Clinical Trial on Breast Cancer - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Breast Cancer

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 toxicity profile is of primary importance in order to guarantee a satisfactory quality of life. Currently there are numerous predictive models of toxicity (Normal Tissue Complication Probability, NTCP) which are based on dosimetric and sometimes also clinical data. To date, they do not include individual genetic variability. However, it is believed that inter-individual variability may be responsible for up to 40% of actinic toxicity. Multiparametric models that consider genetics, dose and clinical aspects probably better reflect the complexity of radiotoxicity than models that rely on a single parameter and it is possible to integrate such parameters using a machine learning approach. The definition of the molecular and genetic variables related to radiotoxicity and their integration into predictive molecular signatures would therefore allow the risk 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.

Study Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lorenzo Vinante, MD
Phone Number: +390434659855
Email: lorenzo.vinante@cro.it

Study Locations

Italy
- Pordenone
  - Aviano, Pordenone, Italy, 33081
    - Recruiting
    - Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
    - Contact:
      
      Lorenzo Vinante, MD
      
      Phone Number: +390434659855
      
      Email: lorenzo.vinante@cro.it
    - Principal Investigator:
      
      Lorenzo Vinante, MD
    - Principal Investigator:
      
      Barbara Belletti, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women with distant non-metastatic breast cancer candidated to radiotherapy after conservative surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generation of a predictive model for actinic fibrosis. Time Frame: up to 2 years after start of treatment	Identification of a predictive model of actinic fibrosis in the breast, with sensitivity of at least 75% and specificity of 90%. Fibrosis is defined as grade ≥2 (CTCAE v 4.0) or skin induration as grade ≥2 defined according to CTCAE v 4.0 .	up to 2 years after start of treatment

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

Principal Investigator: Lorenzo Vinante, MD, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
Principal Investigator: Barbara Belletti, PhD, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria