NCT06272799 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.
| NCT ID | NCT06272799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-09-20 |
| Primary Completion | 2024-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2022-09-20 with a primary completion date of 2024-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06272799 clinical trial?
This trial is open to female participants only, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06272799 currently recruiting?
Yes, NCT06272799 is actively recruiting participants. Contact the research team at patrizia.vici@ifo.it for enrollment information.
Where is the NCT06272799 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06272799 clinical trial?
NCT06272799 is sponsored by Regina Elena Cancer Institute. The trial plans to enroll 160 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.