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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 51
Healthy Volunteers: f
View:

• Female patients ≥ 51 years

• Ipsilateral breast cancer; recurrence or second primary

• Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)

• Histologically proven estrogen receptor positive

• HER2neu negative or HER2neu positive (the latter should also receive adequate adjuvant anti-HER2 targeted therapy)

• In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm

• Grade I or grade II (biopsy)

• cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan)

• Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision)

• Interval since completion of local treatment of primary tumor \> 12 months

• Previous radiotherapy (whole breast or partial) of the ipsilateral breast

• Repeat breast conserving surgery feasible

• World Health Organization (WHO) performance ≤ 2

• Written informed consent

• The patient is legally competent

Locations
Other Locations
Netherlands
The Netherlands Cancer Institute
RECRUITING
Amsterdam
Contact Information
Primary
Tess Snellen, MD
t.snellen@nki.nl
0205129111
Backup
Lisa van den Hengel
l.vd.hengel@nki.nl
0205129111
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2027-04-11
Participants
Target number of participants: 31
Treatments
Experimental: Preoperative accelerated partial breast re-irradiation
Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov