Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preoperative accelerated partial breast irradiation, Breast conserving surgery, Sentinel node procedure, Biopsy track removal.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 51 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Acute post-treatment toxicity [Time frame: 3,5 months]
Secondary outcome measures (5)
- Fibrosis/induration [Time frame: 3 months]
- Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30 [Time frame: 3,5 months]
- Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23 [Time frame: 3,5 months]
- Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis [Time frame: 3,5 months]
- Cosmetic outcome according to the BCCT.core software program [Time frame: 3,5 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- The Netherlands Cancer Institute — Amsterdam
Identifiers
NCT: NCT06362616 · N23PBD