Trial · NCT04142892
Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer
NCT04142892, Early phase 1, Completed, SOLTI Breast Cancer Research Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer. Trials, record NCT04142892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04142892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer
- NCT number
- NCT04142892
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Conditions
- Breast Cancer
- Interventions
- Onapristone
- First posted
- 2019-10-29
- Last updated
- 2022-04-01
- Other registries' IDs
- eudract:2019-001433-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Cell Cycle Arrest (CCCA) | after 3 weeks of ONA therapy | CCCA rate determined by Ki67 \< 2.7% |
| Secondary | IHC of tumor expression | after 3 weeks of ONA therapy | IHC of tumor expression of ER, PgR, CD24, CD44, ALDH1, Ser294-PgR, Ki67 |
| Secondary | PAM50 (Prediction Analysis of Microarray 50) subtype change | after 3 weeks of ONA therapy | PAM50 subtype changes upon ONA therapy |
| Secondary | antiproliferative effect | after 3 weeks of ONA therapy | Suppression of PAM50 11-gene proliferation signature according to PAM50 subtypes upon treatment.. These changes will be analyzed according to the formula: Mean suppression = 100 - \[geometric mean (post-treatment / pretreatment · 100)\]. |
| Secondary | proliferation score | after 3 weeks of ONA therapy | mean suppression of PAM50 11-gene proliferation signature according to PAM50 subtypes |
| Secondary | gene expression changes | after 3 weeks of ONA therapy | * expression of 770 genes across of 23 categories of BC tumor biology * changes in the expression of the 16-PgR target genes |
| Secondary | molecular markers in blood | after 3 weeks of ONA therapy | Estradiol and progesterone levels |
| Secondary | identification putative prognostic and predictive biomarkers | after 3 weeks of ONA therapy | * Development of a gene signature of response to ONA based on changes in the expression of 770 genes by the nCounter Breast 360TM panel in the tumor. * Analysis of the presence of ctDNA and its dynamics after ONA treatment. |
| Secondary | Adverse Events (AEs) | after 3 weeks of ONA therapy | Incidence, duration and severity of Adverse Events (AEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, including treatment discontinuations. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42215464 | DERIVED |
Source PubMed
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/NCT04142892
GET https://conductscience.org/api/trials/v1/NCT04142892/registered