Trial · NCT07492394
Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
NCT07492394, Phase 2, Recruiting, Hebei Medical University Fourth Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer. Trials, record NCT07492394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07492394
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
- NCT number
- NCT07492394
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Conditions
- Breast Cancer
- Interventions
- entinostat, Dalpiciclib, Letrozole
- First posted
- 2026-03-25
- Last updated
- 2026-04-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR | From baseline to end of neoadjuvant therapy (approximately 6 cycles, ~24 weeks | Objective Response Rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed according to RECIST v1.1 criteria. Tumor response must be confirmed by repeat imaging at least 4 weeks after the initial documentation of response. |
| Secondary | tpCR | At the time of definitive surgery (approximately 18-24 weeks after initiation of neoadjuvant therapy) | Total pathological complete response (tpCR) is defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes following neoadjuvant therapy, corresponding to ypT0/Tis, ypN0. |
| Secondary | Breast-conserving surgery (BCS) rate | At the time of definitive surgery | Breast-conserving surgery rate is defined as the proportion of participants who undergo breast-conserving surgery (lumpectomy) among all participants who proceed to definitive breast surgery after completion of neoadjuvant therapy. The classification of breast-conserving surgery is based on the operative report and pathology assessment. |
| Secondary | Proportion of participants achieving PEPI 0 | At the time of definitive surgery | PEPI 0 (Preoperative Endocrine Prognostic Index score of 0) is defined as meeting all of the following criteria at surgery after completion of neoadjuvant endocrine-based therapy: Pathologic tumor size: ypT1 or smaller (≤2 cm) Nodal status: ypN0 (no metastatic involvement in regional lymph nodes) Ki-67 proliferation index: ≤2.7% in the surgical specimen Estrogen receptor (ER): Allred score of 3-8 (ER-positive) Participants meeting all components are classified as achieving PEPI score = 0, indicating an extremely low risk of relapse. |
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/NCT07492394
GET https://conductscience.org/api/trials/v1/NCT07492394/registered