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Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil

NCT06231693

TerminatedN/A

Sponsor: AstraZeneca

Conditions: Breast Cancer

Interventions: Trastuzumab deruxtecan

Countries: Brazil

A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE\<10%) metastatic HER2-Low breast cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Aged above 18 years old;
* Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer;
* Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line;
* Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.

Exclusion Criteria:

* Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms);
* Have other active neoplasms (except from non-melanoma skin tumors);
* Have serious or active non-oncology lung diseases;
* Have other primary and concurrent breast tumor with differing receptor profiles.

Locations (2)

Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, Brazil