Developing predictive models for breast cancer radiation toxicity
An Observational Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)
This study is trying to find out how certain genes and factors can help predict and reduce side effects from radiation treatment in breast cancer patients to improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT06114589 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify molecular and genetic factors associated with radiation-induced toxicity in breast cancer patients. By integrating these factors into predictive models, the study seeks to personalize radiation treatment plans, thereby minimizing toxicity and improving quality of life. The approach utilizes machine learning to analyze genetic variability alongside clinical and dosimetric data, potentially leading to more effective treatment strategies. The ultimate goal is to provide clinicians with tools to tailor radiation therapy to individual patient needs.
Who should consider this trial
Good fit: Ideal candidates include adult patients (18 years and older) with nonmetastatic breast cancer who are scheduled for postoperative radiation treatment.
Not a fit: Patients who have previously received radiation therapy at the same site or those undergoing mastectomy surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce radiation-related toxicities for breast cancer patients, enhancing their quality of life.
How similar studies have performed: While there are existing predictive models for radiation toxicity, this study's integration of genetic factors into these models represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Aviano, Pordenone
- Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano, Pordenone, Italy (Recruiting)
Study contacts
- Principal investigator: Lorenzo Vinante, MD — Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
- Study coordinator: Lorenzo Vinante, MD
- Email: lorenzo.vinante@cro.it
- Phone: +390434659855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.