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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-04

Study Completion Date

2024-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425

Advanced or Metastatic Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3

Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab

NCT05744375

Locally Advanced Breast Cancer Metastatic Breast Cancer

TERMINATED PHASE2

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

NCT05950945

Breast Cancer

RECRUITING PHASE3

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE3

Trial of Trastuzumab Deruxtecan in Previously Treated HER2

NCT06750484

Breast Cancer Metastatic

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trastuzumab-deruxtecan

Trastuzumab deruxtecan

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trastuzumab deruxtecan

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No