Trial · NCT07581795
Study of Paclitaxel Polymeric Micelles Combined With HP and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer
NCT07581795, Phase 2, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Paclitaxel Polymeric Micelles Combined With HP and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer. Trials, record NCT07581795. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07581795
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Paclitaxel Polymeric Micelles Combined With HP and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer
- NCT number
- NCT07581795
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Advanced HER2-positive Breast Cancer
- Interventions
- Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab, Taxanes combined with trastuzumab and pertuzumab.
- First posted
- 2026-05-12
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate （ORR） | From enrollment to the end of treatment up to approximately 24 months | Objective Response Rate (ORR): Proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria. |
| Secondary | Progression-Free Survival (PFS) | From enrollment to the first evidence of PD or death from any cause up to approximately 24 months | PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. |
| Secondary | Overall Survival (OS) | From enrollment to the date of death up to approximately 60 months | Time from date of randomization to the date of death from any cause |
| Secondary | Safety Endpoints | From enrollment to the end of treatment up to approximately 24 months | Include adverse event profiles, incidence rates, dose reductions, treatment delays, and discontinuations due to adverse events. |
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.
Papers9
The papers the trial lists on ClinicalTrials.gov.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07581795
GET https://conductscience.org/api/trials/v1/NCT07581795/registered