Trial · NCT07441512
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation
NCT07441512, Phase 2, Not yet recruiting, Hu Hai
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation. Trials, record NCT07441512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07441512
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation
- NCT number
- NCT07441512
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 26 participants, estimated
- Lead sponsor
- Hu Hai
- Conditions
- TNBC - Triple-Negative Breast Cancer, TNBC
- Interventions
- Inavolisib in Combination With Eribulin
- First posted
- 2026-03-02
- Last updated
- 2026-03-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR by Investigator assessment per RECIST 1.1 | 22 months | ORR by Investigator assessment per RECIST 1.1 |
| Secondary | Incidence and severity of adverse events (graded by CTCAE v5.0) | 22 months | |
| Secondary | Number of participants with Abnormal and clinically significant change from baseline in targeted vital signs | 22 months | |
| Secondary | Number of participants with Abnormal and clinical significant change from baseline in targeted clinical laboratory test results | 22 months | |
| Secondary | Secondary Outcome Measure | 22 months | The total cumulative dose of Inavolisib actually administered to each subject (unit: mg), calculated by summarizing the daily dosing records documented in the electronic data system or source documents. |
| Secondary | PFS by Investigator assessment per RECIST 1.1 | 22 months | |
| Secondary | Secondary Outcome Measure | 22 months | DoR \[Duration of Response\] by Investigator assessment per RECIST 1.1 |
| Secondary | Secondary Outcome Measure | 22 months | CBR \[Clinical Benefit Rate\] by Investigator assessment per RECIST 1.1 |
| Secondary | Overall survival (OS) | 22 months |
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/NCT07441512
GET https://conductscience.org/api/trials/v1/NCT07441512/registered