Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Conditions
HER2-positive Carcinoma of Breast
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Trastuzumab
Type: Drug
Overall Status
Recruiting
Summary
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Patient who has histologically confirmed and newly diagnosed breast cancer

- 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 bilateral breast cancer

- 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.
Locations
Buenos Aires, Argentina
Status: Not yet recruiting
Córdoba, Argentina
Status: Not yet recruiting
Quilmes, Argentina
Status: Not yet recruiting
Rosario, Argentina
Status: Not yet recruiting
Rosario, Argentina
Status: Active, not recruiting
San Miguel De Tucumán, Argentina
Status: Active, not recruiting
San Salvador De Jujuy, Argentina
Status: Active, not recruiting
Santa Fe, Argentina
Status: Active, not recruiting
Santa Rosa, Argentina
Status: Active, not recruiting
Brest, Belarus
Status: Active, not recruiting
Minsk, Belarus
Status: Recruiting
Minsk, Belarus
Status: Recruiting
Sarajevo, Bosnia and Herzegovina
Status: Not yet recruiting
Tuzla, Bosnia and Herzegovina
Status: Not yet recruiting
Barretos, Brazil
Status: Not yet recruiting
Brasilia, Brazil
Status: Not yet recruiting
Caxias Do Sul, Brazil
Status: Not yet recruiting
Curitiba, Brazil
Status: Not yet recruiting
Goiânia, Brazil
Status: Not yet recruiting
Ijuí, Brazil
Status: Not yet recruiting
Jaú, Brazil
Status: Not yet recruiting
Joaçaba, Brazil
Status: Not yet recruiting
Lajeado, Brazil
Status: Not yet recruiting
Natal, Brazil
Status: Not yet recruiting
Porto Alegre, Brazil
Status: Not yet recruiting
Porto Alegre, Brazil
Status: Not yet recruiting
Porto Alegre, Brazil
Status: Not yet recruiting
Recife, Brazil
Status: Not yet recruiting
Ribeirão Preto, Brazil
Status: Not yet recruiting
Sorocaba, Brazil
Status: Not yet recruiting
São Paulo, Brazil
Status: Not yet recruiting
São Paulo, Brazil
Status: Not yet recruiting
São Paulo, Brazil
Status: Not yet recruiting
São Paulo, Brazil
Status: Not yet recruiting
Santiago, Chile
Status: Recruiting
Temuco, Chile
Status: Recruiting
Osijek, Croatia
Status: Active, not recruiting
Pula, Croatia
Status: Active, not recruiting
Guayaquil, Ecuador
Status: Not yet recruiting
Guayaquil, Ecuador
Status: Not yet recruiting
Machala, Ecuador
Status: Not yet recruiting
Quito, Ecuador
Status: Not yet recruiting
Nancy, France
Status: Active, not recruiting
Tbilisi, Georgia
Status: Recruiting
Tbilisi, Georgia
Status: Recruiting
Tbilisi, Georgia
Status: Recruiting
Tbilisi, Georgia
Status: Recruiting
Tbilisi, Georgia
Status: Recruiting
Athens, Greece
Status: Active, not recruiting
Larissa, Greece
Status: Active, not recruiting
Budapest, Hungary
Status: Recruiting
Debrecen, Hungary
Status: Active, not recruiting
Szolnok, Hungary
Status: Not yet recruiting
Bangalore, India
Status: Active, not recruiting
Chennai, India
Status: Recruiting
Chennai, India
Status: Active, not recruiting
Delhi, India
Status: Not yet recruiting
Jaipur, India
Status: Active, not recruiting
Kolkata, India
Status: Active, not recruiting
Kolkata, India
Status: Active, not recruiting
Mumbai, India
Status: Not yet recruiting
Nashik, India
Status: Recruiting
Nashik, India
Status: Recruiting
New Delhi, India
Status: Not yet recruiting
Pune, India
Status: Recruiting
Bari, Italy
Status: Recruiting
Pavia, Italy
Status: Active, not recruiting
Piacenza, Italy
Status: Active, not recruiting
Rimini, Italy
Status: Recruiting
Daugavpils, Latvia
Status: Recruiting
Riga, Latvia
Status: Recruiting
Acapulco, Mexico
Status: Not yet recruiting
Ciudad De México, Mexico
