TDXD in Metastatic HER2-Positive Breast Cancer

Study of Efficacy and Toxicity of Trastuzumab Deruxtecan in Metastatic HER2-Positive Breast Cancer Patients: Single Center Experience, Madinah, Saudi Arabia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07778407

Enrollment

Registered

2026-08-21

Start date

2023-02-01

Completion date

2026-05-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Advanced Malignancies

Keywords

TDXD, Her2 positive, metastatic, breast cancer

Brief summary

A single-center observational study (retrospective + prospective) evaluating the real-world efficacy and toxicity profile of Trastuzumab Deruxtecan (T-DXd) in adult female patients with HER2-positive metastatic breast cancer treated at KSAMC, Madinah, Saudi Arabia

Detailed description

Includes patient demographics, treatment lines (2nd line or beyond), dosing schedule, response assessment per RECIST 1.1, and adverse event grading per CTCAE v5.0

Interventions

DRUGTrastuzumab deruxtecan (T-DXd)

Dose 5.4 mg/kg IV Frequency Every 3 weeks (Q3W) Route Intravenous infusion Line of Therapy 2nd line (post-adjuvant progression) or 3rd line and beyond (de novo metastatic)

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patients aged ≥ 18 years * Histologically confirmed HER2-positive metastatic breast cancer * Progression during or within 6 months of finishing adjuvant anti-HER2 therapy (T-DXd as 2nd line), OR de novo metastatic disease previously treated with ≥ 2 lines of anti-HER2 therapy (T-DXd as 3rd line or beyond) * ECOG Performance Status 0-1 * LVEF ≥ 50% on echocardiography * Measurable lesions per RECIST v1.1 * Adequate hematologic, hepatic, and renal function

Exclusion criteria

* History of non-infectious interstitial lung disease (ILD) / pneumonitis requiring steroids * Active uncontrolled infection * Symptomatic/uncontrolled brain metastases * Severe cardiac dysfunction (LVEF \< 50%) * Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame	Description
Disease Control Rate (DCR)	2 years	proportion of patients achieving CR + PR + SD per RECIST 1.1
PFS	2 years	time from treatment initiation to progression or death
OS	2 years	time from treatment initiation to death from any cause

Secondary

Measure	Time frame	Description
Toxcicity	2 years	Overall rate of drug-related adverse events and serious adverse events (SAEs)

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026