Spots Global Cancer Trial Database for A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
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Trial Identification
Brief Title: A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
Official Title: Multicenter Randomized Double-blind Phase III Clinical Trial Comparing Safety and Efficacy of BCD-022 (CJSC BIOCAD, Russia) Used With Paclitaxel to Herceptin® Used With Paclitaxel in the First-line Treatment of HER2+ Metastatic Breast Cancer Patients
Study ID: NCT01764022
Study Description
Brief Summary: BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes pharmacokinetics assessment.
Detailed Description: The study is based on the hypothesis of equivalence of BCD-022 (trastuzumab by JSC BIOCAD, Russia) in combination with paclitaxel used as the therapy of inoperable or metastatic HER2(+) breast cancer in comparison with Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) in combination with paclitaxel. The objectives of the study is to evaluate efficacy, safety and pharmacokinetics of BCD-022 compared with reference trastuzumab by 1. overall response rate and other efficacy parameters; 2. incidence and severity of adverse events; 3. serum concentration after the first and multiple trastuzumab administration; 4. incidence and concentration of anti-trastuzumab antibodies.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Brest Region Clinical Oncology Dispensary, Brest, , Belarus
Gomel Region Clinical Oncology Dispensary, Gomel, , Belarus
Grodno Regional Hospital, Grodno, , Belarus
Vitebsk State Medical University of Order of Peoples' Friendship, Vitebsk, , Belarus
HCG Bangalore Institute of Oncology, Bangalore, , India
M.S.Ramaiah Memorial Hospital, Bangalore, , India
Narayana Hrudayalaya Hospitals, Bangalore, , India
State Health Institution of Moscow "Moscow City Oncology Hospital #62 of Moscow Board of Health", Stepanovskoye, Moscow Region, Russian Federation
Arkhangelsk District Clinical Oncology Dispensary, Arkhangelsk, , Russian Federation
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways", Chelyabinsk, , Russian Federation
State-financed Health Institution "Chelyabinsk Region Clinical Oncology Dispansary", Chelyabinsk, , Russian Federation
State-financed Health Institution "Republican Clinical Oncology Hospital", Izhevsk, , Russian Federation
Institution of Russian Academy of Medical Sciences "Russian Cancer Research Center named after N.N. Blokhin", Moscow, , Russian Federation
Federal State Institution "Moscow Institute of Cancer Research named after P.A. Hertsen" Ministry of Health of Russian Federation, Moscow, , Russian Federation
Regional State Health Institution "Orlov Oncology Dispansary", Orel, , Russian Federation
State Health Institution "Region Oncology Dispansary", Penza, , Russian Federation
Perm Region Oncology Dispensary, Perm, , Russian Federation
Federal Government Budgetary Institution "Rostov Institute of Cancer Research" of Ministry of Health of Russian Federation, Rostov-on-Don, , Russian Federation
Saint Petersburg City Clinical Oncology Center, Saint Petersburg, , Russian Federation
State-financed Health Institution "Samara Region Clinical Oncology Dispansary", Samara, , Russian Federation
Oncology Dispensary 2, Sochi, , Russian Federation
Military Medical Academy named after S.M. Kirov, St.Petersburg, , Russian Federation
N.N.Petrov Oncology Research Center, St.Petersburg, , Russian Federation
Russian scientific center of radiology and surgery technologies, St.Petersburg, , Russian Federation
State-financed Health Institution "Stavropol Region Clinical Oncology Dispansary", Stavropol, , Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan, Ufa, , Russian Federation
Volgograd District Oncology Dispensary №1, Volgograd, , Russian Federation
Donetsk City Oncology Dispensary, Donetsk, , Ukraine
Donetsk Regional Antitumor Center, Donetsk, , Ukraine
Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
Kryvyi Rih Oncology Dispensary, Kryvyi Rih, , Ukraine
Lviv Regional State Cancer Diagnostics and Treatment Center, Lviv, , Ukraine
City Hospital №2, Makiivka, , Ukraine
Poltava Regional Clinical Oncology Dispensary, Poltava, , Ukraine
Zakarpatskyi Regional Clinical Oncology Center, Uzhhorod, , Ukraine
Vinnytsia Regional Clinical Oncology Dispensary, Vinnytsia, , Ukraine
Contact Details
Name: Roman Ivanov, MD, PhD
Affiliation: Vice-president, R&D
Role: STUDY_CHAIR
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