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

Netherlands Cancer Institute (NKI) logo

Netherlands Cancer Institute (NKI)

Status

Enrolling

Conditions

Breast Cancer

Treatments

Procedure: Biopsy track removal
Procedure: Sentinel node procedure
Radiation: Preoperative accelerated partial breast irradiation
Procedure: Breast conserving surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06362616
N23PBD

Details and patient eligibility

About

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.

Full 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. Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.

Enrollment

31 estimated patients

Sex

Female

Ages

51+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female patients ≥ 51 years
  • Ipsilateral breast cancer; recurrence or second primary
  • Histologically proven invasive adenocarcinoma (invasive adenocarcinoma with ductal carcinoma in situ (DCIS) component is also accepted)
  • Histologically proven estrogen receptor positive, HER2neu-negative
  • Tumor size ≤ 3 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)
  • DCIS only, i.e. no invasive carcinoma present
  • Triple negative or HER2-positive 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

Preoperative accelerated partial breast re-irradiation
Experimental group
Description:
Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery
Treatment:
Procedure: Breast conserving surgery
Radiation: Preoperative accelerated partial breast irradiation
Procedure: Sentinel node procedure
Procedure: Biopsy track removal

Trial contacts and locations

1

Loading...

Central trial contact

Lisa van den Hengel; Tess Snellen, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems