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Register:	ClinicalTrials.gov
Last refreshed on:	15 August 2022
Main ID:	NCT02162667
Date of registration:	11/06/2014
Prospective Registration:	No
Primary sponsor:	Celltrion
Public title:	Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Scientific 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
Date of first enrolment:	June 2014
Target sample size:	562
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02162667
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase:	Phase 3

Countries of recruitment
Argentina	Belarus	Bosnia and Herzegovina	Brazil	Chile	Croatia	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

Contacts

Key inclusion & exclusion criteria

Health Condition(s) or Problem(s) studied

Intervention(s)

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	29/10/2019
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02162667

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