HER2-positive Breast CancerNCT06833268
Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan
An observational study of HER2-positive Breast Cancer, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- No drug
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 16 Jun 2025
- 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: The study population will consist of adults in the Flatiron mBC EDM who were diagnosed with HER2+ mBC during the study period and initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting.
Who may be able to join
- Patients must meet all the inclusion criteria below to be included in the study population:
- Patients with evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011.
- Patients aged ≥18 years old at mBC diagnosis date.
- Patients with ≥1 T-DXd-containing LOT in the metastatic setting.
- Patients with evidence of a subsequent LOT following the first T-DXd-containing LOT in the metastatic setting. The LOT subsequent to the first T-DXd-containing LOT in the metastatic setting will be the index LOT. Index date will be the index LOT start date.
- Patients whose closest HER2 test result (defined as immunohistochemistry [IHC] 3+ or in situ hybridization [ISH]+) recorded prior to or on the index date was a HER2+ test result.
- Patients with index date occurring at least 90 days prior to end of study period (March 31st, 2024).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Outcomes of Patients With HER2-positive (HER2+) Metastatic Breast Cancer (mBC) After Treatment With Trastuzumab Deruxtecan (T-DXd) in the United States
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape.
Read the detailed description
This study will utilize a longitudinal, demographically and geographically diverse database derived from Electronic Health Record data. No study medication will be supplied or administered for this protocol. The primary research objective is to describe the real-world progression-free survival (rwPFS) in HER2+ mBC patients who initiated a subsequent line of therapy (LOT) after a T-DXd-containing LOT in the metastatic setting.
Secondary research objectives include describing the real-world overall survival (rwOS), patient demographics and clinical characteristics, real-world time to next treatment (rwTTNT), and real-world time to treatment discontinuation (rwTTD) in HER2+ mBC patients who initiated a subsequent LOT after a T-DXd-containing LOT in the metastatic setting. Treatment patterns and sequencing in HER2+ mBC patients for subsequent LOTs following initial treatment with T-DXd will also be assessed.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- No drug
- Keywords
- HER2-positive breast cancer, Real-world outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugOther
This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive breast cancer | Patients diagnosed with HER2-positive metastatic breast cancer who initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting. Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Progression-free Survival (rwPFS)
rwPFS is defined as the interval in months between the index date until the first evidence of progression or death as documented by Flatiron.
Measured: Index date (index LOT start date) to date of earliest disease progression >14 days after the index date or date of death, whichever occurs first, up to approximately 13 years 3 months
Secondary outcomes (3)
Real-world Time to Next Treatment (rwTTNT)
rwTTNT is defined as the time in months between index date and initiation of next LOT, or death, whichever occurs first.
Measured: Index date (index LOT start date) to next LOT start date or, in the absence of next LOT, death, whichever occurs first, up to approximately 13 years 3 months
Real-world Time to Treatment Discontinuation (rwTTD)
rwTTD is defined as the time in months between index date and date of treatment discontinuation or death, whichever occurs first.
Measured: Index date (index LOT start date) to date treatment is discontinued, up to approximately 13 years 3 months
Treatment Patterns by Type of Line of Therapy
Treatment patterns will be described by LOT (monotherapy, combination therapy, and treatment sequence).
Measured: Index date (index LOT start date) to end of study period, up to approximately 13 years 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start20 Jan 2025
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- Retrospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Manager, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833268
- Sponsor's protocol ID
- U31402-0010-NIS-MA
- Status last verified
- Jul 2025
- First submitted
- 12 Feb 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Outcomes of Patients With HER2-positive (HER2+) Metastatic Breast Cancer (mBC) After Treatment With Trastuzumab Deruxtecan (T-DXd) in the United States
- ClinicalTrials.gov ID
- NCT06833268
- Acronym / sponsor ID
- U31402-0010-NIS-MA
- Conditions
- HER2-positive Breast Cancer
- Keywords
- HER2-positive breast cancer, Real-world outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 18 Feb 2025 (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.
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape.
Detailed description
This study will utilize a longitudinal, demographically and geographically diverse database derived from Electronic Health Record data. No study medication will be supplied or administered for this protocol. The primary research objective is to describe the real-world progression-free survival (rwPFS) in HER2+ mBC patients who initiated a subsequent line of therapy (LOT) after a T-DXd-containing LOT in the metastatic setting.
Secondary research objectives include describing the real-world overall survival (rwOS), patient demographics and clinical characteristics, real-world time to next treatment (rwTTNT), and real-world time to treatment discontinuation (rwTTD) in HER2+ mBC patients who initiated a subsequent LOT after a T-DXd-containing LOT in the metastatic setting. Treatment patterns and sequencing in HER2+ mBC patients for subsequent LOTs following initial treatment with T-DXd will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-positive breast cancer | – | Other: No drugPatients diagnosed with HER2-positive metastatic breast cancer who initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults in the Flatiron mBC EDM who were diagnosed with HER2+ mBC during the study period and initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting.
Key inclusion criteria (7 listed)
- Patients must meet all the inclusion criteria below to be included in the study population:
- Patients with evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011.
- Patients aged ≥18 years old at mBC diagnosis date.
- Patients with ≥1 T-DXd-containing LOT in the metastatic setting.
- Patients with evidence of a subsequent LOT following the first T-DXd-containing LOT in the metastatic setting. The LOT subsequent to the first T-DXd-containing LOT in the metastatic setting will be the index LOT. Index date will be the index LOT start date.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No drugThis is an non-interventional, observational study. No drug will be provided or administered as part of this protocol. | Other | HER2-positive breast cancer |
Primary outcome
Real-world Progression-free Survival (rwPFS)
Time frame: Index date (index LOT start date) to date of earliest disease progression >14 days after the index date or date of death, whichever occurs first, up to approximately 13 years 3 months
rwPFS is defined as the interval in months between the index date until the first evidence of progression or death as documented by Flatiron.
3 secondary outcomes
Real-world Time to Next Treatment (rwTTNT)
Time frame: Index date (index LOT start date) to next LOT start date or, in the absence of next LOT, death, whichever occurs first, up to approximately 13 years 3 months
Real-world Time to Treatment Discontinuation (rwTTD)
Time frame: Index date (index LOT start date) to date treatment is discontinued, up to approximately 13 years 3 months
Treatment Patterns by Type of Line of Therapy
Time frame: Index date (index LOT start date) to end of study period, up to approximately 13 years 3 months
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 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Project Manager study director
Daiichi Sankyo
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 HER2-positive Breast Cancer, run by Daiichi Sankyo at 1 site in United States.
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 0 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 8 Jul 2025. 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 United States. 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?
Real-world Progression-free Survival (rwPFS) (time frame: Index date (index LOT start date) to date of earliest disease progression >14 days after the index date or date of death, whichever occurs first, up to approximately 13 years 3 months). 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 Jul 2025.