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NCT04529044 · ClinicalTrials.gov registry record · Phase 2
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04529044: Recruiting Phase 2 study, sponsored by OHSU Knight Cancer Institute.
NCT04529044 is a Phase 2 study that is actively recruiting participants, run by OHSU Knight Cancer Institute. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04529044, a Phase 2 study, is actively recruiting participants, sponsored by OHSU Knight Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.
Primary Outcome
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).
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- RADIATION Gallium Ga 68-DOTATATE
- DRUG Lutetium Lu 177 Dotatate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2027-12-20 |
| Phase | Phase 2 |
What NCT04529044 shows while recruiting
NCT04529044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04529044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04529044 about?
NCT04529044 is a clinical study titled "177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer". This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targete...
What is the current status of trial NCT04529044?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2026-06-30. Estimated completion is 2027-12-20.
What interventions are being tested in trial NCT04529044?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Gallium Ga 68-DOTATATE (RADIATION), Lutetium Lu 177 Dotatate (DRUG).
Who is sponsoring clinical trial NCT04529044?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04529044's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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