Liquid biopsy and imaging in Breast Cancer - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Breast Cancer

Intervention / Treatment

Diagnostic test: Liquid biopsy and imaging

Detailed Description

This is a single arm prospective, monocentric, open, experimental pilot study. The response to NAC in breast cancer is extremely heterogeneous. The study and the identification of factors that can predict the response to treatment is therefore a priority, constituting a relevant "clinical unmet need".Modern molecular biology techniques as well as imaging diagnostics could be valuable tools for characterizing the response to NAC toward the definition of more personalized therapies.The prediction of therapy response after two cycle of chemotherapy rather than at the end of six cycles using non-invasive procedures will spare unwanted toxicity to the patients and resources to the Regional and National Health system. This study will also provide the patients, their familiar and all the stakeholders involved in the cure of Breast Cancer new important information regarding the management of breast cancer patients.This is a non-interventional study; therefore, the treatment will be as per physician choice according to the most appropriate therapeutic opportunities available for each patients' based on the type and stage of disease and the patients' performance status.Currently, the NAC regimens commonly used at CRO-Aviano for NAC are Epirubicine 90 mg/mq + Ciclophosphamide 600 mg/mq d1 q21 or q14 (EC)(dose dense) followed by weekly Paclitaxel 80 mg/mq for a total of 12 administrations. Occasionally, due to patients and tumor features only weekly Paclitaxel is used, and usually in this case up to 24 administrations may be given. Only in the case of HER2 positive BC trastuzumab 2 mg/kg is added to weekly Paclitaxel. Given the low response rate of hormone-based neoadjuvant therapy, only in rare cases (e.g. patients not amenable of surgery due to comorbidities), this approach is used.

Study Type

Observational

Enrollment (Anticipated)

40

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: Milena Nicoloso, MD
Phone Number: +39 0434659119
Email: mnicoloso@cro.it

Study Contact Backup

Name: Silvia Bolzonello, MD
Phone Number: +39 0434659255
Email: silvia.bolzonello@cro.it

Study Locations

Italy
- Pordenone
  - Aviano, Pordenone, Italy, 33081
    - Recruiting
    - Centro di Riferimento Oncologico
    - Contact:
      
      Milena Nicoloso, MD
      
      Phone Number: +39 0434659119
      
      Email: mnicoloso@cro.it
    - Contact:
      
      Silvia Bolzonello, MD
      
      Phone Number: +39 0434659255
      
      Email: silvia.bolzonello@cro.it

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

No

Sampling Method

Non-Probability Sample

Study Population

Patient with Histological Diagnosis of Infiltrating Breast Cancer

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

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
Identification of novel micro-invasive predictors of pathological complete response (pCR) during neo-adjuvant therapy. Time Frame: from start of therapy until first documented progression, assessed up to 12 months	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. Time Frame: from start of therapy until first documented progression, assessed up to 12 months	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Time Frame: from start of therapy until first documented progression, assessed up to 12 months	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; Time Frame: from start of therapy until first documented progression, assessed up to 12 months	Determine if the basal Metabolomics 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 SERS spectra and/or its variation after two cycle of therapy will predict the pCR of breast cancer patients treated with neo-adjuvant therapy; Time Frame: 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; Time Frame: 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; Time Frame: from start of therapy until first documented progression, assessed up to 12 months	Determine if a variation in T cell sub-populations 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
Evaluate over time Relapse Free Survival (RFS) and correlate with micro-invasive parameters from primary and/or secondary objectives. Time Frame: from start of therapy until first documented relapse, assessed up to 12 months	Evaluate over time Relapse Free Survival (RFS) and correlate with micro-invasive parameters from primary and/or secondary objectives.	from start of therapy until first documented relapse, assessed up to 12 months

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: Milena Nicoloso, MD, Centro di Riferimento Oncologico - Aviano

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)

June 20, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

February 24, 2025

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Estimate)

May 8, 2023

Study Record Updates

Last Update Posted (Estimate)