The Synergism Or Long Duration (SOLD) Study
Phase 1
- Conditions
- breast cancerTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512884-30-00
- Lead Sponsor
- HUS-Yhtymae
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 520
Inclusion Criteria
Woman > 18 years of age, confirmed invasive HER2-positive breast cancer
Exclusion Criteria
Presence of distant metastases, clinically significant cardiac disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To find out whether addition of pertuzumab to an adjuvant regimen containing trastuzumab and chemotherapy improves invasive disease-free survival in patients with HER2-positive early breast cancer;Secondary Objective: To investigate whether adding pertuzumab to the adjuvant treatment regimen improves overall survival;Primary end point(s): Invasive disease-free survival
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall survival; Distant disease-free survival; Left ventricle ejection fractions; Adverse event rate; Quality of life