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A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

NCT02771795 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 538

Last updated 2024-02-02

Study results available
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Summary

A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

Conditions

  • Breast Neoplasms

Interventions

DRUG

Herceptin (trastuzumab)

Intravenous administration

DRUG

SB3 (proposed trastuzumab biosimilar)

Intravenous administration

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Bulgaria
  • Czechia
  • France
  • Poland
  • Romania
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02771795 on ClinicalTrials.gov