Status:
WITHDRAWN
MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer
Lead Sponsor:
UMC Utrecht
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect dat...
Detailed Description
In this multi-center single arm interventional cohort study 70 patients will be treated with single dose preoperative partial breast irradiation (PBI). Breast conserving surgery will be performed 12 m...
Eligibility Criteria
Inclusion
- 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 unifocal cT1-2(maximum 3 cm)N0 breast cancer on mammography, ultrasound and MRI.
- Patients with an indication for chemotherapy or immunotherapy 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.
- Adequate communication and understanding skills of the Dutch language.
Exclusion
- Legal incapacity.
- BRCA1, BRCA2 or CHEK2 gene mutation.
- 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 imaging.
- 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.
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2031
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03863301
Start Date
March 4 2019
End Date
November 1 2031
Last Update
February 26 2021
Active Locations (1)
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1
UMC Utrecht
Utrecht, Netherlands