Trial · NCT06224673
ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer
NCT06224673, Phase 2, Recruiting, Laura Huppert, MD, BA
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer. Trials, record NCT06224673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06224673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer
- NCT number
- NCT06224673
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Laura Huppert, MD, BA
- Conditions
- HER2 Low Breast Carcinoma, Triple Negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Interventions
- ARX788, Computed Tomography (CT), Biospecimen Collection, Amiloride
- First posted
- 2024-01-25
- Last updated
- 2026-06-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | Up to 1 year | Objective response rate (ORR) is defined as the proportion of participants who experience complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The ORR and corresponding two-sided exact 90% confidence intervals will be reported. |
| Secondary | Duration of response (DOR) | Up to 1 year | Duration of response (DOR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first, will be computed for participants with a BOR of CR or PR. Medians and corresponding two-sided 95% confidence intervals will be reported. |
| Secondary | Overall Best Response (BOR) | Up to 1 year | Best overall response (BOR) is defined as the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). |
| Secondary | Disease Control Rate (DCR) | Up to 1 year | The Disease control rate (DCR) is defined as the sum of PR, CR and stable disease (SD) divided by the number of response evaluable participants All-Subjects-as-Treated(AsaT). |
| Secondary | Median Progression Free Survival (PFS) | Up to 2 years | Progression-free survival (PFS) is defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first, will be computed for response evaluable participants (AsaT). Medians and corresponding two-sided 95% confidence intervals will be reported. |
| Secondary | Median Overall Survival (OS) | Up to 2 years | Overall survival (OS) is defined as the amount of time that elapses between the initiation of therapy (Cycle 1, Day 1 (C1D1) and the time of death from any cause. Medians and corresponding two-sided 95% confidence intervals will be reported. |
| Secondary | Proportion of participants with treatment-emergent adverse events (AEs) | Up to 1 year | Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. |
| Secondary | Percentage of participants adhering to the eye drop | Up to 1 year | Tolerability and adherence to eye toxicity prevention regimen will be reported as the percentage of participants who adhered to the regimen during the course of the study. |
| Secondary | Mean score on an eye pain scale | Up to 1 year | After each drop, participants will assess the amount of pain on a scale from 1 (lowest amount) to 10 (greatest amount). The mean and standard deviation of the pain scores by cohort will be reported |
| Secondary | Proportion of participants reporting ocular adverse events | Up to 1 year | The proportion of participants with a recorded grade \>=2 ocular AEs based on visual acuity, eye symptoms, cornea evaluation and intraocular pressure (mmHg) readings will be reported. |
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/NCT06224673
GET https://conductscience.org/api/trials/v1/NCT06224673/registered