Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

NCT02162667 | Completed Phase 3 Results DMC

• 2 other identifiers: CT-P6 3.22013-004525-84
• Study Type: interventional
• Target: 562
• Locations: 22 countries
• Sites: 98

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.

Conditions

HER2-positive Carcinoma of Breast

Outcome Measures

Primary Outcomes (1)

• 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)

  Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.

  After Neo-adjuvant therapy and Surgery (up to 30 weeks)

Secondary Outcomes (9)

• The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status

  After Neo-adjuvant therapy and Surgery (up to 30 weeks)

• The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS

  After Neo-adjuvant therapy and Surgery (up to 30 weeks)

• Overall Response Rate (ORR) From Local Review

  After Neo-adjuvant therapy (up to 24 weeks)

• Disease-free Survival

  Up to 3 years from the day of last patient enrollment (during whole study period)

• Progression-Free Survival

  Up to 3 years from the day of last patient enrollment (during whole study period)

Study Arms (2)

CT-P6

EXPERIMENTAL

Drug: Trastuzumab

Trastuzumab

ACTIVE COMPARATOR

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.

Also known as: Herceptin

CT-P6; Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead
• Nippon Kayaku Co., Ltd.: collaborator

Study Sites (98)

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Buenos Aires, 1185, Argentina

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Córdoba, X5006IKK, Argentina

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Quilmes, B1878DVB, Argentina

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Rosario, S2000KDS, Argentina

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San Salvador de Jujuy, 4600, Argentina

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Santa Rosa, 6300, Argentina

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Brest, 224027, Belarus

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Minsk, 220013, Belarus

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Minsk, 223040, Belarus

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Sarajevo, 71000, Bosnia and Herzegovina

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Santiago, 6640166, Chile

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Temuco, 4810469, Chile

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Nancy, 54511, France

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Tbilisi, 0112, Georgia

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Tbilisi, 0144, Georgia

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Tbilisi, 0159, Georgia

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Tbilisi, 0177, Georgia

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Tbilisi, 0186, Georgia

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Budapest, 1083, Hungary

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Debrecen, 4032, Hungary

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Bangalore, 560099, India

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Chennai, 600017, India

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Chennai, 600035, India

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Delhi, 110095, India

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Jaipur, 302017, India

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Kolkata, 700016, India

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Mumbai, 400 012, India

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Nashik, 422004, India

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Nashik, 422005, India

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New Delhi, 110076, India

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Pune, 411001, India

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Bari, 70124, Italy

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Pavia, 27100, Italy

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Piacenza, 29100, Italy

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Rimini, 47900, Italy

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Tokyo, Japan

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Daugavpils, LV-5417, Latvia

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Riga, LV-1079, Latvia

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Acapulco, 39670, Mexico

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Monterrey, 64710, Mexico

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Arequipa, 4020, Peru

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Arequipa, Peru

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Lima, 34, Peru

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Trujillo, Peru

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Cebu, 6000, Philippines

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City of Taguig, 1634, Philippines

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Makati, 1229, Philippines

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Manila, 1008, Philippines

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Pasig, 1600, Philippines

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Quezon City, 1102, Philippines

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San Juan City, 1502, Philippines

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Gdansk, 80219, Poland

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Lodz, 93513, Poland

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Warsaw, 04125, Poland

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Lisbon, 1099023, Portugal

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Brasov, 500152, Romania

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Bucharest, 010976, Romania

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Cluj-Napoca, 400058, Romania

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Suceava, 720237, Romania

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Arkhangelsk, 163045, Russia

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Kazan', 420029, Russia

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Krasnoyarsk, 660133, Russia

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Kursk, 305035, Russia

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Moscow, 115478, Russia

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Moscow, 143423, Russia

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Nizhny Novgorod, 603081, Russia

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Novosibirsk, 630099, Russia

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Obninsk, 249036, Russia

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Omsk, Russia

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Saint Petersburg, 188663, Russia

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Saint Petersburg, 194017, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Samara, 443066, Russia

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Saransk, 430032, Russia

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Cape Town, 7570, South Africa

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George, 6530, South Africa

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Johannesburg, 2193, South Africa

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Johannesburg, 2196, South Africa

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Port Elizabeth, 6045, South Africa

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Pretoria, 0002, South Africa

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Seville, 41071, Spain

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Zaragoza, 50009, Spain

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Kaohsiung City, 807, Taiwan

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Taichung, 40447, Taiwan

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Taipei, 100, Taiwan

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Cherkasy, 18009, Ukraine

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Donetsk, 83092, Ukraine

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Kharkiv, 61070, Ukraine

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Kherson, 73000, Ukraine

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Khmelnytskyi, 29000, Ukraine

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Poltava, 36021, Ukraine

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Sumy, 40022, Ukraine

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Uzhhorod, 88014, Ukraine

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Vinnytsia, 21029, Ukraine

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Zaporizhzhia, 69040, Ukraine

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Related Publications (3)

• 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.

  PMID: 34148205 DERIVED

• 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.

  PMID: 31428820 DERIVED

• 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.

  PMID: 28592386 DERIVED

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Head of Clinical Planning Department
• Organization: Celltrion

contact@celltrion.com

82328505000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: June 1, 2014
• Primary Completion: May 26, 2016
• Study Completion: October 1, 2018
• Last Updated: August 3, 2022
• Results First Posted: October 29, 2019

Record last verified: 2019-10

Locations

ES (2); BO (1); UA (10); HU (2); IN (11); ME (2); PE (4); JP (1); BE (3); IT (4); GE (5); LA (2); RO (6); RU (16); PT (1); PL (3); FR (1); ZA (6); PH (7); AR (6); TW (3); CL (2)