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NCT06362616
Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
Conditions: Breast Cancer
Sex: Female
Ages: 51 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 31
Sponsor: The Netherlands Cancer Institute
Location: The Netherlands Cancer Institute Amsterdam
Summary
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.
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
Source: ClinicalTrials.gov (NCT06362616). StuddyBuddy aggregates publicly available trial information.