RecruitingNCT06272799

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.

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. Real-world Multicenter Retrospective-prospective Study. ATD-Study.


Sponsor

Regina Elena Cancer Institute

Enrollment

160 participants

Start Date

Sep 20, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is tracking real-world outcomes in women with HER2-positive breast cancer who receive a drug called T-DM1 (trastuzumab emtansine) after surgery, when their pre-surgery chemotherapy did not fully eliminate the tumor. Researchers want to understand how well T-DM1 works and how well it is tolerated in everyday clinical practice. **You may be eligible if...** - You have been diagnosed with HER2-positive breast cancer - You received chemotherapy plus anti-HER2 treatment before surgery, but cancer cells were still found after surgery - You are receiving or have received T-DM1 as follow-up (adjuvant) treatment **You may NOT be eligible if...** - You are receiving other experimental biological treatments at the same time - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGT-DM1 adjuvant

Evaluate the tolerability of treatment with adjuvant T-DM1 after failure to respond complete pathology to neoadjuvant treatment in terms of adverse events


Locations(1)

"Regina Elena" National Cancer Institute

Rome, Rome, Italy

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NCT06272799


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