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
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2022-09-20
2024-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Retrospective cohort
80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized
T-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
Prospectively cohort
Additional 80 patients who meet the inclusion criteria will be enrolled prospectively
T-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
Interventions
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T-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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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Regina Elena Cancer Institute
OTHER
Responsible Party
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Locations
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"Regina Elena" National Cancer Institute
Rome, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RS1480/21
Identifier Type: -
Identifier Source: org_study_id
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