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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab deruxtecan

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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Research Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trastuzumab-deruxtecan	Drug: Trastuzumab deruxtecan; Patients with RE<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Next Treatment	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate		Through study completion, an average of 18 months
Real World Progression Free Survival		Through study completion, an average of 18 months
Real World Overall Survival		Through study completion, an average of 18 months
Epidemiological Features	Age, comorbidities, somatic mutations, pattern of HER2 testing.	Through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Italo Fernandes, MD, Hospital israelita Albert Einstein

Publications and helpful links

Helpful Links

• CSR_Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Actual): March 26, 2024
• Study Completion (Actual): March 26, 2024

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; Trastuzumab; Trastuzumab deruxtecan
• Other Study ID Numbers: D9673R00036; 74911423.1.1001.0071 (Other Identifier: Hospital Israelita Albert Einstein)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No