Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients (ABLATIVE-2)

  • STATUS
    Recruiting
  • End date
    Mar 14, 2035
  • participants needed
    100
  • sponsor
    Amsterdam UMC, location VUmc
Updated on 14 October 2022
carcinoma
endocrine therapy
hormone therapy
tumor cells
HER2
erbb2
sentinel node
mammogram

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.

Description

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.

Details
Condition Breast Cancer
Treatment Single dose ablative radiotherapy
Clinical Study IdentifierNCT05350722
SponsorAmsterdam UMC, location VUmc
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

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