Trial · NCT07394387
Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.
NCT07394387, Phase 2, Recruiting, The First Affiliated Hospital with Nanjing Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer. Trials, record NCT07394387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07394387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.
- NCT number
- NCT07394387
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 58 participants, estimated
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Interventions
- Sintilimab, Abraxane, Carboplatin, High-intensity focused ultrasound (HIFU)
- First posted
- 2026-02-06
- Last updated
- 2026-05-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Complete Response (pCR) Rate | Through study completion, an average of 1 year | |
| Secondary | Proportion of participants with a ≥2-fold increase in CD8+ T cell count or IFN-γ level | 2 weeks after HIFU treatment (and concurrent PD-1 inhibitor for Cohort B), which is immediately prior to the start of the first cycle of neoadjuvant chemotherapy. | |
| Secondary | Objective Response Rate (ORR) | Every 6 weeks during neoadjuvant therapy (at the end of cycles 2, 4, 6), up to up to 24 weeks | |
| Secondary | Event-Free Survival (EFS) | From enrollment until the first occurrence of an event, assessed up to 5 years. | |
| Secondary | Breast-Conserving Surgery (BCS) Rate | through study completion, an average of 1 year | |
| Secondary | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Baseline, 1 month post-intervention, 6 months post-intervention and at study completion (an average of 1 year) | |
| Other | Overall Survival (OS) | From enrollment until death, assessed up to 5 years. | |
| Other | predictive biomarkers for treatment efficacy | Biomarker samples are collected at baseline (pre-treatment) and at surgery (post-neoadjuvant therapy). Analysis will be performed after completion of patient enrollment and follow-up, through study completion, an average of 1 year. |
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.
Papers4
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.
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/NCT07394387
GET https://conductscience.org/api/trials/v1/NCT07394387/registered