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

AstraZeneca2 enrolled

Overview

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.

Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

Trastuzumab deruxtecanDRUG

Patients with RE\<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Research Site

Porto Alegre, Rio Grande do Sul, Brazil

Research Site

São Paulo, Brazil

Outcomes

Primary Outcomes

Time to Next Treatment

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Response Rate

Time frame: Through study completion, an average of 18 months

Real World Progression Free Survival

Time frame: Through study completion, an average of 18 months

Real World Overall Survival

Time frame: Through study completion, an average of 18 months

Epidemiological Features

Age, comorbidities, somatic mutations, pattern of HER2 testing.

Time frame: Through study completion, an average of 18 months

Data from ClinicalTrials.gov

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