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

NCT ID: NCT06362616

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-12
• Study Completion Date: 2027-04-11

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Preoperative accelerated partial breast irradiation

Intervention Type: RADIATION

Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast

Breast conserving surgery

Intervention Type: PROCEDURE

Patients will be treated with breast conserving surgery.

Sentinel node procedure

Intervention Type: PROCEDURE

Patients will undergo a (repeat) sentinel node procedure.

Biopsy track removal

Intervention Type: PROCEDURE

The biopsy track will be surgically removed.

Interventions

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

Intervention Type: RADIATION

Breast conserving surgery

Patients will be treated with breast conserving surgery.

Intervention Type: PROCEDURE

Sentinel node procedure

Patients will undergo a (repeat) sentinel node procedure.

Intervention Type: PROCEDURE

Biopsy track removal

The biopsy track will be surgically removed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
• Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
• Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
• Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
• ER negative subtype
• Lymphovascular invasion in biopsy
• Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months)
• (Planned) oncoplastic surgery with major tissue displacement
• Participation in another clinical trial that interferes with the locoregional treatment of this protocol.
• It is expected that dosimetric constraints cannot be met, such as lung/heart constraints.
• Patients with proven BRCA-mutations

• Minimum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Haaglanden

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid Scholten, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

The Netherlands Cancer Institute

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Tess Snellen, MD

Role: CONTACT

t.snellen@nki.nl

0205129111 ext. 3448

Lisa van den Hengel

Role: CONTACT

l.vd.hengel@nki.nl

0205129111 ext. 9140

Facility Contacts

Astrid Scholten, MD PhD

Role: primary

a.scholten@nki.nl

+31205129111

Other Identifiers

N23PBD

Identifier Type: -

Identifier Source: org_study_id