Trial · NCT04738292
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
NCT04738292, Phase 2, Terminated, University of Wisconsin, Madison; results first posted 2024-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study). Trials, record NCT04738292. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04738292
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
- NCT number
- NCT04738292
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Cancer
- Interventions
- Onapristone, Fulvestrant
- First posted
- 2021-02-04
- Last updated
- 2024-05-03
- Results first posted
- 2024-05-03
- Limitations and caveats
- Study was terminated early, sponsor closed study. Study not powered per protocol.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response (ORR) | up to 17 months | Best overall response of complete response (CR) or partial response (PR), as per RECIST 1.1. Point and 95% interval estimate of ORR will be evaluated accounting for possibility of early futility stopping. |
| Secondary | Number of Participants Experiencing Progression Free Survival (PFS) | up to 17 months | Time from date of enrollment to the date of first documented disease progression or death due to any cause. PFS will be described with Kaplan-Meier (KM) Curve and its pointwise asymptotic 95% confidence bounds. Median PFS if reached will be extracted from this KM estimator. |
| Secondary | Number of Participants With Disease Control (DCR) | up to 17 months | Best overall response of CR, PR or stable disease (SD) lasting for ≥ 24 weeks, as per RECIST 1.1. DCR will be estimated with relative frequency and exact two-sided 95% binomial confidence interval. |
| Secondary | Time to Response | up to 17 months | Time from registration to first documented response (CR or PR) will be evaluated with a cumulative incidence where death will be as a competing risk to response. |
| Secondary | Duration of Response | up to 17 months | Time between the first date of documented response to progression or death due to breast cancer. Duration of response will be assessed for a subgroup of subjects with observed response. The date of response will be denoted as time zero and time to progression or death will be evaluated with KM curve and 95% confidence interval (CI). Median time to response will be extracted from this KM curve. |
| Secondary | Incidence of Treatment-Related Adverse Events | up to 17 months | Type, frequency and severity of adverse events and laboratory abnormalities (according to CTCAE version 5.0) will be summarized with descriptive frequency tables. See Adverse Events Section for detailed summary. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Objective Response (ORR) | up to 17 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Progression Free Survival (PFS) | up to 17 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Disease Control (DCR) | up to 17 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Response | up to 17 months | Time to response could not be calculated as there was not a response to treatment within the study time points. | ||
| SECONDARY | Duration of Response | up to 17 months | Duration of Response could not be calculated because there was no response to treatment within the study time points. | ||
| SECONDARY | Incidence of Treatment-Related Adverse Events | up to 17 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Response (ORR) | Onapristone In Combination With Fulvestrant | 0 | Participants | ||
| Number of Participants Experiencing Progression Free Survival (PFS) | Onapristone In Combination With Fulvestrant | 1 year PFS | 0 | Participants | |
| Number of Participants Experiencing Progression Free Survival (PFS) | Onapristone In Combination With Fulvestrant | 17 month PFS | 0 | Participants | |
| Number of Participants With Disease Control (DCR) | Onapristone In Combination With Fulvestrant | 2 | Participants | ||
| Incidence of Treatment-Related Adverse Events | Onapristone In Combination With Fulvestrant | Participants Experiencing Grade 1 Adverse Events | 6 | Participants | |
| Incidence of Treatment-Related Adverse Events | Onapristone In Combination With Fulvestrant | Participants Experiencing Grade 2 Adverse Events | 1 | Participants | |
| Incidence of Treatment-Related Adverse Events | Onapristone In Combination With Fulvestrant | Participants Experiencing Grade 3 Adverse Events | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Onapristone In Combination With Fulvestrant | 11 | |
| Overall Study | COMPLETED | Onapristone In Combination With Fulvestrant | 10 | |
| Overall Study | NOT COMPLETED | Onapristone In Combination With Fulvestrant | 1 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Onapristone In Combination With Fulvestrant | 4 | 11 | 5 |
| other | Non-cardiac chest pain | General disorders | Onapristone In Combination With Fulvestrant | 3 | 11 | 3 |
| other | General disorders and administration site conditions - Other, specify | General disorders | Onapristone In Combination With Fulvestrant | 1 | 11 | 1 |
| other | Chills | General disorders | Onapristone In Combination With Fulvestrant | 1 | 11 | 1 |
| other | Facial pain | General disorders | Onapristone In Combination With Fulvestrant | 1 | 11 | 1 |
| other | Fever | General disorders | Onapristone In Combination With Fulvestrant | 1 | 11 | 2 |
| other | Injection site reaction | General disorders | Onapristone In Combination With Fulvestrant | 2 | 11 | 2 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Onapristone In Combination With Fulvestrant | 4 | 11 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Onapristone In Combination With Fulvestrant | 4 | 11 | 6 |
| other | Flank pain | Musculoskeletal and connective tissue disorders | Onapristone In Combination With Fulvestrant | 1 | 11 | 1 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Onapristone In Combination With Fulvestrant | 1 | 11 |
| Total, other adverse events | Onapristone In Combination With Fulvestrant | 11 | 11 |
| Total, serious adverse events | Onapristone In Combination With Fulvestrant | 3 | 11 |
Source ClinicalTrials.gov
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/NCT04738292
GET https://conductscience.org/api/trials/v1/NCT04738292/events?page=2