Actively Recruiting
Tolerability and Efficacy of Adjuvant T-DM1 in Patients with HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents.
Led by Regina Elena Cancer Institute · Updated on 2024-09-19
160
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized.
CONDITIONS
Official Title
Tolerability and Efficacy of Adjuvant T-DM1 in Patients with HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of HER2 positive breast cancer
- Presence of invasive residual disease on T or N after neoadjuvant chemotherapy including anti-HER2 agents
- Treatment with T-DM1 in the adjuvant post-neoadjuvant setting, combined with hormone therapy if hormone receptors are positive
- Complementary radiotherapy allowed according to guidelines
- Availability of adequate treatment information with adjuvant T-DM1
- Written informed consent for prospective and, if possible, retrospective patients
You will not qualify if you...
- Concurrent treatment with other biological agents
- Lack of clinical data needed for analysis of study objectives
- History of other malignant cancers
- Contraindications to T-DM1 use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
"Regina Elena" National Cancer Institute
Rome, Rome, Italy, 00144
Actively Recruiting
Research Team
P
Patrizia Vici, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here