Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
NCT ID: NCT02162667
Last Updated: 2022-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
562 participants
INTERVENTIONAL
2014-06-30
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CT-P6
Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Trastuzumab
Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Interventions
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Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition
* Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).
Exclusion Criteria
* Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.
18 Years
FEMALE
No
Sponsors
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Nippon Kayaku Co., Ltd.
INDUSTRY
Celltrion
INDUSTRY
Responsible Party
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Locations
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Suceava, , Romania
Arkhangelsk, , Russia
Kazan', , Russia
Buenos Aires, , Argentina
Córdoba, , Argentina
Quilmes, , Argentina
Rosario, , Argentina
San Salvador de Jujuy, , Argentina
Santa Rosa, , Argentina
Brest, , Belarus
Minsk, , Belarus
Minsk, , Belarus
Sarajevo, , Bosnia and Herzegovina
Santiago, , Chile
Temuco, , Chile
Nancy, , France
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Budapest, , Hungary
Debrecen, , Hungary
Bangalore, , India
Chennai, , India
Chennai, , India
Delhi, , India
Jaipur, , India
Kolkata, , India
Mumbai, , India
Nashik, , India
Nashik, , India
New Delhi, , India
Pune, , India
Bari, , Italy
Pavia, , Italy
Piacenza, , Italy
Rimini, , Italy
Tokyo, , Japan
Daugavpils, , Latvia
Riga, , Latvia
Acapulco, , Mexico
Monterrey, , Mexico
Arequipa, , Peru
Arequipa, , Peru
Lima, , Peru
Trujillo, , Peru
Cebu, , Philippines
City of Taguig, , Philippines
Makati, , Philippines
Manila, , Philippines
Pasig, , Philippines
Quezon City, , Philippines
San Juan City, , Philippines
Gdansk, , Poland
Lodz, , Poland
Warsaw, , Poland
Lisbon, , Portugal
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Cluj-Napoca, , Romania
Krasnoyarsk, , Russia
Kursk, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Obninsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saransk, , Russia
Cape Town, , South Africa
George, , South Africa
Johannesburg, , South Africa
Johannesburg, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Seville, , Spain
Zaragoza, , Spain
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Cherkasy, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Khmelnytskyi, , Ukraine
Poltava, , Ukraine
Sumy, , Ukraine
Uzhhorod, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhia, , Ukraine
Countries
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References
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Stebbing J, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Pikiel J, Eniu AE, Li RK, Tiangco B, Lee SJ, Kim S. Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial. Breast Cancer Res Treat. 2021 Aug;188(3):631-640. doi: 10.1007/s10549-021-06240-5. Epub 2021 Jun 20.
Esteva FJ, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskiy D, Pikiel J, Eniu AE, Li RK, Rusyn AV, Tiangco B, Lee SJ, Lee SY, Yu SY, Stebbing J. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial. Cancer Chemother Pharmacol. 2019 Oct;84(4):839-847. doi: 10.1007/s00280-019-03920-4. Epub 2019 Aug 19.
Stebbing J, Baranau Y, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskii D, Pikiel J, Eniu A, Komov D, Morar-Bolba G, Li RK, Rusyn A, Lee SJ, Lee SY, Esteva FJ. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017 Jul;18(7):917-928. doi: 10.1016/S1470-2045(17)30434-5. Epub 2017 Jun 4.
Other Identifiers
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2013-004525-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CT-P6 3.2
Identifier Type: -
Identifier Source: org_study_id
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