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TDXD in Metastatic HER2-Positive Breast Cancer

CompletedN/A

Sponsor: Mansoura University

Conditions: Breast Advanced Malignancies

Interventions: Trastuzumab deruxtecan (T-DXd)

Countries: Saudi Arabia

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Madinah, Saudi Arabia