Status:
WITHDRAWN
Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy
Lead Sponsor:
Karolinska Institutet
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In clinically node-positive (cN+) breast cancer, preoperative systemic therapy (PST) is common. With increasing rates of complete tumour eradication, there is a need for de-escalation of locoregional ...
Eligibility Criteria
Inclusion
- Patients with primary invasive breast cancer cT1-cT3
- cN1 status prior to PST
- Cytological or histological proof of axillary metastasis before PST
- Full tumour biology available before initiation of PST
- Oral and written consent
- Age ≥ 18 years
Exclusion
- Biopsy-confirmed regional nodal metastases outside of the ipsilateral axilla
- Distant metastases at diagnosis
- Inflammatory breast cancer
- Previous axillary surgery
- Previous radiotherapy to ipsilateral breast, chest or axilla
- History of prior invasive breast cancer
- Ongoing pregnancy or breast-feeding
- Bilateral invasive breast cancer
- Medical contraindication for radiotherapy or inability to receive recommended radiotherapy
- Medical contraindication for adjuvant endocrine treatment, if indicated
- Inability to absorb or understand the meaning of the study
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04281355
Start Date
January 1 2021
End Date
December 31 2029
Last Update
February 25 2021
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