Clinical trial NCT02162667: Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Official title: Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HER2-positive Carcinoma of Breast
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
Collaborators: name: Nippon Kayaku Co., Ltd.
First posted: 2014-06-13
Enrollment: 562
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)
timeFrame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)
Secondary outcomes:
measure: The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status
timeFrame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)
measure: The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS
timeFrame: After Neo-adjuvant therapy and Surgery (up to 30 weeks)
measure: Overall Response Rate (ORR) From Local Review
timeFrame: After Neo-adjuvant therapy (up to 24 weeks)
measure: Disease-free Survival
timeFrame: Up to 3 years from the day of last patient enrollment (during whole study period)
measure: Progression-Free Survival
timeFrame: Up to 3 years from the day of last patient enrollment (during whole study period)
measure: Overall Survival
timeFrame: Up to 3 years from the day of last patient enrollment (during whole study period)
measure: The Number of Patients Who Had Progressive Disease or Recurrence
timeFrame: Up to 3 years from the day of last patient enrollment (during whole study period)
measure: Maximum Serum Concentration After Administration (Cmax) in Each Cycle
timeFrame: End of each treatment cycles, up to 24 weeks (during neoadjuvant period)
measure: Trough Serum Concentration (Ctrough) in Each Cycle
timeFrame: Pre-infusion of cycles 1 to 8 during neoadjuvant period
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Córdoba
country: Argentina
city: Quilmes
country: Argentina
city: Rosario
country: Argentina
city: San Salvador De Jujuy
country: Argentina
city: Santa Rosa
country: Argentina
city: Brest
country: Belarus
city: Minsk
country: Belarus
city: Minsk
country: Belarus
city: Sarajevo
country: Bosnia and Herzegovina
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Nancy
country: France
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Bangalore
country: India
city: Chennai
country: India
city: Chennai
country: India
city: Delhi
country: India
city: Jaipur
country: India
city: Kolkata
country: India
city: Mumbai
country: India
city: Nashik
country: India
city: Nashik
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Bari
country: Italy
city: Pavia
country: Italy
city: Piacenza
country: Italy
city: Rimini
country: Italy
city: Tokyo
country: Japan
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Acapulco
country: Mexico
city: Monterrey
country: Mexico
city: Arequipa
country: Peru
city: Arequipa
country: Peru
city: Lima
country: Peru
city: Trujillo
country: Peru
city: Cebu
country: Philippines
city: Makati
country: Philippines
city: Manila
country: Philippines
city: Pasig
country: Philippines
city: Quezon City
country: Philippines
city: San Juan City
country: Philippines
city: Taguig
country: Philippines
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Warsaw
country: Poland
city: Lisbon
country: Portugal
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Cluj-Napoca
country: Romania
city: Suceava
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Samara
country: Russian Federation
city: Saransk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Cape Town
country: South Africa
city: George
country: South Africa
city: Johannesburg
country: South Africa
city: Johannesburg
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Sevilla
country: Spain
city: Zaragoza
country: Spain
city: Kaohsiung
country: Taiwan
city: Taichung City
country: Taiwan
city: Taipei
country: Taiwan
city: Cherkasy
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Khmel'nyts'kyy
country: Ukraine
city: Poltava
country: Ukraine
city: Sumy
country: Ukraine
city: Uzhhorod
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.