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

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

NCT ID: NCT06362616

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Recurrent breast cancer
Preoperative
Partial breast irradiation

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Preoperative accelerated partial breast irradiation
Description: Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast
Arm group label: Preoperative accelerated partial breast re-irradiation

Intervention type: Procedure
Intervention name: Breast conserving surgery
Description: Patients will be treated with breast conserving surgery.
Arm group label: Preoperative accelerated partial breast re-irradiation

Intervention type: Procedure
Intervention name: Sentinel node procedure
Description: Patients will undergo a (repeat) sentinel node procedure.
Arm group label: Preoperative accelerated partial breast re-irradiation

Intervention type: Procedure
Intervention name: Biopsy track removal
Description: The biopsy track will be surgically removed.
Arm group label: Preoperative accelerated partial breast re-irradiation

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.

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. Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Female patients ≥ 51 years - Ipsilateral breast cancer; recurrence or second primary - Histologically proven invasive adenocarcinoma (invasive adenocarcinoma with ductal carcinoma in situ (DCIS) component is also accepted) - Histologically proven estrogen receptor positive, HER2neu-negative - Tumor size ≤ 3 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) - DCIS only, i.e. no invasive carcinoma present - Triple negative or HER2-positive 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.

Gender: Female

Gender based: Yes

Gender description: Patients who were born as female

Minimum age: 51 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Netherlands Cancer Institute

Address:
City: Amsterdam
Zip: 1066CX
Country: Netherlands

Status: Recruiting

Contact:
Last name: Astrid Scholten, MD PhD

Phone: +31205129111
Email: a.scholten@nki.nl

Start date: April 12, 2024

Completion date: April 11, 2027

Lead sponsor:
Agency: The Netherlands Cancer Institute
Agency class: Other

Source: The Netherlands Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06362616