , CV2 2, United Kingdom
Edinburgh , EH4 2, United Kingdom
Exeter , EX2 5, United Kingdom
Guildford , GU2 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , SW3 6, United Kingdom
London , W6 8R, United Kingdom
Maidstone , ME16 , United Kingdom
Manchester , M20 4, United Kingdom
New Castle Upon Tyne , NE7 7, United Kingdom
Northwood , HA6 2, United Kingdom
Nottingham , NG5 1, United Kingdom
Peterborough , PE3 9, United Kingdom
Portsmouth , PO6 3, United Kingdom
Sheffield , S10 2, United Kingdom
Somerset , TA1 5, United Kingdom
Stoke-on-Trent , ST4 6, United Kingdom
Sutton , SM2 5, United Kingdom
Yeovil , BA21 , United Kingdom
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