Actively Recruiting
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
Led by Fondazione Sandro Pitigliani · Updated on 2025-02-26
150
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
Sponsors
F
Fondazione Sandro Pitigliani
Lead Sponsor
C
Clinical Research Technology S.r.l.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor as per standard clinical practice. Blood and tissue samples will be collected for biomarker analysis, including thymidine kinase1 activity, gene expression signatures and circulating tumor DNA.
CONDITIONS
Official Title
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older with metastatic breast cancer
- Estrogen receptor-positive and HER2-negative disease confirmed on primary tumor or metastatic biopsy
- No prior systemic therapy for metastatic breast cancer (prior hormonal or chemotherapy in neo/adjuvant setting allowed)
- Candidate for first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor per local practice
- Evaluable disease according to RECIST 1.1 (measurable or non-measurable disease)
- Provide a formalin-fixed, paraffin-embedded tumor block from a metastatic biopsy before study entry (bone-only disease patients may join without metastatic biopsy)
- Agree to provide blood samples at specified study time points
You will not qualify if you...
- Metastatic disease limited only to the central nervous system without other metastatic sites, unless CNS metastasis has been surgically removed and tumor tissue is available
- History of non-breast cancers within the last 5 years except for in situ cervical carcinoma or treated basal or squamous cell skin cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Santo Stefano
Prato, Tuscany, Italy, 59100
Actively Recruiting
Research Team
L
Luca Malorni
CONTACT
C
Chiara Biagioni
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here