Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer (PAPBI-3)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Preoperative accelerated partial breast irradiation; Procedure: Breast conserving surgery; Procedure: Sentinel node procedure; Procedure: Biopsy track removal

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.

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tess Snellen, MD; Phone Number: 3448 0205129111; Email: t.snellen@nki.nl
• Study Contact Backup: Name: Lisa van den Hengel; Phone Number: 9140 0205129111; Email: l.vd.hengel@nki.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Recruiting
    • The Netherlands Cancer Institute
    • Contact: Astrid Scholten, MD PhD; Phone Number: +31205129111; Email: a.scholten@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute post-treatment toxicity	Acute post-treatment toxicity from start of local treatment up to 3 months after end of local treatment, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. At least grade ≥ 2 toxicity is scored as an event.	3,5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibrosis/induration	Assessment of fibrosis/induration grade at 3 months after end of local treatment, assessed the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value.	3 months
Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30	PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.	3,5 months
Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23	PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.	3,5 months
Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis	PROMs will be assessed using the Patient's Questionnaire Cosmesis, adapted from Sneeuw et al. (1992). Patients score their cosmetic outcome by the following outcomes: very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.	3,5 months
Cosmetic outcome according to the BCCT.core software program	Cosmetic outcome according to the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software program. The program returns an overall cosmetic outcome score (excellent, good, fair, or poor) based on the symmetry of the breasts, skin color, and scar visibility.	3,5 months

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Erasmus Medical Center; Medical Center Haaglanden
• Investigators: Principal Investigator: Astrid Scholten, MD PhD, The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): April 11, 2027

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Preoperative; Recurrent breast cancer; Partial breast irradiation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Surgical Procedures, Operative; Mastectomy; Mastectomy, Segmental
• Other Study ID Numbers: N23PBD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No