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

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ClinicalTrials.gov Identifier: NCT02162667
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Nippon Kayaku Co., Ltd.
Information provided by (Responsible Party):
Celltrion

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE June 2014
Actual Primary Completion Date May 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
Equivalence to Herceptin as determined by pCR (pathological Complete Response) [ Time Frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Equivalence to Herceptin as determined by pCR (pathological Complete Response) [ Time Frame: After Neo-adjuvant therapy and Surgery (up to 30 weeks) ]
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 biospecimens collected in breast and axilla during a surgery.
Change History Complete list of historical versions of study NCT02162667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Official Title  ICMJE Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HER2-positive Carcinoma of Breast
Intervention  ICMJE Drug: Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Name: Herceptin
Study Arms  ICMJE
  • Experimental: CT-P6
    Intervention: Drug: Trastuzumab
  • Active Comparator: Trastuzumab
    Intervention: Drug: Trastuzumab
Publications * 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. Erratum in: Lancet Oncol. 2017 Aug;18(8):e433. Lancet Oncol. 2017 Sep;18(9):e510.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2015)
562
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
532
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date May 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belarus,   Bosnia and Herzegovina,   Brazil,   Chile,   Ecuador,   France,   Georgia,   Greece,   Hungary,   India,   Italy,   Japan,   Latvia,   Mexico,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine
Removed Location Countries Croatia
 
Administrative Information
NCT Number  ICMJE NCT02162667
Other Study ID Numbers  ICMJE CT-P6 3.2
2013-004525-84 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celltrion
Study Sponsor  ICMJE Celltrion
Collaborators  ICMJE Nippon Kayaku Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Celltrion
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP