Trial · NCT06954480
Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer
NCT06954480, Phase 2, Recruiting, Queen Mary University of London
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer. Trials, record NCT06954480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06954480
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer
- NCT number
- NCT06954480
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Queen Mary University of London
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Datopotamab Deruxtecan (Dato-DXd), Durvalumab
- First posted
- 2025-05-01
- Last updated
- 2026-05-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS is defined as the time from the date of randomisation to the date of first documented confirmed tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first in all patients. | PFS is defined as the time from the date of randomisation to date of first documented confirmed disease progression or death, which ever occurs first, assessed on average up to 12 months. | PFS is defined as the time from randomisation to disease progression or relapse (as assessed by the site radiologist and/or investigator, using RECIST, Version 1.1) or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first. For patients who have not died or experienced disease progression at the end of study, PFS will be censored on the last date the patient was known to be progression free. |
| Secondary | OS is defined as the time from date of randomisation to the date of death due to any cause in all patients. | From date of randomisation to the date of death due to any cause in all patients, assessed on average up to 12 months. | Overall survival is defined as the time from randomisation to death from any cause. All deaths will be included, whether they occur on study or following treatment discontinuation. For patients who have not died, overall survival will be censored at the date of last contact. |
| Secondary | DoR is defined as the time from first documentation of CR or PR to confirmed disease progression using RECIST 1.1, or death on study from any cause, whichever occurs first, in patients with objective response. | The time from first documentation of CR or PR to confirmed disease progression, or death on study from any cause, whichever occurs first in patients with objective response, assessed on average up to 12 months. | |
| Secondary | CBR is defined as the percentage of patients who have achieved at least one CR or PR or met the SD criteria at least once after randomisation for a minimum interval of 24 weeks continuously (using RECIST 1.1). | Up to 24 weeks | Clinical Benefit rate is defined as number of patients with complete or partial response or stable disease maintained ≥24 weeks (as assessed by the site radiologist and/or investigator, using RECIST1.1) divided by the number of patients in the analysis. Patients without a post-baseline tumour assessment will be considered to have no clinical benefit. An estimate of the clinical benefit rate and 95% CIs (Blyth-Still-Casella; 21-22) will be calculated for each treatment arm. CIs for the difference in clinical benefit rate (Satner and Snell 1980; Berger and Boos 1994; 23-24) will be calculated. The relative risk (treatment:control) will be reported along with the associated 95% confidence interval. Statistical inference will be evaluated using Chi-square statistic; the Fisher's exact test may be used if the expected counts in some cells are small. |
| Secondary | DoCB is calculated as time (in months) from randomisation to progression or death from any cause in patients with a clinical benefit. | From the time (in months) from randomisation to progression or death from any cause in patients with a clinical benefit, assessed on average up to 12 months.. | For patients with an objective response, duration of objective response is defined as the time from initial complete or partial response to disease progression or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first. For patients with a clinical benefit (objective response or stable disease maintained ≥24 weeks), duration of clinical benefit is defined as the time from randomisation to disease progression or death on study from any cause (defined as death within 30 days of the last study treatment), whichever occurs first. Methods for handling censoring and for analysis are the same as those described for PFS. |
| Secondary | Changes in quality of life measured by the time to deterioration (TTD) | From the time of enrollment to the safety visit (90 days +/- 7 days after the last dose.), assessed up to at least 122 PFS events have occured | Changes in quality of life measured by the time to deterioration (TTD) in Items 29 (overall health) and 30 (overall QoL) of the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) and the percentages of patients with a decrease or increase of ≥ 10 points on the global health status/HRQoL scale of the EORTC QLQ-C30 and on subsets, respectively. Patient reported outcome assessment is one type of clinical outcome assessment and is a general term referring to all outcomes and symptoms that are directly reported by the participant. PROs have become important in evaluating the efficacy and tolerability of study interventions in clinical studies and will aid in understanding of the benefit/risk evaluation. |
| Secondary | Incidence, nature and severity of adverse events with severity determined according to CTCAE v5.0. | From the time of enrollment to the safety visit (90 days +/- 7 days after the last dose.), assessed up to at least 122 PFS events have occurred |
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/NCT06954480
GET https://conductscience.org/api/trials/v1/NCT06954480/registered