Breast Cancer Clinical Trial
A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
Summary
This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
Eligibility Criteria
Inclusion Criteria:
Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of the parent study closure if the participant received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first dose of control arm study therapy in the extension study
Participants in the control arm from Study BO21976/TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into study TDM4529g (NCT00781612)
Expectation by the investigator that the participant may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the participant may continue to benefit from control arm treatment as given in study BO21976/TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment
Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the participants and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 5 months after the final dose of atezolizumab (if applicable) or 7 months after the final dose of trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period
Male participants whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period
Exclusion Criteria:
AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
Ongoing SAEs from the parent study
Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of participants from study TDM4688g (NCT00943670) with early disease progression who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0, 4.0 or 5.0, as utilized in the parent study
History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable angina, or history of myocardial infarction within 6 months prior to study entry
Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
Current severe, uncontrolled systemic disease (for example [e.g.] clinically significant cardiovascular, pulmonary, or metabolic disease)
Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
Current pregnancy or lactation
History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's last study drug dose in the parent study
History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
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There are 211 Locations for this study
Duarte California, 91010, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Stanford California, 94305, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Littleton Colorado, 80120, United States
Newark Delaware, 18713, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
Pembroke Pines Florida, 33028, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33607, United States
Marietta Georgia, 30060, United States
Post Falls Idaho, 83854, United States
Maywood Illinois, 60153, United States
Peoria Illinois, 61615, United States
Zion Illinois, 60099, United States
Indianapolis Indiana, 46202, United States
Bettendorf Iowa, 52722, United States
Cedar Rapids Iowa, 52403, United States
Wichita Kansas, 67214, United States
Scarborough Maine, 04074, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55454, United States
Rochester Minnesota, 55905, United States
Jefferson City Missouri, 65101, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Livingston New Jersey, 07039, United States
Lake Success New York, 11042, United States
New York New York, 10016, United States
New York New York, 10065, United States
Westbury New York, 11590, United States
Hickory North Carolina, 28602, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43219, United States
Portland Oregon, 97227, United States
Philadelphia Pennsylvania, 19111, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37232, United States
Bedford Texas, 76022, United States
Dallas Texas, 75231, United States
Houston Texas, 77090, United States
Irving Texas, 75063, United States
Irving Texas, 75063, United States
Plano Texas, 75075, United States
San Antonio Texas, 78229, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98405, United States
Frankston Victoria, 3199, Australia
North Melbourne Victoria, 3051, Australia
Wien , 1100, Austria
Gent , 9000, Belgium
Wilrijk , 2610, Belgium
Salvador, Bahia BA, 40170, Brazil
Belo Horizonte MG, 30150, Brazil
Rio de Janeiro RJ, 20560, Brazil
Porto Alegre RS, 90050, Brazil
Porto Alegre RS, 90430, Brazil
Porto Alegre RS, 90610, Brazil
Porto Alegre RS, 91350, Brazil
Itajai SC, 88301, Brazil
Santo Andre SP, 09060, Brazil
Sao Paulo SP, 01317, Brazil
Plovdiv , 4004, Bulgaria
Sofia , 1756, Bulgaria
Kelowna British Columbia, V1Y 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5B 1, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 0, Canada
Saskatoon Saskatchewan, SK S7, Canada
Quebec , G1S 4, Canada
Santiago , 75009, Chile
Beijing , 10014, China
Changchun , 13002, China
Guangzhou , 51006, China
Hangzhou City , 31002, China
Harbin , 15008, China
Nanjing City , 21002, China
Nanjing City , 21110, China
Shanghai City , 20012, China
Zagreb , 10000, Croatia
Brno , 656 5, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Odense C , 5000, Denmark
Vejle , 7100, Denmark
Caen , 14076, France
Dijon , 21079, France
La Roche Sur Yon , 85925, France
Marseille , 13273, France
Montpellier , 34298, France
Paris , 75020, France
Paris , 75231, France
Saint Herblain , 44805, France
Aschaffenburg , 63739, Germany
Berlin , 13125, Germany
Berlin , 14169, Germany
Essen , 45136, Germany
Köln , 50931, Germany
Muenchen , 80637, Germany
Muenchen , 81377, Germany
Stralsund , 18439, Germany
Würzburg , 97080, Germany
Guatemala City , 01015, Guatemala
Hong Kong , , Hong Kong
Budapest , 1032, Hungary
Budapest , 1125, Hungary
Debrecen , 4032, Hungary
Szombathely , 9700, Hungary
Jerusalem , 91031, Israel
Rehovot , 76100, Israel
Tel Aviv , 64239, Israel
Potenza Basilicata, 85100, Italy
Catanzaro Calabria, 88100, Italy
Napoli Campania, 80131, Italy
Meldola Emilia-Romagna, 47014, Italy
Meldola Emilia-Romagna, 47014, Italy
Parma Emilia-Romagna, 43100, Italy
Aviano (PN) Friuli-Venezia Giulia, 33081, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Candiolo Piemonte, 10060, Italy
Sassari Sardegna, 07100, Italy
Misterbianco (CT) Sicilia, 95045, Italy
Pisa Toscana, 56100, Italy
Prato Toscana, 59100, Italy
Hiroshima , 734-8, Japan
Hyogo , 673-8, Japan
Saitama , 350-1, Japan
Daegu , 702-2, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Mexico Mexico CITY (federal District), 03100, Mexico
Acapulco , 39670, Mexico
D.f. , 14080, Mexico
Oaxaca , 68000, Mexico
Auckland , 1023, New Zealand
Skopje , 1000, North Macedonia
Oslo , 0310, Norway
Panama , 0832, Panama
Lima , 18, Peru
Lima , Lima , Peru
Cebu City , 6000, Philippines
Quezon City , 1101, Philippines
San Juan , 1502, Philippines
Gdansk , , Poland
Kielce , 25-73, Poland
Lublin , 20-09, Poland
Otwock , 05-40, Poland
Poznan , 61-86, Poland
Rybnik , 44-20, Poland
Warszawa , 02-78, Poland
Lisboa , 1500-, Portugal
Porto , 4200-, Portugal
St Petersburg Leningrad, 19775, Russian Federation
Moskva Moskovskaja Oblast, 11547, Russian Federation
Moscow , 14342, Russian Federation
St Petersburg , , Russian Federation
Stavropol , 35504, Russian Federation
UFA , 45005, Russian Federation
Singapore , 11922, Singapore
Ljubljana , 1000, Slovenia
Elche Alicante, 03203, Spain
Jerez de La Frontera Cadiz, 11407, Spain
San Sebastian Guipuzcoa, 20080, Spain
Leganes Madrid, 28911, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08907, Spain
Caceres , 10003, Spain
Lerida , 25198, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Sevilla , 41013, Spain
Zaragoza , 50009, Spain
Eskilstuna , 63188, Sweden
Zürich , 8091, Switzerland
Tainan , 704, Taiwan
Tainan , 736, Taiwan
Taipei City , 11259, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10110, Thailand
Bangkok , 10400, Thailand
Dundee , DD12 , United Kingdom
Edinburgh , EH4 2, United Kingdom
Grimsby , DN33 , United Kingdom
Lancaster , LA1 4, United Kingdom
London , NW3 2, United Kingdom
Manchester , M20 4, United Kingdom
Middlesex , HA6 2, United Kingdom
Northwood , HA6 2, United Kingdom
Nottingham , NG5 1, United Kingdom
Poole , BH15 , United Kingdom
Romford , RM7 0, United Kingdom
Swansea , SA6 6, United Kingdom
Truro , TR1 3, United Kingdom
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