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

NCT06362616 | Recruiting

• 1 other identifier: N23PBD
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Recurrent breast cancer; Preoperative; Partial breast irradiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fibrosis/induration

  3 months

• Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30

  3,5 months

• Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23

  3,5 months

• Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis

  3,5 months

• Cosmetic outcome according to the BCCT.core software program

  3,5 months

Study Arms (1)

Preoperative accelerated partial breast re-irradiation

EXPERIMENTAL

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; Procedure: Breast conserving surgery; Procedure: Sentinel node procedure; Procedure: Biopsy track removal

Interventions

Preoperative accelerated partial breast irradiation 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

Preoperative accelerated partial breast re-irradiation

Breast conserving surgery PROCEDURE

Patients will be treated with breast conserving surgery.

Preoperative accelerated partial breast re-irradiation

Sentinel node procedure PROCEDURE

Patients will undergo a (repeat) sentinel node procedure.

Preoperative accelerated partial breast re-irradiation

Biopsy track removal PROCEDURE

The biopsy track will be surgically removed.

Preoperative accelerated partial breast re-irradiation

Eligibility Criteria

• Age: 51 Years+
• Gender Eligibility Details: Patients who were born as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ≥ 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Medical Center Haaglanden: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

The Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Astrid Scholten, MD PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tess Snellen, MD

CONTACT

0205129111; t.snellen@nki.nl

Lisa van den Hengel

CONTACT

0205129111; l.vd.hengel@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 12, 2024
• Study Start: April 12, 2024
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): April 11, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

NL (1)