Triple Negative Breast CancerNCT07092254
Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer
An observational study of Triple Negative Breast Cancer, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This transnational noninterventional study aims to gather real-world evidence on locally recurrent inoperable (hereafter referred to as advanced) or metastatic TNBC (a/m TNBC) biomarker testing, treatment patterns by line of therapy, and outcomes to contextualize findings of TROPION-Breast02 and TROPION-Breast05 in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- No drug
- How many people
- 760 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 adult patients residing in Canada, France, Spain, and the United Kingdom who received a diagnosis of hormone receptor (HR)-negative and HER2-negative advanced/metastatic TNBC any time from 1 January 2020 to 31 March 2024.
Patients meeting the following criteria will be included in the study:
- Histologically or cytologically documented diagnosis of HR-negative and HER2-negative locally recurrent inoperable TNBC (i.e., cannot be treated with curative intent) or advanced/metastatic TNBC from 1 January 2020 to 31 March 2024
- Negative for estrogen receptor with < 1% of tumor cells positive for estrogen receptor (ER) on immunohistochemistry (IHC)
- Negative for progesterone receptor with < 1% of tumor cells positive for progesterone receptor on IHC
- Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) HER2 guideline
- The test documented closest to the diagnosis date should be used as the reference
- Aged at least 18 years upon diagnosis of advanced/metastatic TNBC
- Known vital status (alive or deceased) as of last available follow-up date documented within the medical record
Patients meeting any of the following exclusion criteria will not be eligible for the study:
- Diagnosis of other prior primary cancers or malignancies (except nonmelanoma skin cancer) unless curatively treated with no evidence of disease for at least 3 years before diagnosis of advanced/metastatic TNBC
- Ever received treatment as part of any clinical trial of an investigational product for cancer
- No available medical record entry in the 90 days before or after diagnosis of advanced/metastatic TNBC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer in Selected Ex-US Countries
This transnational noninterventional study aims to gather real-world evidence on locally recurrent inoperable (hereafter referred to as advanced) or metastatic TNBC (a/m TNBC) biomarker testing, treatment patterns by line of therapy, and outcomes to contextualize findings of TROPION-Breast02 and TROPION-Breast05 in selected settings outside the United States (US), including Canada, the United Kingdom (UK), France, and Spain.
Read the detailed description
This study will document cancer characteristics, real-world cancer treatment patterns, clinical outcomes, and clinical events of interest in patients with locally recurrent inoperable or metastatic triple-negative breast cancer. No study or investigational drug will be administered in this non-interventional study; however, a retrospective review of medical records will be conducted.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- No drug
- Keywords
- Triple Negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugDrug
No study drug will be administered in this non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Advanced/metastatic TNBC | Adult patients who received a diagnosis of HR-negative and HER2-negative advanced/ metastatic TNBC any time from 1 January 2020 to 31 March 2024. Receives: Drug: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease)
Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.
Measured: From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months
Treatment sequencing on or after the diagnosis date for advanced, metastatic TNBC
Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.
Measured: From date of initial diagnosis of advanced, metastatic TNBC until end of follow-up, up to approximately 15 months
Real-world disease-free interval (rwDFI)
Real-world disease-free interval (rwDFI) is assessed from the completion of treatment with curative intent (either date of primary breast tumor surgery or date of last dose of systemic anticancer therapy [not including endocrine therapy], whichever occurred last) and the first documented local or distant disease recurrence date
Measured: From the completion of treatment with curative intent (either date of breast tumor surgery or date of last dose of systemic therapy (whichever occurred last) and the first local or distant disease recurrence date, up to approximately 15 months
Clinician-defined real-world progression-free survival (rwPFS)
Clinician-defined rwPFS is assessed from the index date and from the start of each line of therapy.
Measured: From the start of each line of therapy until end of follow up, up to approximately 15 months
Overall survival
OS is assessed from the index date and from the start of each line of therapy.
