Trial · NCT07205822
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
NCT07205822, Phase 3, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer. Trials, record NCT07205822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07205822
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
- NCT number
- NCT07205822
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 100 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Breast Cancer
- Interventions
- Dato-DXd
- First posted
- 2025-10-03
- Last updated
- 2026-10-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) per RECIST 1.1 as assessed by the investigator | From date of first dose of study intervention until disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed up to approximately 24 months | PFS is defined as time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by the investigator or death due to any cause. |
| Secondary | Proportion of participants with oral mucositis/stomatitis | From date of first dose of study intervention until 28 days after the last dose (Safety Follow-up) | Proportion of participants with oral mucositis/stomatitis |
| Secondary | Proportion of participants with ocular events | From date of first dose of study intervention until 28 days after the last dose (Safety Follow-up) | Proportion of participants with ocular events |
| Secondary | Proportion of participants with Grade 3 or higher Adverse Events (AEs) possibly related to Dato-DXd treatment | From date of first dose of study intervention until 28 days after the last dose (Safety Follow-up) | Grade 3 or higher adverse events possibly related to Dato-DXd treatment (Grade ≥ 3 treatment-related adverse events) according to NCI CTCAE 5.0. Possibly related is defined as reasonable possibility that the adverse event was caused by investigational product, as assessed by investigator. Missing responses are counted as possibly related. |
| Secondary | Clinical benefit rate (CBR) at 24 weeks | At 24 weeks after first dose | CBR at 24 weeks is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1 as assessed by the investigator and derived from the raw tumour data for at least 24 weeks after date of first dose. |
| Secondary | Objective response rate (ORR) | From date of first dose until disease progression or death, whichever occurs first, assessed up to approximately 24 months | ORR is defined as the proportion of participants with measurable disease at baseline who have a confirmed CR or confirmed PR, as assessed by the investigator and derived from raw tumour data per RECIST 1.1. |
| Secondary | Duration of response (DoR) | From the date of first documented confirmed response until disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed up to approximately 24 months | DoR will be defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by the investigator or death due to any cause. The analysis will include all dosed participants who have a confirmed response. |
| Secondary | Overall survival (OS) | From date of first dose of study intervention until death from any cause, assessed up to approximately 24-30 months | OS defined as the time from the date of the first dose of study intervention until the date of death due to any cause. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy |
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/NCT07205822
GET https://conductscience.org/api/trials/v1/NCT07205822/registered