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Trial Title:
Use of INnovative and Micro-INvasive TEchniques for the Early Identification of Breast Cancer Patients Benefitting From Neo-adjuvant Therapy
NCT ID:
NCT05846997
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Liquid biopsy and imaging
Description:
Liquid biopsy and imaging
Summary:
The purpose of the study is the identification of novel micro-invasive predictors of
pathological complete response (pCR) during neo-adjuvant therapy
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.
Criteria for eligibility:
Study pop:
Patient with Histological Diagnosis of Infiltrating Breast Cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Histological Diagnosis of Infiltrating Breast Cancer.
3. The presence of measurable mammary lesions;
4. The presence of metabolically active mammary lesions;
5. Performance Status (Eastern Cooperative Oncology Group scale, ECOG) ≤ 1;
6. Compliance with periodic blood withdrawal;
7. Compliance with periodic PET/CT and RMN imaging;
8. Adequate clinical and laboratory test results for undertaking neoadjuvant
chemotherapy and surgery;
9. Written informed consent.
Exclusion Criteria:
1. The presence of contraindications for the execution of RMN and PET-TC;
2. Presence of metastatic disease;
3. Pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma
of the skin;
4. Uncontrolled active infections;
5. Insufficient patient compliance;
6. Absence of signed informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Milena Nicoloso, MD
Phone:
+39 0434659119
Email:
mnicoloso@cro.it
Contact backup:
Last name:
Silvia Bolzonello, MD
Phone:
+39 0434659255
Email:
silvia.bolzonello@cro.it
Start date:
June 20, 2018
Completion date:
February 24, 2025
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05846997
