NCT06362616

Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: 51 Years
• Healthy volunteers: Not accepted

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 or DCIS.

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 fibrosis/induration 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 or DCIS. Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Preoperative accelerated partial breast irradiation	Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast
PROCEDURE	Breast conserving surgery	Patients will be treated with breast conserving surgery.
PROCEDURE	Sentinel node procedure	Patients will undergo a (repeat) sentinel node procedure.
PROCEDURE	Biopsy track removal	The biopsy track will be surgically removed.

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-10-11
• Completion: 2027-04-11
• First posted: 2024-04-12
• Last updated: 2026-01-20

Locations

1 site across 1 country: Netherlands