Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy

NCT05846997 | Unknown

• 1 other identifier: CRO-2018-10
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is the identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.

  1\. Determine if a PET SUV decrease ≥ 50% after two cycles of therapy respect to the basal value will predict the pCR predict the pCR of breast cancer patients treated with neo-adjuvant therapy;

  from start of therapy until first documented progression, assessed up to 12 months

• Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy.

  2\. Determine if a cfDNA variation ≥ 25% of the basal value after two cycles of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy

  from start of therapy until first documented progression, assessed up to 12 months

Secondary Outcomes (6)

• Determine if the basal number of CTC and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;

  from start of therapy until first documented progression, assessed up to 12 months

• Determine if the basal SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy pCR of breast cancer patients treated with neo-adjuvant therapy;

  from start of therapy until first documented progression, assessed up to 12 months

• Determine if the basal SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;

  from start of therapy until first documented progression, assessed up to 12 months

• Determine if the basal Cytokines serum levels and/or their variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;

  from start of therapy until first documented progression, assessed up to 12 months

• Determine if a the basal Immune proficiency will predict the pCR of breast cancer patients treated with neo-adjuvant therapy;

  from start of therapy until first documented progression, assessed up to 12 months

Interventions

Liquid biopsy and imaging DIAGNOSTIC_TEST

Liquid biopsy and imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Histological Diagnosis of Infiltrating Breast Cancer

You may qualify if:

• Age ≥ 18 years
• Histological Diagnosis of Infiltrating Breast Cancer.
• The presence of measurable mammary lesions;
• The presence of metabolically active mammary lesions;
• Performance Status (Eastern Cooperative Oncology Group scale, ECOG) ≤ 1;
• Compliance with periodic blood withdrawal;
• Compliance with periodic PET/CT and RMN imaging;
• Adequate clinical and laboratory test results for undertaking neoadjuvant chemotherapy and surgery;
• Written informed consent.

You may not qualify if:

• The presence of contraindications for the execution of RMN and PET-TC;
• Presence of metastatic disease;
• Pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma of the skin;
• Uncontrolled active infections;
• Insufficient patient compliance;
• Absence of signed informed consent

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Liquid Biopsy; Diagnostic Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Milena Nicoloso, MD

  Centro di Riferimento Oncologico - Aviano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milena Nicoloso, MD

CONTACT

+39 0434659119; mnicoloso@cro.it

Silvia Bolzonello, MD

CONTACT

+39 0434659255; silvia.bolzonello@cro.it

Study Design

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

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 6, 2023
• Study Start: June 20, 2018
• Primary Completion: December 31, 2023
• Study Completion: February 24, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

IT (1)