Clinical trial NCT06362616: Preoperative Accelerated Partial Breast Irradiation in Patients with Locally Recurrent or Second Primary Breast Cancer
Official title: Preoperative Accelerated Partial Breast Irradiation in Patients with Locally Recurrent or Second Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Recurrent breast cancer
Preoperative
Partial breast irradiation
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 31
Sex: FEMALE
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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 or HER2neu positive (the latter should also receive adequate adjuvant anti-HER2 targeted therapy)
* 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.

Primary outcomes:
measure: Acute post-treatment toxicity
timeFrame: 3,5 months
Secondary outcomes:
measure: Fibrosis/induration
timeFrame: 3 months
measure: Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30
timeFrame: 3,5 months
measure: Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23
timeFrame: 3,5 months
measure: Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis
timeFrame: 3,5 months
measure: Cosmetic outcome according to the BCCT.core software program
timeFrame: 3,5 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
Study officials:
affiliation: The Netherlands Cancer Institute
name: Astrid Scholten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: