Trial · NCT06176261
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
NCT06176261, Phase 2, Recruiting, Nancy Lin, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs. Trials, record NCT06176261. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06176261
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
- NCT number
- NCT06176261
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 58 participants, estimated
- Lead sponsor
- Nancy Lin, MD
- Conditions
- Breast Cancer, Breast Cancer Female, Metastatic Triple-Negative Breast Carcinoma, ER Positive Breast Cancer, HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, ER-negative Breast Cancer
- Interventions
- Datopotamab Deruxtecan
- First posted
- 2023-12-19
- Last updated
- 2026-08-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in RANO-BM Criteria | 3 years | The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RANO-BM criteria defined protocol section 11.1.1. |
| Secondary | Objective Response Rate (ORR) | 3 years | The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria. |
| Secondary | Clinical Benefit Rate at 18 weeks (CBR18) | 18 Weeks | CBR defined as proportion of participants with defined as intracranial CR, intracranial PR, or stable disease (SD) in both intracranial and extracranial sites ≥ 18 (CBR18) . In the case of intracranial CR or PR, to be considered clinical benefit, extracranial disease must also be stable or better at the time of intracranial response. CBR will be reported for Cohort A and Cohort B only |
| Secondary | Clinical Benefit Rate at 24 weeks (CBR24) | 24 Weeks | CBR defined as proportion of participants with defined as intracranial CR, intracranial PR, or stable disease (SD) in both intracranial and extracranial sites ≥ 24 (CBR24) . In the case of intracranial CR or PR, to be considered clinical benefit, extracranial disease must also be stable or better at the time of intracranial response. CBR will be reported for Cohort A and Cohort B only |
| Secondary | Median Progression-Free Survival (PFS) | Assessed from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years | Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per RANO-BM criteria. or death, or is censored at time of last disease assessment. |
| Secondary | Median Overall Survival (OS) | Assessed from date of enrollment until the date of death from any cause, up to 3 years | Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. |
| Secondary | Site of First Progression | Assessed from date of enrollment until the date of first progression from any cause, up to 3 years | Site of first progression defined as the number of participants has progression in each sites. Progression defined per RANO-BM criteria. |
| Secondary | Grade 3-5 Treatment-related Toxicity Rate | From time of first dose of study treatment through 30 days after last dose of treatment, up to 3 years | All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06176261
GET https://conductscience.org/api/trials/v1/NCT06176261/registered