An observational study in Metastatic Breast Cancer, ER Positive Breast Cancer and HER2-negative Breast Cancer, sponsored by Fondazione Sandro Pitigliani. Recruiting at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Fondazione Sandro Pitigliani · Observational
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.
Enrolled patients will receive first-line treatment with a CDK4/6 inhibitor + AI (anastrozole, letrozole or exemestane) in accordance with local practice. No drugs will be provided by the study Sponsor. Following disease progression on first-line therapy, subsequent, second-line therapy will be administered at physician discretion and as per physician choice.
For all participating patients, serum and plasma samples will be collected at the following time-points:
One sample of whole blood will be collected at baseline.
All blood samples will be taken concomitantly with blood draws for routine clinical practice.
To be eligible for the study, availability of material from one formalin fixed and paraffin embedded (FFPE) tumor block from a baseline biopsy of a metastatic site taken before starting treatment is mandatory. Although not mandatory for inclusion, material from an archival FFPE tumor block from the primary breast tumor must also be provided, whenever available. Additionally, material from one FFPE tumor block of a tissue biopsy from a metastatic site collected upon disease progression to first-line treatment with CDK4/6 in and AI will be collected whenever possible
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 150 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fondazione Sandro Pitigliani is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Pre- and post-menopausal patients with luminal (ER-positive and HER2-negative) MBC who have not received prior systemic therapy for MBC, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4/6i as per standard clinical practice.
Patients must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable). Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size.
The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable).
Note: Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size.
Exclusion Criteria:
Patients with ER+/HER2-negative metastatic breast cancer candidate to first-line treatment with a CDK4/6 inhibitor and an aromatase inhibitor as per standard clinical practice
Diagnostic Test: Thymidine kinase activity
DiviTum® assay determines the enzymatic activity of TK in serum samples
Also known as: Divitum
Progression free survival
time from inclusion date to date of first documentation of progression or death due to any cause, whichever occurs first
Time frame: 5 years
Clinical benefit rate
Complete Response, Partial Response, or Stable Disease ≥24 weeks
Time frame: 5 years
Plan to share: Undecided
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Fondazione Sandro Pitigliani