Trial · NCT06731140
Reverse HER2-negative Immune Resistant Breast Cancer
NCT06731140, Phase 2, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reverse HER2-negative Immune Resistant Breast Cancer. Trials, record NCT06731140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06731140
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reverse HER2-negative Immune Resistant Breast Cancer
- NCT number
- NCT06731140
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- HER2 Negative Breast Cancer
- Interventions
- Retinoic Acid, anti-PD-1 antibody and chemotherapy
- First posted
- 2024-12-12
- Last updated
- 2025-11-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Baseline until disease progression or loss of clinical benefit, assessed up to 6 months | |
| Primary | Clinical Benefit Rate (CBR) | Baseline until disease progression or loss of clinical benefit, assessed up to 6 months | Clinical benefit rate (CBR) is defined as the proportion of subjects who achieve a complete response (CR), partial response (PR), or have durable stable disease (SD) after treatment. It is intended to measure a clinically meaningful and broader disease control effect. CBR includes subjects who have achieved CR and PR, as well as those who have maintained SD for a specified duration (≥24 weeks). The evaluation is based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Subjects must have measurable tumor lesions at baseline. The efficacy assessment is categorized into CR, PR, SD, and Progressive Disease (PD) according to RECIST 1.1 criteria. |
| Primary | Immune changes in peripheral blood | Baseline until disease progression or loss of clinical benefit, assessed up to 6 months | |
| Secondary | Disease Control Rate (DCR) | Baseline through end of study, assessed up to 6 months | |
| Secondary | Progression Free Survival (PFS) | Randomization to death from any cause, through the end of study, assessed up to 6 months | |
| Secondary | Safety and treatment-related AEs | Randomization to death from any cause, through the end of study, assessed up to 12 months | |
| Secondary | Biomarker analysis | Baseline until disease progression or loss of clinical benefit, assessed up to 6 months | Retinoic acid related genes, cell functions and microbes will be measured in pre-treatment and post-treatment samples (tumor tissue, blood and fecal samples) to predict therapy response. |
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/NCT06731140
GET https://conductscience.org/api/trials/v1/NCT06731140/registered