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Completed

NCT Number: NCT07778407

TDXD in Metastatic HER2-Positive Breast Cancer

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

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Key information

Conditions

Breast Advanced Malignancies Breast Diseases Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

King Salman Bin Abdulaziz Medical City (KSAMC) - Oncology Center

Madinah, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab Deruxtecan (T-DXd)

Drug

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)

Primary outcomes

  1. Disease Control Rate (DCR)

    Time frame: 2 years

    proportion of patients achieving CR + PR + SD per RECIST 1.1

  2. PFS

    Time frame: 2 years

    time from treatment initiation to progression or death

  3. OS

    Time frame: 2 years

    time from treatment initiation to death from any cause

Secondary outcomes

  1. Toxcicity

    Time frame: 2 years

    Overall rate of drug-related adverse events and serious adverse events (SAEs)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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