Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Pathologic Complete Response

Breast Diseases

Skin Diseases

Quality of Life

Patients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation

Single dose ablative radiotherapy

Yasmin Civil, MD

Desirée van den Bongard, MD, PhD

In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.

Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.

Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

pCR is defined as the absence of residual invasive cancer on resected breast specimen

Radiologic complete response (rCR) is defined as complete absence of pathologic contrast enhancement in the original tumor bed and complete absence of pathologic ADC (apparent diffusion coefficient) reduction in the original tumor bed. rCR is reported according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0

PROMs are assessed using the European Organization for Research and Treatment of Cancer core-30 quality of life questionnaire (EORTC QLQ-C30)

PROMs are assessed using the European Organization for Research and Treatment of Cancer breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23)

PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire

Cosmetic outcome is assessed by the physician using a questionnaire

Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. .

Cosmetic outcome is assessed objectively using images captured using the VECTRA XT 3D-imaging system. This three-dimensional surface-imaging system uses stereophotogrammetry to estimate x, y, z coordinates of the imaged surface. These coordinates will be used to calculate the volume-shape-symmetry measure.

A local recurrence is defined as disease occurrence in the ipsilateral breast. A regional recurrence is defined as nodal occurrence in the ipsilateral axilla, internal mammary, infraclavicular or supraclavicular region. A distant metastasis defined as disease occurrence in the contralateral breast or contralateral breast nodal region or another organ than breast involvement.

Overall survival will be calculated from the date of the radiotherapy treatment until the time of breast-cancer related death or breast-cancer unrelated death.

Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery.

ctDNA will be assessed in blood samples taken between radiotherapy and surgery.

Dutch Cancer Society

Amsterdam UMC, location VUmc

MD, PhD

Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria

A single dose ablative radiotherapy will be delivered prior to surgery

HJGD van den Bongard, MD, PhD

The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.

A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.

This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.

Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer

Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients

Future research proposal performed within 10 years after radiotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients	NCT05350722	Breast Cancer	Single dose abl...	50 Years -	Amsterdam UMC, location VUmc
Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer	NCT02316561	Breast Neoplasm	Single dose abl...	50 Years -	UMC Utrecht
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients	NCT05350722	Breast Cancer	Single dose abl...	50 Years -	Amsterdam UMC, location VUmc
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients	NCT05350722	Breast Cancer	Single dose abl...	50 Years -	Amsterdam UMC, location VUmc

Spots Global Cancer Trial Database for single dose ablative radiotherapy