A Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)

NCT06114589 | Recruiting

• 1 other identifier: CRO-2022-29
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Generation of a predictive model for actinic fibrosis.

  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 Outcomes (23)

• Generation of a predictive model for acute skin toxicity

  up to 2 years after start of treatment

• Generation of a predictive model for late skin toxicity

  up to 2 years after start of treatment

• Generation of a predictive model for acute pain

  up to 2 years after start of treatment

• Generation of a predictive model for chronic pain

  up to 2 years after start of treatment

• Generation of a predictive model for fatigue

  up to 2 years after start of treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lorenzo Vinante, MD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

• Barbara Belletti, PhD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Vinante, MD

CONTACT

+390434659855; lorenzo.vinante@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: August 25, 2022
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

IT (1)