Status: Not yet recruiting
Monterrey, Mexico
Status: Not yet recruiting
Monterrey, Mexico
Status: Not yet recruiting
Arequipa, Peru
Status: Active, not recruiting
Arequipa, Peru
Status: Active, not recruiting
Lima, Peru
Status: Active, not recruiting
Trujillo, Peru
Status: Active, not recruiting
Cebu, Philippines
Status: Recruiting
Makati, Philippines
Status: Recruiting
Manila, Philippines
Status: Not yet recruiting
Pasay, Philippines
Status: Active, not recruiting
Pasig, Philippines
Status: Recruiting
Quezon City, Philippines
Status: Recruiting
San Juan City, Philippines
Status: Recruiting
Taguig, Philippines
Status: Recruiting
Gdansk, Poland
Status: Recruiting
Lodz, Poland
Status: Recruiting
Poznan, Poland
Status: Active, not recruiting
Waszawa, Poland
Status: Recruiting
Lisbon, Portugal
Status: Active, not recruiting
Porto, Portugal
Status: Active, not recruiting
Santa Maria Da Feira, Portugal
Status: Active, not recruiting
Brasov, Romania
Status: Recruiting
Bucharest, Romania
Status: Recruiting
Bucharest, Romania
Status: Active, not recruiting
Cluj-Napoca, Romania
Status: Recruiting
Cluj-Napoca, Romania
Status: Recruiting
Suceava, Romania
Status: Not yet recruiting
Arkhangelsk, Russian Federation
Status: Recruiting
Kazan, Russian Federation
Status: Recruiting
Krasnoyarsk, Russian Federation
Status: Recruiting
Kursk, Russian Federation
Status: Recruiting
Moscow, Russian Federation
Status: Recruiting
Moscow, Russian Federation
Status: Recruiting
Nizhny Novgorod, Russian Federation
Status: Active, not recruiting
Novosibirsk, Russian Federation
Status: Active, not recruiting
Obninsk, Russian Federation
Status: Recruiting
Omsk, Russian Federation
Status: Active, not recruiting
Samara, Russian Federation
Status: Recruiting
Saransk, Russian Federation
Status: Recruiting
St. Petersburg, Russian Federation
Status: Recruiting
St. Petersburg, Russian Federation
Status: Recruiting
St. Petersburg, Russian Federation
Status: Recruiting
St. Petersburg, Russian Federation
Status: Recruiting
Kragujevac, Serbia
Status: Recruiting
Cape Town, South Africa
Status: Active, not recruiting
George, South Africa
Status: Not yet recruiting
Johannesburg, South Africa
Status: Active, not recruiting
Johannesburg, South Africa
Status: Recruiting
Johannesburg, South Africa
Status: Recruiting
Port Elizabeth, South Africa
Status: Active, not recruiting
Pretoria, South Africa
Status: Active, not recruiting
Barcelona, Spain
Status: Active, not recruiting
Sevilla, Spain
Status: Active, not recruiting
Torrevieja, Spain
Status: Active, not recruiting
Zaragoza, Spain
Status: Recruiting
Kaohsiung, Taiwan
Status: Active, not recruiting
Taichung City, Taiwan
Status: Recruiting
Tainan City, Taiwan
Status: Active, not recruiting
Taipei, Taiwan
Status: Active, not recruiting
Taipei, Taiwan
Status: Active, not recruiting
Bangkok, Thailand
Status: Not yet recruiting
Bangkok, Thailand
Status: Not yet recruiting
Adana, Turkey
Status: Not yet recruiting
Ankara, Turkey
Status: Not yet recruiting
Ankara, Turkey
Status: Not yet recruiting
Gaziantep, Turkey
Status: Not yet recruiting
Cherkasy, Ukraine
Status: Active, not recruiting
Donetsk, Ukraine
Status: Not yet recruiting
Kharkiv, Ukraine
Status: Recruiting
Kherson, Ukraine
Status: Recruiting
Khmelnytskyi, Ukraine
Status: Recruiting
Poltava, Ukraine
Status: Recruiting
Sumy, Ukraine
Status: Active, not recruiting
Uzhhorod, Ukraine
Status: Recruiting
Vinnytsya, Ukraine
Status: Recruiting
Zaporizhzhia, Ukraine
Status: Recruiting
Start Date
June 2014
Completion Date
June 2019
Sponsors
Celltrion
Source
Celltrion
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page