To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorFondazione Sandro Pitigliani
About this trial
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.
Eligibility criteria
Qualifiers
Women aged 18 years or older, with a diagnosis of metastatic breast cancer
ER-positive and HER2-negative disease as assessed locally either on primary tumor tissue or on a biopsy of a metastasis
The patient has not received any prior systemic therapy for metastatic breast cancer (may have received prior hormonal therapy or chemotherapy in the neo/adjuvant setting)
The patient is candidate to receive first-line therapy with an aromatase inhibitor (AI) and a CDK4/6 inhibitor per local clinical practice
Disqualifiers
Patients with metastatic disease isolated to the central nervous system (CNS) without metastatic involvement of any other site, unless surgical excision of CNS metastasis has been performed and the tumor tissue is available for the study.
Previous or current non-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix and/or adequately treated basal cell or squamous cell carcinoma of the skin
Trial design
Treatments tested in this trial
- Thymidine kinase activity
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Fondazione Sandro Pitigliani
Lead sponsor
Clinical Research Technology S.r.l.
Collaborator
Source ClinicalTrials.gov