Trial · NCT05582499
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
NCT05582499, Phase 2, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy. Trials, record NCT05582499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05582499
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
- NCT number
- NCT05582499
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 716 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC), HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
- Interventions
Dalpiciclib, Pyrotinib, SHR-A1811, SHR-1316, Camrelizumab, SHR-A1921, Pertuzumab, Trastuzumab, Goserelin, Letrozole, Nab paclitaxel, Carboplatin, Epirubicin, Cyclophosphamide, Fluzoparib, Apatinib, Famitinib, HB1801, LEM, TQB2102, Benmelstobart, Anlotinib, TQB2868, Ivonescimab, JS207, JSKN003, HRS-4508, SHR-4602, paclitaxel, HRS-6209, 9MW2821, IBI354, Stereotactic Body Radiation Therapy (SBRT)
- First posted
- 2022-10-17
- Last updated
- 2026-05-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological complete response rate (pCR) | through study completion, up to 24 weeks | Pathological complete response rate |
| Secondary | invasive disease-free survival (iDFS) | Three-year Post-surgery Follow-up | To determine three-year invasive disease-free survival (iDFS) among the treatment arms |
| Secondary | Overall response rate (ORR) | up to 24 weeks | Complete response (CR) + partial response (PR) |
| Secondary | CTCAE scale (V4.0) | through study completion, an average of 1 year | 4\) To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V4.0) |
| Secondary | Evaluate gene expression profile during treatment | through study completion, up to 24 weeks | To measure gene expression profile of baseline and sequential tumor samples during treatment, through RNA-seq platform |
| Secondary | Number of peripheral blood mononuclear cells (PBMC) count during treatment | through study completion, up to 24 weeks | To measure number of peripheral blood mononuclear cells (PBMC) count from baseline and sequential blood samples during treatment, through Flow CytoMetry platform |
| Other | Biomarker analysis | through study completion, up to 24 weeks | Tumor tissues, paracancerous tissues, ctDNA, blood, fecal samples, tumor pathological whole slide images and MRI images collected from study participants will be used for discovering exploratory biomarkers. The associations between these biomarkers and treatment responses disease status will be investigated. |
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.
Papers2
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/NCT05582499
GET https://conductscience.org/api/trials/v1/NCT05582499/registered