Trial · NCT04032080
LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer
NCT04032080, Phase 2, Completed, Baylor Research Institute; results first posted 2023-09-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer. Trials, record NCT04032080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04032080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer
- NCT number
- NCT04032080
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Baylor Research Institute
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Drug 1: LY3023414; Drug 2: Prexasertib
- First posted
- 2019-07-25
- Last updated
- 2026-10-27
- Results first posted
- 2023-09-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy (Objective Response Rate) | Through study completion, approximately 2 years and 8 months | To assess the objective response rate associated with LY3023414 and prexasertib in metastatic TNBC patients. Objective response is measured as prolonged clinical benefit; clinical benefit is defined as progression free survival on study therapy for at least 6 months. |
| Secondary | Efficacy (Duration of Response) | From the time that 6 months of progression free survival on study therapy was first met until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. | To assess duration of response to combination of LY3023414 and prexasertib in metastatic TNBC patients. Duration of response is measured as prolonged clinical benefit; clinical benefit is defined as progression free survival on study therapy for at least 6 months. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy (Objective Response Rate) | Through study completion, approximately 2 years and 8 months | All participants who received at least one dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy (Duration of Response) | From the time that 6 months of progression free survival on study therapy was first met until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. | All participants who received at least one dose of treatment. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy (Objective Response Rate) | LY3023414 + Prexasertib | 3 | Participants | ||
| Efficacy (Duration of Response) | LY3023414 + Prexasertib | 9 | Full Range 1 to 45 | weeks |
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 | LY3023414 + Prexasertib | 10 | |
| Overall Study | COMPLETED | LY3023414 + Prexasertib | 4 | |
| Overall Study | NOT COMPLETED | LY3023414 + Prexasertib | 6 |
Source ClinicalTrials.gov
Adverse events72
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 | Abdominal Pain | Musculoskeletal and connective tissue disorders | LY3023414 + Prexasertib | 2 | 10 | 2 |
| other | Abnormal HBA1C | Investigations | LY3023414 + Prexasertib | 2 | 10 | 2 |
| other | Abnormal LVEF | Cardiac disorders | LY3023414 + Prexasertib | 1 | 10 | 1 |
| other | Axillary Cellulitis | Infections and infestations | LY3023414 + Prexasertib | 1 | 10 | 1 |
| other | Axillary Pain | Musculoskeletal and connective tissue disorders | LY3023414 + Prexasertib | 1 | 10 | 1 |
| other | Axillary Swelling | Blood and lymphatic system disorders | LY3023414 + Prexasertib | 1 | 10 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | LY3023414 + Prexasertib | 3 | 10 | 3 |
| other | Chest Wall Pain | Musculoskeletal and connective tissue disorders | LY3023414 + Prexasertib | 1 | 10 | 1 |
| other | Bronchitis | Infections and infestations | LY3023414 + Prexasertib | 1 | 10 | 1 |
| other | Chest Pressure | General disorders | LY3023414 + Prexasertib | 1 | 10 | 1 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY3023414 + Prexasertib | 8 | 10 |
| Total, other adverse events | LY3023414 + Prexasertib | 10 | 10 |
| Total, serious adverse events | LY3023414 + Prexasertib | 3 | 10 |
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/NCT04032080
GET https://conductscience.org/api/trials/v1/NCT04032080/events?page=2