Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer (ABLATIVE)

UMC Utrecht

Status

Completed

Conditions

Breast Neoplasm

Treatments

Radiation: Single dose ablative radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02316561

NL46017.041.13

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

WHO performance scale ≤2.
Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:
- Tumor size as assessed on MRI
On tumor biopsy:
- Non-lobular invasive histological type carcinoma.
- LCIS is accepted.
- ER positive tumor receptor.
Tumor negative sentinel node.
Adequate communication and understanding skills of the Dutch language.

Exclusion criteria

Legal incapacity
Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible)
BRCA gene mutation.
Previous history of breast cancer
Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion
Her2neu positive tumor.
Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist.
Collagen synthesis disease.
Signs of extensive DCIS component on histological biopsy or mammogram.
Invasive lobular carcinoma.
MRI absolute contraindications as defined by the Radiology Department.
Nodal involvement with cytological or histological confirmation.
Treatment with neo-adjuvant systemic therapy.