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.

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06272799

Run by

Regina Elena Cancer Institute

People needed

160

Starts

2022-09-20

Expected to finish

2024-09-20

Last updated by the study team

2024-09-19

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• "Regina Elena" National Cancer Institute — Rome, Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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