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

Netherlands Cancer Institute (NKI)

Status

Enrolling

Conditions

Breast Cancer

Treatments

Procedure: Biopsy track removal

Radiation: Preoperative accelerated partial breast irradiation

Procedure: Breast conserving surgery

Procedure: Sentinel node procedure

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 or DCIS.

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 or DCIS.

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
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

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.