Trial · NCT06533826
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
NCT06533826, Phase 2, Recruiting, Ana C Garrido-Castro, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd. Trials, record NCT06533826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06533826
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
- NCT number
- NCT06533826
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 357 participants, estimated
- Lead sponsor
- Ana C Garrido-Castro, MD
- Conditions
- Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer
- Interventions
- Trastuzumab Deruxtecan, Datopotamab Deruxtecan
- First posted
- 2024-08-01
- Last updated
- 2026-08-26
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate in ADC1 (Group 1) Cohort | The observation period related to this endpoint is up to 36 months. | Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using RECIST 1.1 criteria as defined per protocol. |
| Primary | Objective Response Rate in ADC2 (Group 2) Cohort | The observation period related to this endpoint is up to 36 months. | Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using RECIST 1.1 criteria as defined per protocol. |
| Secondary | Median Progression Free Survival in ADC1 (Group 1) Cohort | The observation period related to this endpoint is up to 36 months. | PFS based on Kaplan-Meier methodology will be defined as the time from randomization until the identification of disease progression or death, whichever occurs first. Subjects without disease progression or death at the time of analysis will be censored at the date of last disease evaluation. |
| Secondary | Median Overall Survival (OS) in ADC1 (Group 1) Cohort | The observation period related to this endpoint is up to 5 years. | Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant. |
| Secondary | Clinical Benefit Rate (CBR) in ADC1 (Group 1) Cohort | The observation period related to this endpoint is up to 36 months. | Clinical Benefit Rate (CBR) is defined as the proportion of participants with CR, PR and stable disease (SD) for ≥ 24 weeks as the best overall response. |
| Secondary | Time to Progression (TTP) in ADC1 (Group 1) Cohort | The observation period related to this endpoint is up to 36 months. | Time to Progression (TTP) is defined as the time from registration to ADC1 to progression, or censored at date of last disease evaluation for those without progression reported based on Kaplan-Meier methodology. |
| Secondary | Time to Response (TTR) in ADC1 (Group 1) Cohort | The observation period related to this endpoint is up to 36 months. | The time to objective response is defined as the time from registration to the date of the first documented CR or PR (whichever is first recorded). |
| Secondary | Duration of Response (DOR) | The observation period related to this endpoint is up to 36 months. | The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause). Participants without reported events are censored at the last disease evaluation. |
| Secondary | Grade 3-5 Treatment-Related Toxicity Rate in ADC1 (Group 1) Cohort | The observation period related to this endpoint is up to 36 months. | The percentage of participants who experienced a maximum grade 3-5 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms. |
| Secondary | Change in HER2 Expression from Baseline to Progression | The observation period related to this endpoint is up to 36 months. | The evaluation of change in HER2 expression within each cohort will be based on a paired t-test (absolute difference) using a two-sided alpha = 0.05 for each cohort with no adjustment for multiplicity due to the exploratory nature of these analyses. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
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/NCT06533826
GET https://conductscience.org/api/trials/v1/NCT06533826/registered