Status:
RECRUITING
A Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)
Lead Sponsor:
Centro di Riferimento Oncologico - Aviano
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Breast radiation treatment is burdened by acute and chronic toxicities, in most cases mild. However, considering the excellent life expectancy of patients with breast cancer, maintaining a low toxicit...
Detailed Description
Breast radiation treatment is burdened by acute and chronic toxicities, in most cases mild. However, considering the excellent life expectancy of patients with breast cancer, maintaining a low toxicit...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Ability to express appropriate informed consent to treatment;
- Distant nonmetastatic breast cancer;
- Histology: infiltrating NST(no special type)/lobular carcinoma or ductal carcinoma in situ;
- Stage: pTis; pT1-3 pN1-3 M0;
- Hormone receptors, HER-2 status: Any;
- Breast-conserving surgery. Both the sentinel lymph node biopsy and axillary lymphadenectomy. Negative surgical margins.
- Candidates for postoperative radiation treatment.
Exclusion
- Refusal of radiotherapy treatment (i.e., absence of signed informed consent);
- Previous radiation therapy at the same site;
- Concomitant chemotherapy with anthracyclines or taxanes;
- Inability to maintain treatment position;
- Partial breast radiotherapy (PBI);
- Male breast cancer;
- Mastectomy surgery.
Key Trial Info
Start Date :
August 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06114589
Start Date
August 25 2022
End Date
June 30 2026
Last Update
November 7 2023
Active Locations (1)
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1
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Aviano, Pordenone, Italy, 33081