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NCT06008158 · ClinicalTrials.gov registry record · Phase 2

Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca

A Phase 2 study, sponsored by City of Hope Medical Center.

Active
Registry status
Phase 2
Development phase
48
Enrollment target

NCT06008158: Active Phase 2 study, sponsored by City of Hope Medical Center.

NCT06008158 is a Phase 2 study that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06008158, a Phase 2 study, is active but no longer recruiting, sponsored by City of Hope Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.

Primary Outcome

Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is \>= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.

Interventions

  • RADIATION Accelerated Partial Breast Irradiation

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2023-09-29
Est. Completion 2027-05-26
Phase Phase 2
City of Hope Medical Center

582 total trials

What the registry record for NCT06008158 still lists

NCT06008158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

The record links to 0 conditions, and to 1 intervention - of which Accelerated Partial Breast Irradiation is the first listed.

NCT06008158 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06008158 about?

NCT06008158 is a clinical study titled "Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca". This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the br...

What is the current status of trial NCT06008158?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2023-09-29. Estimated completion is 2027-05-26.

What interventions are being tested in trial NCT06008158?

The interventions under investigation include: Accelerated Partial Breast Irradiation (RADIATION).

Who is sponsoring clinical trial NCT06008158?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06008158's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 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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Source: ClinicalTrials.gov NCT06008158, the US trial registry maintained by the National Library of Medicine. NCT06008158 (small enrollment · none site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.