Trial · NCT05041101
Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer
NCT05041101, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2025-06-13
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer. Trials, record NCT05041101. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05041101
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer
- NCT number
- NCT05041101
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Breast Inflammatory Carcinoma, Recurrent Breast Inflammatory Carcinoma, Stage IV Breast Inflammatory Carcinoma
- Interventions
- Eribulin Mesylate, Grapiprant
- First posted
- 2021-09-10
- Last updated
- 2025-06-13
- Results first posted
- 2025-06-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Safety of Grapiprant and Eribulin Combination Treatment | Up to 21 days from the initial treatment | Dose-limiting toxicity was defined as probable, possible, and definite events that occurred in the first 21 days (Cycle 1), as prespecified in the protocol. |
| Primary | Determine the Efficacy of Grapiprant and Eribulin Combination Treatment | Up to 1 year | Clinical Benefit Rate (CBR) was defined as the ratio of patients who achieved a complete response (CR), partial response (PR), or stable disease (SD) (lasting \>24 weeks). |
| Secondary | Determine Objective Response Rate (ORR) | Up to 1 year | The percentage of the patients who achieved complete response (CR) or partial response (PR). |
| Secondary | Determine the Time to Progression (TTP) of the Proposed Treatment. | Up to 1 year | Time to progression (TTP), defined as the time from the start of grapiprant treatment to objective tumor progression (PD), was analyzed using the Kaplan-Meier method, and the median with 95% confidence intervals was reported. |
| Secondary | Determine the Duration of Response of the Proposed Treatment in Phase II | Up to 2 years | The time from observing the response to the grapiprant treatment until objective tumor progression (PD) |
| Secondary | Determine the Time to First Response of the Proposed Treatment in Phase II | Up to 2 years | The time from starting grapiprant treatment until observing the response. |
| Secondary | Determine Progression-free Survival (PFS) of the Proposed Treatment | Up to 1 year | Progression-free survival (PFS) was defined as the time from starting grapiprant treatment until objective tumor progression (PD) or death from any cause and was summarized using the Kaplan-Meier method, including the median with 95% confidence intervals. |
| Secondary | Determine the Overall Survival (OS) of the Proposed Treatment | Up to 1.5 year | Overall survival (OS) was defined as the time from starting grapiprant treatment until death from any cause and was summarized using the Kaplan-Meier method, including the median with 95% confidence intervals. |
| Secondary | Investigate the Predictive Biomarker for the Proposed Treatment | Baseline and Cycle 2 | Determine the association between treatment response and the change in prostaglandin E2 metabolite (PGEM) levels in urine samples collected pre- and post-treatment. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the Safety of Grapiprant and Eribulin Combination Treatment | Up to 21 days from the initial treatment | Termination was requested by study supporter IKENA oncology during Phase 1b. | participants | NUMBER |
| PRIMARY | Determine the Efficacy of Grapiprant and Eribulin Combination Treatment | Up to 1 year | Termination was requested by study supporter IKENA oncology during Phase 1b. | percentage of participants | NUMBER |
| SECONDARY | Determine Objective Response Rate (ORR) | Up to 1 year | Termination was requested by study supporter IKENA oncology during Phase 1b. | percentage of participants | NUMBER |
| SECONDARY | Determine the Time to Progression (TTP) of the Proposed Treatment. | Up to 1 year | Termination was requested by study supporter IKENA oncology during Phase 1b. | months | MEDIAN |
| SECONDARY | Determine the Duration of Response of the Proposed Treatment in Phase II | Up to 2 years | Participants treated at the RP2D in Phase II were intended to be evaluated. However, due to the study's termination during Phase Ib, no participants were analyzed for this objective. | ||
