A Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)
An Observational Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)
Centro di Riferimento Oncologico - Aviano
420 participants
Aug 25, 2022
OBSERVATIONAL
Conditions
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 toxicity profile is of primary importance in order to guarantee a satisfactory quality of life. The definition of the molecular and genetic variables related to radiotoxicity and their integration into predictive molecular signatures may allow the risk of toxicity to be individualized. This would provide the clinician with a useful tool in order to personalize the radiation treatment, thus being able to choose the best technique or schedule for each patient.
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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.
Locations(1)
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NCT06114589