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MRI-guided single dose preoperative radiotherapy in low-risk breast cancer

MRI-guided single dose preoperative radiotherapy in low-risk breast cancer - ABLATIVE-2

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46628
Enrollment
70
Registered
2018-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer mammary neoplasm

Interventions

MR-guided single dose preoperative radiotherapy of 20Gy to the tumor.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female, >

Exclusion criteria

Exclusion criteria: Indication for chemotherapy, lobular carcinoma, previous breast cancer, lymph node or distant metastasis, BRCA1, BRCA2 or CHEK2 gene mutation

Design outcomes

Primary

MeasureTime frame
Pathologic complete response.—

Secondary

MeasureTime frame
Radiologic response, relation between radiologic response and pathologic response, relation between pathology of biopsy and surgical specimen, toxicity, relation between immunoresponse and pathologic response, relation between circulation tumor DNA and pathologic response, cosmetic result, quality of life, workability or frailty (depending on age), disease free survival, overall survival.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)