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NCT05472792 · ClinicalTrials.gov registry record · Phase 2
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
A Phase 2 study of Breast Cancer and Quality of Life, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05472792: Recruiting Phase 2 study of Breast Cancer and Quality of Life, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05472792 is a Phase 2 study of Breast Cancer and Quality of Life that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 90 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05472792, a Phase 2 study of Breast Cancer and Quality of Life, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size \<2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.
Primary Outcome
To compare quality of life at 1 year after breast conserving surgery in those who receive adjuvant accelerated partial breast irradiation alone versus adjuvant endocrine therapy alone as measured by the EORTC QLQ-C30. Raw scores are linearly converted to a 0-100 scale with higher symptom scales reflecting increased levels of symptom burden.
Conditions Studied
Interventions
- RADIATION Accelerated Partial Breast Irradiation (APBI)
- DRUG tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2032-04-15 |
| Phase | Phase 2 |
What NCT05472792 shows while recruiting
NCT05472792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Accelerated Partial Breast Irradiation (APBI) is the first listed.
NCT05472792 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05472792 about?
NCT05472792 is a clinical study titled "Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy". The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include...
What is the current status of trial NCT05472792?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2022-05-17. Estimated completion is 2032-04-15.
What conditions does trial NCT05472792 study?
This clinical trial studies the following conditions: Breast Cancer, Quality of Life.
What interventions are being tested in trial NCT05472792?
The interventions under investigation include: Accelerated Partial Breast Irradiation (APBI) (RADIATION), tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene (DRUG).
Who is sponsoring clinical trial NCT05472792?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05472792 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05472792's enrollment target sits among peer trials
90 613th of 1224 higher than 604 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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