Actively Recruiting
Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
Led by The Netherlands Cancer Institute · Updated on 2026-01-20
31
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
M
Medical Center Haaglanden
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 51 years or older
- Ipsilateral recurrent or second primary breast cancer or DCIS
- Histologically confirmed invasive adenocarcinoma (including with DCIS component) or DCIS alone with calcification on imaging
- Estrogen receptor positive and HER2neu negative tumor
- Tumor size 3 cm or less for invasive adenocarcinoma; affected area 2.5 cm or less for DCIS alone
- Grade I or II tumor based on biopsy
- No evidence of nodal or distant metastases (cN0M0) confirmed by axillary ultrasound and PET-CT if indicated
- Unifocal lesions on mammogram and MRI, with small satellite lesions allowed if suitable for local excision
- At least 12 months since completion of local treatment of primary tumor
- Previous radiotherapy of the ipsilateral breast
- Repeat breast conserving surgery is feasible
- WHO performance status 2 or less
- Written informed consent
- Legally competent to consent
You will not qualify if you...
- Grade 3 or higher radiotherapy toxicity in the breast after primary tumor treatment
- Previous boost radiotherapy, unless the current tumor is outside the original boost area
- Distant metastases or synchronous contralateral invasive or in situ carcinoma
- Invasive lobular carcinoma or pleiomorphic lobular carcinoma in situ
- Estrogen receptor negative tumor subtype
- Lymphovascular invasion found in biopsy
- Neoadjuvant systemic treatment for the current tumor, except presurgery hormonal therapy up to 2 months
- Planned oncoplastic surgery with major tissue displacement
- Participation in another clinical trial affecting locoregional treatment
- Expected inability to meet dosimetric constraints such as lung or heart limits
- Known BRCA gene mutation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Actively Recruiting
Research Team
T
Tess Snellen, MD
CONTACT
L
Lisa van den Hengel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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