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

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AstraZeneca

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Drug: Trastuzumab deruxtecan

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06231693
74911423.1.1001.0071
D9673R00036

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Trastuzumab-deruxtecan
Treatment:
Drug: Trastuzumab deruxtecan

Trial contacts and locations

2

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Central trial contact

Italo Fernandes, MD

Data sourced from clinicaltrials.gov

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