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NCT Number: 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.

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.

Recruiting

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location status: Recruiting

Location contact

Patrizia Vici, Doctor

CONTACT

[email protected]

+39 06-5266.5584 ext. +39

About this study

Patients affected by will be included in the study and analyzed HER2 positive breast cancer with residual invasive disease after neoadjuvant chemotherapy, treated consecutively with adjuvant T-DM1 at the various Italian oncology centers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-DM1 adjuvant

Drug

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

Primary outcomes

  1. Evaluate the tolerability.

    Time frame: 24 months

    Evaluate the tolerability of the treatment in terms of adverse events, defined according to Common Terminology Criteria for Adverse Events (CTCAE, version 4), in a population of patients treated with adjuvant T-DM1 in "real life"

Secondary outcomes

  1. Evaluate the effectiveness of treatment.

    Time frame: 24 months

    Evaluate in the "real life setting" the effectiveness of adjuvant treatment in terms of survival free from disease (Disease Free Survival, DFS) in patients with HER2 positive breast cancer and residual invasive disease (on T and/or on N) after neoadjuvant chemotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia Vici, Doctor

CONTACT

[email protected]

+39 06-5266.5698 ext. +39

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

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.

Acronym: ATD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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