Long-term Follow-up Study for Cardiac Safety in the Patients with Breast Cancer Who Have Completed the Main Study

Update Il y a 4 ans
Reference: EUCTR2015-005663-17

Woman Man

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Extract

The primary objective is to observe the incidence of symptomatic congestive heart failure (CHF) NYHA class II,III and IV and asymptomatic LVEF decrease in patients who participated in the SB3-G31-BC Study and treated with SB3 ( proposed trastuzumab biosimilar) or Herceptin® as neoadjuvant and adjuvant treatment.


Inclusion criteria

  • Subjects with primary HER2 positive early or locally advanced breast cancer, who have completed the study treatment of SB3-G31-BC