Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362616
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-28
Brief Title:
Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPBI-3
Brief Summary:
This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation PAPBI in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer
Detailed Description:
Standard treatment for an ipsilateral breast recurrence is a salvage mastectomy However repeat breast conserving therapy involving breast conserving surgery BCS and postoperative re-irradiation is a feasible alternative for a selected group of patients In the primary setting accelerated partial breast irradiation APBI is an international accepted treatment for a subset of breast cancer patients Preoperative APBI PAPBI leads to low complication rates limited fibrosisinduration in a small volume and good to excellent cosmetic results compared with results reported after postoperative APBI
The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer
Patients undergo PAPBI 5 times 5 x 52 Gray One-two weeks after completion of PAPBI patients undergo BCS
The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer
Patients undergo PAPBI 5 times 5 x 52 Gray One-two weeks after completion of PAPBI patients undergo BCS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None