Last updated: August 11, 2022
Sponsor: Institut Català d'Oncologia
Overall Status: Active - Recruiting
Phase
2
Condition
Breast Cancer
Cancer
Treatment
N/AClinical Study ID
NCT05498311
IORT BREAST CANCER
Ages > 45 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility forconservative surgery (with or without oncoplastic surgery) and radiotherapy.
- Not pregnant at diagnosis.
- Signed informed consent form.
- Age ≥45 years old.
- Patients candidates to Intrabeam.
- Patients with ≥60 years with the presence of one or more of the following adversecriteria after surgery:
- Tumor size > 2.5 cm.
- Extensive intraductal carcinoma (≥25%)
- Lymphovascular invasion.
- Involved focal margins (<2mm) without ampliation surgery.
Exclusion
Exclusion Criteria:
- Presence of distant metastasis.
- Primary chemotherapy.
- Lymph node involvement.
- Negative hormonal receptors.
- Diagnosis of any other infiltrating tumour except for adequately resected squamous orbasal cell epitheliomas
- Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma,dermatomyositis).
- Uncontrolled infection.
- Concurrent treatment with other experimental treatments
- Lack of signed informed consent form.
Study Design
Total Participants: 89
Study Start date:
October 20, 2016
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Evelyn Martínez
Hospitalet de Llobregat, Barcelona 08908
SpainActive - Recruiting
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