Measured: From the start of each line of therapy until end of follow-up, up to approximately 15 months
Occurrence of clinical events of interest
The occurrence of the following clinical events of interest will be assessed during each therapy line: Oral mucositis/stomatitis, Interstitial lung disease/pneumonitis, OSE, Diarrhea, Nausea/vomiting, Anemia, Neutropenia, Febrile neutropenia, Leukopenia, Lymphopenia, Thrombocytopenia.
Measured: From the start of each line of therapy until end of follow-up, up to approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Sep 2025
- Primary completion28 Nov 2025
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092254
- Sponsor's protocol ID
- DS1062-0007-NIS-EPI
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2025
- Last updated
- 16 Oct 2026
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Care and Outcomes in Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer in Selected Ex-US Countries
- ClinicalTrials.gov ID
- NCT07092254
- Acronym / sponsor ID
- DS1062-0007-NIS-EPI
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Triple Negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 29 Jul 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 transnational noninterventional study aims to gather real-world evidence on locally recurrent inoperable (hereafter referred to as advanced) or metastatic TNBC (a/m TNBC) biomarker testing, treatment patterns by line of therapy, and outcomes to contextualize findings of TROPION-Breast02 and TROPION-Breast05 in selected settings outside the United States (US), including Canada, the United Kingdom (UK), France, and Spain.
Detailed description
This study will document cancer characteristics, real-world cancer treatment patterns, clinical outcomes, and clinical events of interest in patients with locally recurrent inoperable or metastatic triple-negative breast cancer. No study or investigational drug will be administered in this non-interventional study; however, a retrospective review of medical records will be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced/metastatic TNBC | – | Drug: No drugAdult patients who received a diagnosis of HR-negative and HER2-negative advanced/ metastatic TNBC any time from 1 January 2020 to 31 March 2024. |
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 adult patients residing in Canada, France, Spain, and the United Kingdom who received a diagnosis of hormone receptor (HR)-negative and HER2-negative advanced/metastatic TNBC any time from 1 January 2020 to 31 March 2024.
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 drugNo study drug will be administered in this non-interventional study. | Drug | Advanced/metastatic TNBC |
Primary outcome
Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease)
Time frame: From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months
Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.
Treatment sequencing on or after the diagnosis date for advanced, metastatic TNBC
Time frame: From date of initial diagnosis of advanced, metastatic TNBC until end of follow-up, up to approximately 15 months
Treatment sequencing Includes broad categories for surgery, radiotherapy, adjuvant and neoadjuvant chemotherapy, immunotherapy, and start and stop dates of systemic therapy.
Real-world disease-free interval (rwDFI)
Time frame: From the completion of treatment with curative intent (either date of breast tumor surgery or date of last dose of systemic therapy (whichever occurred last) and the first local or distant disease recurrence date, up to approximately 15 months
Real-world disease-free interval (rwDFI) is assessed from the completion of treatment with curative intent (either date of primary breast tumor surgery or date of last dose of systemic anticancer therapy [not including endocrine therapy], whichever occurred last) and the first documented local or distant disease recurrence date
Clinician-defined real-world progression-free survival (rwPFS)
Time frame: From the start of each line of therapy until end of follow up, up to approximately 15 months
Clinician-defined rwPFS is assessed from the index date and from the start of each line of therapy.
Overall survival
Time frame: From the start of each line of therapy until end of follow-up, up to approximately 15 months
OS is assessed from the index date and from the start of each line of therapy.
Occurrence of clinical events of interest
Time frame: From the start of each line of therapy until end of follow-up, up to approximately 15 months
The occurrence of the following clinical events of interest will be assessed during each therapy line: Oral mucositis/stomatitis, Interstitial lung disease/pneumonitis, OSE, Diarrhea, Nausea/vomiting, Anemia, Neutropenia, Febrile neutropenia, Leukopenia, Lymphopenia, Thrombocytopenia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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.
Director 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 Triple Negative 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?
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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease) (time frame: From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months). The study lists 6 primary outcomes in all. 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 16 Oct 2026.