Actively Recruiting
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Led by Amsterdam UMC, location VUmc · Updated on 2024-12-30
100
Participants Needed
7
Research Sites
796 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients at least 50 years old
- WHO performance scale 2 or less
- Diagnosed with unifocal cT1N0 breast cancer confirmed by mammography, ultrasound, and MRI
- No indication for chemotherapy or HER2-targeted therapy according to guidelines
- Indication for endocrine therapy is allowed
- Tumor size assessed by MRI
- Tumor biopsy showing Bloom-Richardson grade 1 or 2
- Non-lobular invasive histological carcinoma type
- Presence of LCIS or non-extensive DCIS is accepted
- Estrogen receptor (ER) positive tumor
- HER2 negative tumor
- Tumor-negative sentinel lymph node (excluding isolated tumor cells)
- Adequate communication and understanding of Dutch language
You will not qualify if you...
- Legal incapacity
- Presence of BRCA1, BRCA2, or CHEK2 gene mutation
- Distant metastasis
- Previous history of breast cancer or DCIS
- Other malignancy within 5 years before breast cancer diagnosis (except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin)
- Collagen synthesis disease
- Signs of extensive DCIS on biopsy or imaging
- Invasive lobular carcinoma
- Absolute MRI contraindications
- Nodal involvement confirmed cytologically or histologically
- Indication for (neo-)adjuvant chemotherapy
- Non-feasible radiotherapy dosimetric plan
AI-Screening
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Trial Site Locations
Total: 7 locations
1
GenesisCare
Sydney, Australia
Not Yet Recruiting
2
Flevoziekenhuis
Almere Stad, Netherlands
Actively Recruiting
3
Ziekenhuis Amstelland
Amstelveen, Netherlands
Actively Recruiting
4
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
5
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Actively Recruiting
6
Radboud UMC
Nijmegen, Netherlands
Actively Recruiting
7
Zaans Medisch Centrum
Zaandam, Netherlands
Actively Recruiting
Research Team
Y
Yasmin Civil, MD
CONTACT
D
Desirée van den Bongard, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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