Breast Advanced MalignanciesNCT07778407
TDXD in Metastatic HER2-Positive Breast Cancer
An observational study of Breast Advanced Malignancies, run by Mansoura University at 1 site in Saudi Arabia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Advanced Malignancies
- What is being tested?
- Trastuzumab deruxtecan (T-DXd)
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2023to 1 May 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: metastatic Her2 positive breast cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Salman Bin Abdulaziz Medical City (KSAMC) - Oncology Center
Madinah
About this study
Official title: Study of Efficacy and Toxicity of Trastuzumab Deruxtecan in Metastatic HER2-Positive Breast Cancer Patients: Single Center Experience, Madinah, 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
Read the 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
- Conditions
- Breast Advanced Malignancies
- Being tested
- Trastuzumab deruxtecan (T-DXd)
- Keywords
- TDXD, Her2 positive, metastatic, breast cancer
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
proportion of patients achieving CR + PR + SD per RECIST 1.1
Measured: 2 years
PFS
time from treatment initiation to progression or death
Measured: 2 years
OS
time from treatment initiation to death from any cause
Measured: 2 years
Secondary outcomes (1)
Toxcicity
Overall rate of drug-related adverse events and serious adverse events (SAEs)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Feb 2023
- Primary completion10 Feb 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Elbaiomy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778407
- Sponsor's protocol ID
- 25-091
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: typical for single-center retrospective cohort
Publications
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.
PubMed 37086745
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Toxicity of Trastuzumab Deruxtecan in Metastatic HER2-Positive Breast Cancer Patients: Single Center Experience, Madinah, Saudi Arabia
- ClinicalTrials.gov ID
- NCT07778407
- Acronym / sponsor ID
- 25-091
- Conditions
- Breast Advanced Malignancies
- Keywords
- TDXD, Her2 positive, metastatic, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic Her2 positive breast cancer
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab 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) | Drug | – |
Primary outcome
Disease Control Rate (DCR)
Time frame: 2 years
proportion of patients achieving CR + PR + SD per RECIST 1.1
PFS
Time frame: 2 years
time from treatment initiation to progression or death
OS
Time frame: 2 years
time from treatment initiation to death from any cause
1 secondary outcome
Toxcicity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publication: PubMed 37086745Andre 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.
- Individual participant dataSharing planned: Undecided. typical for single-center retrospective cohort
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Advanced Malignancies, run by Mansoura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07778407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.