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

NCT06231693 | Terminated DMC FDA Drug

• 2 other identifiers: D9673R0003674911423.1.1001.0071
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Next Treatment

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• 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

  Through study completion, an average of 18 months

Study Arms (1)

Trastuzumab-deruxtecan

Drug: Trastuzumab deruxtecan

Interventions

Trastuzumab deruxtecan DRUG

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

Trastuzumab-deruxtecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Hospital Israelita Albert Einstein: collaborator

Study Sites (2)

Research Site

Porto Alegre, Rio Grande do Sul, Brazil

Location

Research Site

São Paulo, Brazil

Location

Related Links

• CSR\_Synopsis\_Redacted

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Italo Fernandes, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 30, 2024
• Study Start: December 4, 2023
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

BR (2)