Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия Preoperative accelerated partial breast irradiation
  Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast
• Процедура Breast conserving surgery
  Patients will be treated with breast conserving surgery.
• Процедура Sentinel node procedure
  Patients will undergo a (repeat) sentinel node procedure.
• Процедура Biopsy track removal
  The biopsy track will be surgically removed.

Первичные конечные точки

• Acute post-treatment toxicity [Срок оценки: 3,5 months]

Вторичные конечные точки (5)

• Fibrosis/induration [Срок оценки: 3 months]
• Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30 [Срок оценки: 3,5 months]
• Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23 [Срок оценки: 3,5 months]
• Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis [Срок оценки: 3,5 months]
• Cosmetic outcome according to the BCCT.core software program [Срок оценки: 3,5 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• ≥ 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• The Netherlands Cancer Institute — Amsterdam

Идентификаторы

NCT: NCT06362616 · N23PBD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