Unresectable Triple-negative Breast CancerNCT07867470
TROPION Breast Respond in 1L TNBC
An observational study of Unresectable Triple-negative Breast Cancer and Metastatic Triple-negative Breast Cancer, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company.
Trial summary
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer
- What is being tested?
- Dato-DXd
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 Jan 2031
- 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: Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
Who may be able to join
- Age ≥18 years at the time of screening
- Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC defined as:
- Negative for ER
- Negative for progesterone receptor
- Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the ASCO-CAP HER2 guideline
- Patients must not be a candidate for PD-1/PD-L1 inhibitor therapy, defined as either the tumor was PD-L1 negative (Combine Positive Score (CPS < 10), or it was PD-L1 positive (CPS ≥ 10 ) and: have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer or patient was not eligible for IO therapy due to comorbidities precluding PD-1/PD-L1 inhibitor therapy
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- Patients had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer
- Decision to newly initiate therapy Dato-DXd according to the physician's choice per SmPC. If the patient received just one dose of Dato-DXd already, the patient can still be included retrospectively
- Written and signed Informed Consent (ICF) to participate in the study
Who cannot join
- Pregnancy or breastfeeding
- Patients who at time of data collection for this study are participating in an interventional study regardless of whether the study is double blind or open label. Patients that have participated in an interventional study which is completed but remain blinded are also excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Daiichi Sankyo Contact for Clinical Trial Information contact
About this study
Official title: A Prospective Non-Interventional Study (NIS) of Dato-DXd (Datopotamab Deruxtecan) in Adult Patients With Unresectable or Metastatic Triple-negative Breast Cancer in the First Line Setting.
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. This NIS will investigate the effectiveness of Dato-DXd, the demographic and clinical characteristics of the patients, and treatment patterns.
Read the detailed description
This is a multi-center, multi-country, prospective, NIS that will collect real-world clinical data on effectiveness, safety and patient reported tolerability data on oral mucositis/stomatitis and ocular surface events by using linguistically validated diaries from adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. In addition, data on quality of life will be collected using validated patient reported outcomes (EQ5D-5L, EQ-VAS).
- Being tested
- Dato-DXd
- Keywords
- Unresectable triple-negative breast cancer, Metastatic triple-negative breast cancer, Dato-DXd
- 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.
Dato-DXdDrug
This is a non-interventional study and no drug was administered.
| Study group | Role | What they receive |
|---|---|---|
| Dato-DXd | Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy who will be treated with Dato-DXd based on clinical routine care according to the proposed indication statement in the Summary of Product Characteristics (SmPC). Receives: Drug: Dato-DXd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Time to Next Treatment (rwTTNT1)
rwTTNT1 is defined as the length of time from index date to the date the patient received an administration of their next systemic treatment regimen or to their date of death if the patient died before initiation of next systemic treatment.
Measured: From index date to time up to approximately 50 months
Secondary outcomes (7)
Treatment Patterns of Neoadjuvant and Adjuvant Therapies
Measured: From index date up to approximately 50 months
Real-world Time to Next Treatment 2 (rwTTNT2)
rwTTNT2 is defined as the time from the start of Dato-DXd administration (1L) to the start of the second subsequent therapy (3L) or death.
Measured: From index date up to approximately 50 months
Real-world Time to Permanent Treatment Discontinuation of the Index Treatment (rwTTD1)
rwTTD1 is defined as the time between start of Dato-DXd administration and last administration or death.
Measured: From index date up to approximately 50 months
Reasons for rwTTNT1 and rwTNT2 Event
rwTTNT1 and rwTNT2 are defined as the number of participants categorized according to the reason for rwTTNT1 or rwTTNT2 event. Reasons may include disease progression, adverse events, death, or others.
Measured: From index date up to approximately 50 months
Real-world Overall Survival (rwOS)
rwOS is defined as time from index date to date of death from any cause.
Measured: From index date up to approximately 50 months
Number of Participants Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), and Adverse Events of Special Interest (AESIs)
Measured: From index date up to approximately 50 months
Prophylactic and Reactive Treatments Used for AESI Management
AESI management is defined as the clinical management of physician-reported adverse events of special interest (AESIs), including prophylactic and reactive interventions. Data collected may include treatment name, dose, frequency, and duration of use.
Measured: From index date up to approximately 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Triple-negative Breast CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867470
- Sponsor's protocol ID
- DS1062-0027-NIS-MA
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-Interventional Study (NIS) of Dato-DXd (Datopotamab Deruxtecan) in Adult Patients With Unresectable or Metastatic Triple-negative Breast Cancer in the First Line Setting.
- ClinicalTrials.gov ID
- NCT07867470
- Acronym / sponsor ID
- DS1062-0027-NIS-MA
- Keywords
- Unresectable triple-negative breast cancer, Metastatic triple-negative breast cancer, Dato-DXd
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 9 Oct 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.
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. This NIS will investigate the effectiveness of Dato-DXd, the demographic and clinical characteristics of the patients, and treatment patterns.
Detailed description
This is a multi-center, multi-country, prospective, NIS that will collect real-world clinical data on effectiveness, safety and patient reported tolerability data on oral mucositis/stomatitis and ocular surface events by using linguistically validated diaries from adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. In addition, data on quality of life will be collected using validated patient reported outcomes (EQ5D-5L, EQ-VAS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dato-DXd | – | Drug: Dato-DXdPatients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy who will be treated with Dato-DXd based on clinical routine care according to the proposed indication statement in the Summary of Product Characteristics (SmPC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
Key inclusion criteria (9 listed)
- Age ≥18 years at the time of screening
- Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC defined as:
- Patients must not be a candidate for PD-1/PD-L1 inhibitor therapy, defined as either the tumor was PD-L1 negative (Combine Positive Score (CPS < 10), or it was PD-L1 positive (CPS ≥ 10 ) and: have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer or patient was not eligible for IO therapy due to comorbidities precluding PD-1/PD-L1 inhibitor therapy
- Patients had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer
- Decision to newly initiate therapy Dato-DXd according to the physician's choice per SmPC. If the patient received just one dose of Dato-DXd already, the patient can still be included retrospectively
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding
- Patients who at time of data collection for this study are participating in an interventional study regardless of whether the study is double blind or open label. Patients that have participated in an interventional study which is completed but remain blinded are also excluded.
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 |
|---|---|---|
| Dato-DXdThis is a non-interventional study and no drug was administered. | Drug | Dato-DXd |
Primary outcome
Real-world Time to Next Treatment (rwTTNT1)
Time frame: From index date to time up to approximately 50 months
rwTTNT1 is defined as the length of time from index date to the date the patient received an administration of their next systemic treatment regimen or to their date of death if the patient died before initiation of next systemic treatment.
7 secondary outcomes
Treatment Patterns of Neoadjuvant and Adjuvant Therapies
Time frame: From index date up to approximately 50 months
Real-world Time to Next Treatment 2 (rwTTNT2)
Time frame: From index date up to approximately 50 months
Real-world Time to Permanent Treatment Discontinuation of the Index Treatment (rwTTD1)
Time frame: From index date up to approximately 50 months
Reasons for rwTTNT1 and rwTNT2 Event
Time frame: From index date up to approximately 50 months
Real-world Overall Survival (rwOS)
Time frame: From index date up to approximately 50 months
Number of Participants Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), and Adverse Events of Special Interest (AESIs)
Time frame: From index date up to approximately 50 months
Prophylactic and Reactive Treatments Used for AESI Management
Time frame: From index date up to approximately 50 months
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 9 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.
Daiichi Sankyo Contact for Clinical Trial Information contact
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Triple-negative Breast Cancer and Metastatic Triple-negative Breast Cancer, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company.
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 9 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Daiichi Sankyo Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world Time to Next Treatment (rwTTNT1) (time frame: From index date to time up to approximately 50 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 9 Oct 2026.