Status:
RECRUITING
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief 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 ...
Detailed 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 respo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2037
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05350722
Start Date
August 24 2022
End Date
December 1 2037
Last Update
December 30 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
GenesisCare
Sydney, Australia
2
Flevoziekenhuis
Almere Stad, Netherlands
3
Ziekenhuis Amstelland
Amstelveen, Netherlands
4
Amsterdam UMC
Amsterdam, Netherlands