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Breast cancer, early stage

1912 - Double-blind, randomized phase III study to compare the efficacy and safety of trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer (EBC)


09 Sep 2017


Breast cancer, early stage


Cytotoxic Therapy;  Breast Cancer


Francisco Esteva


Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362


F.J. Esteva1, Y. Baranau2, V. Baryash2, A. Manikhas3, V. Moiseyenko4, G. Dzagnidze5, E. Zhavrid6, D. Boliukh7, D. Stroyakovskiy8, J. Pikiel9, A. Eniu10, D. Komov11, Z. Zautashvili12, G. Morar-Bolba13, R.K. Li14, I. Lifirenko15, A. Rusyn16, S.J. Lee17, S. Yu18, J. Stebbing19

Author affiliations

  • 1 Medical Oncology, Laura and Isaac Perlmutter Cancer Center New York University Langone Medical Center, 10016 - New York/US
  • 2 Medical Oncology, Minsk City Clinical Oncological Dispensary, 220013 - Minsk/BY
  • 3 Medical Oncology, City Clinical Oncology Dispensary, 198255 - Saint Petersburg/RU
  • 4 Medical Oncology, GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), 197758 - Saint Petersburg/RU
  • 5 Medical Oncology, S.Khechinashvili University Clinic, Ltd., 0177 - Tbilisi/GE
  • 6 Medical Oncology, N.N. Alexandrov Research Institute, 223040 - Minsk/BY
  • 7 Medical Oncology, Vinnytsya Regional Clinical Oncology Dispensary, 21029 - Vinnytsya/UA
  • 8 Medical Oncology, Moscow City Oncology Hospital, 143423 - Moscow/RU
  • 9 Oncology, Copernicus PL Sp. z.o.o. Wojewodzkie Centrum Onkologii, 80-219 - Gdańsk/PL
  • 10 Medical Oncology, Cancer Institute Ion Chiricuta, 400015 - Cluj-Napoca/RO
  • 11 Surgical Oncology, N. N. Blokhin Russian Cancer Research Center, 115478 - Moscow/RU
  • 12 Medical Oncology, Research Institute of Clinical Medicine, 0112 - Tbilisi/GE
  • 13 Medical Oncology, Cancer Institute Ion Chiricuta, 400489 - Cluj-Napoca/RO
  • 14 Medical Oncology, St. Luke's Medical Center, 1102 - Quezon City/PH
  • 15 Medical Oncology, Kursk Regional Clinical Oncology Dispensary, 305524 - Kursk/RU
  • 16 Medical Oncology, Transcarpathian Regional Clinical Oncology Dispensary, 88000 - Uzhgorod/UA
  • 17 Clinical Development, Celltrion, Inc., 22014 - Incheon/KR
  • 18 Clinical Planning, Celltrion, Inc., 22014 - Incheon/KR
  • 19 Cancer Medicine And Medical Oncology, Imperial College, Imperial Healthcare NHS Trust, Charing Cross Hospital, W6 8RF - London/GB


Abstract 1912


CT-P6 is a proposed biosimilar to Reference Trastuzumab (RTZ). This trial (2013-004525-84) evaluated the similarity of CT-P6 and RTZ in efficacy and safety for HER2+ EBC.


549 patients with HER2+ EBC were randomized to receive CT-P6 (n = 271) or RTZ (n = 278) in combination with docetaxel (Cycles 1-4) and 5-fluorouracil, epirubicin and cyclophosphamide (Cycles 5-8). CT-P6 or RTZ was administered at 8 mg/kg (Cycle 1 only) followed by 6 mg/kg every 3 weeks. After surgery, patients received CT-P6 or RTZ monotherapy up to 10 cycles. The primary endpoint was pathological complete response (pCR) rate at surgery. Secondary endpoints were overall response rate (ORR), PK, PD and safety.


The pCR rate was 46.8% in CT-P6 and 50.4% in RTZ. The 95% CIs for the estimate of treatment difference were within the equivalence margin (±0.15) in both PPS and ITT. The proportion of patients with at least 1 SAE was 7.4% in CT-P6 and 11.9% in RTZ over 1-year treatment. 6 patients (3 in CT-P6 and 3 in RTZ) withdrew treatment due to significant LVEF decrease. Infusion related reaction was reported for 11.4% of patients in CT-P6 and 10.4% of patients in RTZ.Table:

152PD Summary of efficacy endpoints

n = 248n = 256n = 271n = 278
pCR (ypT0/is ypN0)
pCR rate46.850.443.547.1
(95% CI)(40.4 – 53.2)(44.1 – 56.7)(37.6 – 49.7)(41.1 – 53.2)
Difference estimate −0.0362−0.0358
(95% CI)(−0.1238 – 0.0516)(−0.1198 – 0.0480)
pCR (ypT0 ypN0)
pCR rate39.941.437.338.8
(95% CI)(33.8 – 46.3)(35.3 – 47.7)(31.5 – 43.3)(33.1 – 44.9)
Difference estimate −0.0149−0.0158
(95% CI)(−0.1022 – 0.0731)(−0.0996 – 0.0685)
ORR (independent review)
(95% CI)(83.6 – 92.0)(85.0 – 92.9)(81.7 – 90.2)(82.5 – 90.8)
Difference estimate −0.0115−0.0070
(95% CI)(−0.0990 – 0.0764)(−0.0911 – 0.0769)


This study demonstrated the equivalence of efficacy between CT-P6 and Reference Trastuzumab in EBC patients. Secondary efficacy endpoints also supported the similarity for two study drugs. CT-P6 was well tolerated with a similar safety profile to that of Reference Trastuzumab through the neoadjuvant and adjuvant period.

Clinical trial identification

EudraCT Number: 2013-004525-84 NCT Number: NCT02162667

Legal entity responsible for the study

Celltrion, Inc.


Celltrion, Inc.


F.J. Esteva: Consulting Role: Celltrion, Inc. G. Dzagnidze: Research funding: Celltrion, Inc., Roche, AstraZeneca Pharmaceutical, Inc. A. Eniu: Research Funding: Roche, AstraZeneca, Celltrion, Inc., Pfizer. Travel, Accommodations, Expenses: Roche, AstraZeneca, Teva. G. Morar-Bolba: Consulting or Advisory Role: Pierre Fabre. Travel, Accodomations, Expenses: Roche. R.K. Li: Research Funding: Pfizer, GlaxoSmithKline, AstraZeneca, Novartis, Celltrion, Inc. S.J. Lee: Employment, Board of Directions, Stock ownership, Travel, Accommodations, Expenses: Celltrion, Inc. S. Yu: Employment, Stock ownership, Travel, Accommodations, Expenses: Celltrion, Inc. J. Stebbing: Consulting or Advisory Role: Celltrion, Inc. All other authors have declared no conflicts of interest.

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