Clinical trial NCT06231693: Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
Official title: Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Hospital Israelita Albert Einstein
First posted: 2024-01-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, with metastatic HER2-Low/ER ≤10% breast tumors, from Brazilian population, who were given TDXd as per usual prescription from their physician

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Time to Next Treatment
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Response Rate
timeFrame: Through study completion, an average of 18 months
measure: Real World Progression Free Survival
timeFrame: Through study completion, an average of 18 months
measure: Real World Overall Survival
timeFrame: Through study completion, an average of 18 months
measure: Epidemiological Features
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Research Site
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Italo Fernandes, MD
role: PRINCIPAL_INVESTIGATOR
References: