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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

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.

Condition or disease Intervention/treatment Phase
HER2-positive Carcinoma of Breast Drug: Trastuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2014
Actual Primary Completion Date : May 26, 2016
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: CT-P6 Drug: Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Name: Herceptin

Active Comparator: Trastuzumab Drug: Trastuzumab
Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Other Name: Herceptin




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162667


  Show 129 Study Locations
Sponsors and Collaborators
Celltrion
Nippon Kayaku Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02162667     History of Changes
Other Study ID Numbers: CT-P6 3.2
2013-004525-84 ( EudraCT Number )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents