Breast CancerNCT06231693
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
An observational study of Breast Cancer, run by AstraZeneca at 2 sites in Brazil.
Trial summary
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE<10%) metastatic HER2-Low breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab deruxtecan
- How many people
- 2 participants
- Where
- 2 sitesBrazil
- Study dates
- 4 Dec 2023to 26 Mar 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, with metastatic HER2-Low/ER ≤10% breast tumors, from Brazilian population, who were given TDXd as per usual prescription from their physician
Who may be able to join
- Aged above 18 years old;
- Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer;
- Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line;
- Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.
Who cannot join
- Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms);
- Have other active neoplasms (except from non-melanoma skin tumors);
- Have serious or active non-oncology lung diseases;
- Have other primary and concurrent breast tumor with differing receptor profiles.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
São Paulo
About this study
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE<10%) metastatic HER2-Low breast cancer.
Read the detailed description
Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab deruxtecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Patients with RE<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab-deruxtecan | Not described Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Next Treatment
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Response Rate
Measured: Through study completion, an average of 18 months
Real World Progression Free Survival
Measured: Through study completion, an average of 18 months
Real World Overall Survival
Measured: Through study completion, an average of 18 months
Epidemiological Features
Age, comorbidities, somatic mutations, pattern of HER2 testing.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start4 Dec 2023
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Why it stopped: The study was stopped due to a realignment of strategic priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein
- Responsible party
- Sponsor
- Investigators
- Italo Fernandes, MD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231693
- Sponsor's protocol ID
- D9673R00036
- Other IDs
- 74911423.1.1001.0071
- Status last verified
- Apr 2025
- First submitted
- 11 Jan 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
- ClinicalTrials.gov ID
- NCT06231693
- Acronym / sponsor ID
- D9673R00036
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped due to a realignment of strategic priorities
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 30 Jan 2024 (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 national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE<10%) metastatic HER2-Low breast cancer.
Detailed description
Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab-deruxtecan | – | Drug: Trastuzumab deruxtecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, with metastatic HER2-Low/ER ≤10% breast tumors, from Brazilian population, who were given TDXd as per usual prescription from their physician
Key inclusion criteria (4 listed)
- Aged above 18 years old;
- Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer;
- Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line;
- Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.
Key exclusion criteria (4 listed)
- Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms);
- Have other active neoplasms (except from non-melanoma skin tumors);
- Have serious or active non-oncology lung diseases;
- Have other primary and concurrent breast tumor with differing receptor profiles.
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 deruxtecanPatients with RE<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting | Drug | Trastuzumab-deruxtecan |
Primary outcome
Time to Next Treatment
Time frame: Through study completion, an average of 1 year
4 secondary outcomes
Response Rate
Time frame: Through study completion, an average of 18 months
Real World Progression Free Survival
Time frame: Through study completion, an average of 18 months
Real World Overall Survival
Time frame: Through study completion, an average of 18 months
Epidemiological Features
Time frame: Through study completion, an average of 18 months
Results and safety
The study was stopped early (reason given: The study was stopped due to a realignment of strategic priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- CSR\_Synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
Italo Fernandes, MD principal investigator
Hospital Israelita Albert Einstein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 2 sites in Brazil.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 was stopped early (reason given: The study was stopped due to a realignment of strategic priorities). Results are not available in the source record.
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?
Time to Next Treatment (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2025.