Trial · NCT04529044
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
NCT04529044, Phase 2, Recruiting, OHSU Knight Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer. Trials, record NCT04529044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04529044
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
- NCT number
- NCT04529044
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 10 participants, estimated
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
- Interventions
- Biopsy, Biospecimen Collection, Computed Tomography, Gallium Ga 68-DOTATATE, Lutetium Lu 177 Dotatate, Positron Emission Tomography
- First posted
- 2020-08-27
- Last updated
- 2026-06-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | Up to 3 months post-therapy | Using the intent to treat (ITT) set and the efficacy analysis set, each ORR will be reported as a point estimate along with a 2-sided 95% exact confidence interval (CI). |
| Secondary | Disease control rate (DCR) | Up to 3 months post-therapy | A point estimate and 2-sided 95% CI will be provided for the DCR, defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) (as assessed by the investigator per Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1). |
| Secondary | Duration of response (DOR) | Up to 12 months post-therapy | DOR will be estimated on responding participants and plotted with cumulative incidence functions: one curve for the first occurrence of recurrence, progression, or disease-related death and one curve for deaths in the absence of disease recurrence or progression. |
| Secondary | Progression-free survival | Up to 12 months post-therapy | PFS will be plotted using a Kaplan-Meier curve and reported with median survival and a 95% CI. |
| Secondary | Incidence of adverse events (AEs) | Up to 3 months post-therapy | The severity of the AE will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Study drug-related AEs are those assessed by investigator as definitely or probably related. Using the safety analysis set, the incidence of treatment emergent adverse events (TEAEs) and non-treatment-related AEs will be determined for study participants who receive at least one dose of lutetium Lu 177 dotatate (177Lu- DOTATATE). The point estimate and 95% CI will be reported for overall toxicities as well as for each major organ category. |
| Secondary | Duration of stable disease | Up to 12 months post-therapy |
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/NCT04529044
GET https://conductscience.org/api/trials/v1/NCT04529044/registered