Trial · NCT06102824
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
NCT06102824, Phase 2, Recruiting, Guangdong Provincial People's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Organoid-based Functional Precision Therapy for Advanced Breast Cancer. Trials, record NCT06102824. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06102824
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Organoid-based Functional Precision Therapy for Advanced Breast Cancer
- NCT number
- NCT06102824
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 252 participants, estimated
- Lead sponsor
- Guangdong Provincial People's Hospital
- Conditions
- HER2-negative Breast Cancer, Advanced Breast Cancer
- Interventions
- Organoid-guided treatment, Taxane, Capecitabine, Gemcitabine, Vinorelbine, Eribulin, Anthracycline, Carboplatin, Utidelone, Trastuzumab deruxtecan, Sacituzumab govitecan
- First posted
- 2023-10-26
- Last updated
- 2024-11-25
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 | Through study completion, with an expected average of 1 year | PFS is defined as the time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression according to RECIST version 1.1 or death due to any cause. Subjects who are alive with no objective documentation of (radiographic) disease progression by the data cutoff date for PFS analysis will be censored at the date of their last evaluable tumor assessment. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
| Secondary | Overall survival | Through study completion, with an expected average of 2 year | OS is defined as the time from the date of randomization to the date of death for any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive. |
| Secondary | Objective response rate | Through study completion, with an expected average of 1 year | ORR is defined as the sum of complete response (CR) rate and partial response (PR) rate according to RECIST version 1.1. CR is defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR is defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Disease control rate | Through study completion, with an expected average of 1 year | DCR is defined as the sum of CR rate, PR rate, and stable disease (SD) rate. SD is defined as neither sufficient shrinkage to qualify for PR (taking as reference the sum of diameters at baseline) nor sufficient increase to qualify for PD (taking as reference the smallest sum of diameters while on study). |
| Secondary | Clinical benefit rate | Through study completion, with an expected average of 1 year | CBR is defined as the sum of CR rate, PR rate, and more than 6 months' SD rate. |
| Secondary | Duration of response | Through study completion, with an expected average of 1 year | DoR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression, or death. DoR will be measured for responding subjects (PR or CR) only. Subjects who are progression-free at the time of the analyses will be censored at the date of the last evaluable tumor assessment. |
| Secondary | Time to response | Through study completion, with an expected average of 1 year | TTR is defined as the time from the date of randomization to the date of the first documentation of objective response (CR or PR). TTR will be measured for responding subjects (CR or PR) only. |
| Secondary | Adverse events | Through study completion, with an expected average of 1 year | Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
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/NCT06102824
GET https://conductscience.org/api/trials/v1/NCT06102824/registered