TDXD in Metastatic HER2-Positive Breast Cancer

NCT07778407 | Completed

• 1 other identifier: 25-091
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Advanced Malignancies

Keywords

TDXD; Her2 positive; metastatic; breast cancer

Outcome Measures

Primary Outcomes (3)

• Disease Control Rate (DCR)

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

  2 years

• PFS

  time from treatment initiation to progression or death

  2 years

• OS

  time from treatment initiation to death from any cause

  2 years

Secondary Outcomes (1)

• Toxcicity

  2 years

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic Her2 positive breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

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

Madinah, Saudi Arabia

Location

Related Publications (1)

• Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20.

  PMID: 37086745 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mohamed Ali Elbaiomy, Medical Oncology Consultant

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 21, 2026
• Study Start: February 1, 2023
• Primary Completion: February 10, 2026
• Study Completion: May 1, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

SA (1)