RecruitingNot ApplicableNCT05350722

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

Sponsor

Amsterdam UMC, location VUmc

Enrollment

100 participants

Start Date

Aug 24, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 50 Years

Inclusion Criteria12

WHO performance scale ≤2.
Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.
Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
Tumor size as assessed on MRI.
On tumor biopsy:
Bloom-Richardson grade 1 or 2.
Non-lobular invasive histological type carcinoma.
LCIS or (non-extensive) DCIS is accepted.
ER positive tumor receptor.
HER2 negative tumor.
Tumor-negative sentinel node (excluding isolated tumor cells).
Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria13

Legal incapacity.
BRCA1, BRCA2 or CHEK2 gene mutation.
Distant metastasis.
Previous history of breast cancer or DCIS.
Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
Collagen synthesis disease.
Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).
Invasive lobular carcinoma.
MRI absolute contraindications as defined by the Department of Radiology.
Nodal involvement with cytological or histological confirmation.
Indication for treatment with (neo-)adjuvant chemotherapy.
Non-feasible dosimetric RT plan.

Interventions

RADIATIONSingle dose ablative radiotherapy

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