Peri-operative Trastuzumab study for patients with operable breast cancer patients

Phase 3

• Conditions: Health Condition 1: null- Operable Female Breast Cancer

• Registration Number: CTRI/2013/12/004263
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1100

Inclusion Criteria

Confirmed Breast Cancr Patient

Exclusion Criteria

oBilateral breast cancer

oActive uncontrolled cardiac disease, including cardiomyopathy, CHF (New York Heart Association [NYHA] functional classification of >=3), unstable angina, and myocardial infarction (within 12 months of study entry).

oInadequately controlled hypertension (ie, systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg).

oFamily history of congenital long or short QT syndrome, Brugada syndrome or QT/QTc interval > 0.45 second or known history of QT/QTc prolongation or torsade de pointe (TdP).

oSignificant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohnâ??s disease, malabsorption, or grade >=2 diarrhea of any etiology at baseline).

oWomen who are pregnant, breast-feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified