NL-OMON56628Not yet recruitingPhase 2
Preoperative Accelerated Partial Breast Irradiation in patients with locally recurrent or second primary breast cancer - PAPBI-3
Antoni van Leeuwenhoek Ziekenhuis0 sites31 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 31
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Female patients >= 51 years
- •Ipsilateral breast cancer; recurrence or second primary
- •Histologically proven invasive adenocarcinoma
- •Histologically proven estrogen receptor positive, HER2-negative
- •Tumor size <= 3 cm
- •Grade I or grade II (biopsy)
- •Unifocal lesions on mammogram and MRI
- •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
Exclusion Criteria
- •>= grade 3 radiotherapy toxicity in the breast
- •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
- •Lobular invasive carcinoma or pleiomorph LCIS
- •Pure DCIS
- •Triple negative or HER2neu positive subtype
- •Lymphovascular invasion in biopsy
- •Neoadjuvant systemic treatment for the protocol tumor (except for admission
- •of pre-surgery hormonal therapy <= 2 months)
Investigators
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