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PAPBI-3

Preoperative Accelerated Partial Breast Irradiation in patients with locally recurrent or second primary breast cancer - PAPBI-3

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56628
Enrollment
31
Registered
2023-12-15
Start date
2024-10-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ipsilateral recidive or second primary mammacarcinoma Recurrent breast cancer or second new tumor in the same breast

Interventions

The intervention involves preoperative accelerated partial re-irradiaton&nbsp
followed by repeat breast conserving surgery.

Sponsors

Antoni van Leeuwenhoek (AVL)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 • 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

Exclusion criteria: • >= grade 3 radiotherapy toxicity in the breast  • Distant metastases and/or synchronous contralateral invasive or in situ  carcinoma • Lobular invasive carcinoma or pleiomorph LCIS • ER negative subtype • Lymphovascular invasion in biopsy • Neoadjuvant systemic treatment for the protocol tumor (except for admission  of pre-surgery hormonal therapy <= 2 months) • (Planned) oncoplastic surgery with major tissue displacement• BRCA mutations

Design outcomes

Primary

MeasureTime frame
Acute post-treatment toxicity up to 3 months after end of local treatment, assessed by the CTCAE v5.0.

Secondary

MeasureTime frame
• Fibrosis/induration • Quality of life • Cosmetic outcome according to the BCCT.core software program

Countries

Netherlands

Contacts

Public ContactA. Scholten

Antoni van Leeuwenhoek (AVL)

a.scholten@nki.nl0205129111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026