Evaluating T-DM1 treatment in HER2 positive breast cancer patients after chemotherapy
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.
This study is testing how well T-DM1 works and how well patients with HER2 positive breast cancer tolerate it after they have had chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT06272799 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the tolerability and efficacy of T-DM1 in patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant chemotherapy. It will involve a multicenter approach across various oncology centers in Italy, analyzing real-world data from patients treated according to standard clinical practices. The study will include both retrospective and prospective data collection to evaluate treatment outcomes and patient responses.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with HER2 positive breast cancer who have residual invasive disease after neoadjuvant chemotherapy.
Not a fit: Patients with a history of other malignant neoplasms or contraindications to T-DM1 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment options for patients with residual disease after chemotherapy, potentially improving their outcomes.
How similar studies have performed: While this approach is based on real-world data, similar studies evaluating T-DM1 have shown promising results in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, in case of positive hormone receptors in combination with adjuvant hormone therapy. Complementary radiotherapy will be allowed as per lines guide; * Availability of adequate information regarding treatment with adjuvant T-DM1 in accordance with the objectives of the study; * Written informed consent for the prospective part and, if possible, for the recruited patients retrospectively Exclusion Criteria: * Concomitant treatments with other biological agents; * Absence of clinical data that allow the correct analysis of the primary and secondary objectives; * Patients with a history of other malignant neoplasms; * Contraindications to the use of T-DM
Where this trial is running
Rome, Rome
- "Regina Elena" National Cancer Institute — Rome, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Patrizia Vici, Doctor
- Email: patrizia.vici@ifo.it
- Phone: +39 06-5266.5698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.