| SECONDARY | Determine the Time to First Response of the Proposed Treatment in Phase II | Up to 2 years | Participants treated at the RP2D in Phase II were intended to be evaluated. However, due to the study's termination during Phase Ib, no participants were analyzed for this objective. | ||
| SECONDARY | Determine Progression-free Survival (PFS) of the Proposed Treatment | Up to 1 year | Termination was requested by study supporter IKENA oncology during Phase 1b. | months | MEDIAN |
| SECONDARY | Determine the Overall Survival (OS) of the Proposed Treatment | Up to 1.5 year | Termination was requested by study supporter IKENA oncology during Phase 1b. | months | MEDIAN |
| SECONDARY | Investigate the Predictive Biomarker for the Proposed Treatment | Baseline and Cycle 2 | Patients with treatment response, compared with the non-responder group, were intended to be evaluated for changes in urine PGEM. However, due to the absence of treatment responders in this study, no patients were analyzed for this objective. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the Safety of Grapiprant and Eribulin Combination Treatment | Phase Ib - Dose Level 0 | 2 | participants | ||
| Determine the Efficacy of Grapiprant and Eribulin Combination Treatment | Phase Ib - Dose Level 0 | 0 | percentage of participants | ||
| Determine Objective Response Rate (ORR) | Phase Ib - Dose Level 0 | 0 | percentage of participants | ||
| Determine the Time to Progression (TTP) of the Proposed Treatment. | Phase Ib - Dose Level 0 | 1.54 | 95% Confidence Interval 1.38 to NA | months | |
| Determine Progression-free Survival (PFS) of the Proposed Treatment | Phase Ib - Dose Level 0 | 1.54 | 95% Confidence Interval 1.38 to NA | months | |
| Determine the Overall Survival (OS) of the Proposed Treatment | Phase Ib - Dose Level 0 | 10.1 | 95% Confidence Interval 4.57 to NA | months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase Ib - Dose Level 0 | 6 | |
| Overall Study | STARTED | Phase Ib - Dose Level -1 | 0 | |
| Overall Study | STARTED | Phase II | 0 | |
| Overall Study | COMPLETED | Phase Ib - Dose Level 0 | 0 | |
| Overall Study | COMPLETED | Phase Ib - Dose Level -1 | 0 | |
| Overall Study | COMPLETED | Phase II | 0 | |
| Overall Study | NOT COMPLETED | Phase Ib - Dose Level 0 | 6 | |
| Overall Study | NOT COMPLETED | Phase Ib - Dose Level -1 | 0 | |
| Overall Study | NOT COMPLETED | Phase II | 0 |
Source ClinicalTrials.gov
Adverse events240
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 | Anemia | Blood and lymphatic system disorders | Phase Ib - Dose Level 0 | 4 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Phase Ib - Dose Level -1 | 0 | ||
| other | Anemia | Blood and lymphatic system disorders | Phase II | 0 | ||
| other | Sinus Tachycardia | Cardiac disorders | Phase Ib - Dose Level 0 | 1 | 6 | |
| other | Sinus Tachycardia | Cardiac disorders | Phase Ib - Dose Level -1 | 0 | ||
| other | Sinus Tachycardia | Cardiac disorders | Phase II | 0 | ||
| other | Abdominal Pain | Gastrointestinal disorders | Phase Ib - Dose Level 0 | 1 | 6 | |
| other | Abdominal Pain | Gastrointestinal disorders | Phase Ib - Dose Level -1 | 0 | ||
| other | Abdominal Pain | Gastrointestinal disorders | Phase II | 0 | ||
| other | Ascites | Gastrointestinal disorders | Phase Ib - Dose Level 0 | 1 | 6 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase Ib - Dose Level 0 | 6 | 6 |
| Total, all-cause mortality | Phase Ib - Dose Level -1 | 0 | 0 |
| Total, all-cause mortality | Phase II | 0 | 0 |
| Total, other adverse events | Phase Ib - Dose Level 0 | 6 | 6 |
| Total, other adverse events | Phase Ib - Dose Level -1 | 0 | 0 |
| Total, other adverse events | Phase II | 0 | 0 |
| Total, serious adverse events | Phase Ib - Dose Level 0 | 4 | 6 |
| Total, serious adverse events | Phase Ib - Dose Level -1 | 0 | 0 |
| Total, serious adverse events | Phase II | 0 | 0 |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05041101
GET https://conductscience.org/api/trials/v1/NCT05041101/events?page=2