Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-04 @ 1:21 PM
Study NCT ID:
NCT06008158
Status:
SUSPENDED
Last Update Posted:
2025-12-10
First Post:
2023-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Prospective Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation in Low-Risk, Hormone-Responsive Breast Cancer
Status:
SUSPENDED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
accrual goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD.
SECONDARY OBJECTIVES:
I. To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD.
II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD.
III. To determine the acute and late patient-reported radiation toxicity of APBI QD.
IV. To determine the acute and late physician-reported radiation toxicity of APBI QD.
V. To determine the cancer control outcomes of APBI QD.
EXPLORATORY OBJECTIVES:
I. To assess the health-related quality of life in patients treated with APBI QD.
II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI.
III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD.
OUTLINE:
Patients undergo APBI QD on consecutive business days for 5 treatments.
Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.
I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD.
SECONDARY OBJECTIVES:
I. To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD.
II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD.
III. To determine the acute and late patient-reported radiation toxicity of APBI QD.
IV. To determine the acute and late physician-reported radiation toxicity of APBI QD.
V. To determine the cancer control outcomes of APBI QD.
EXPLORATORY OBJECTIVES:
I. To assess the health-related quality of life in patients treated with APBI QD.
II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI.
III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD.
OUTLINE:
Patients undergo APBI QD on consecutive business days for 5 treatments.
Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-05718 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 23037 | OTHER | City of Hope Comprehensive Cancer Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |