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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06231693
• Other study ID #: D9673R00036
• Secondary ID: 74911423.1.1001.
• Status: Active, not recruiting
• Start date: December 4, 2023
• Est. completion date: May 27, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 27, 2024
• Est. primary completion date: May 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Next Treatment		Through study completion, an average of 1 year
Secondary	Response Rate		Through study completion, an average of 18 months
Secondary	Real World Progression Free Survival		Through study completion, an average of 18 months
Secondary	Real World Overall Survival		Through study completion, an average of 18 months
Secondary	Epidemiological Features	Age, comorbidities, somatic mutations, pattern of HER2 testing.	Through study completion, an average of 18 months