NCT04660435Recruiting
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
Identification and Monitoring of Resistance to First-line Treatment With CDK 4/6 Inhibitors in Combination With Aromatase Inhibitors in Patients With Metastatic Luminal Breast Cancer Through Non-invasive Biomarkers
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 3 Dec 2020
- Start date
- 1 Dec 2020
- Primary completion date
- 1 Dec 2029
- Lead sponsor
- Fondazione Sandro Pitigliani
- NCT number
- NCT04660435
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Dec 2020 to the primary completion date, 1 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Who the study is looking for
- 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
- 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.
- Hystologic material from one formalin-fixed, paraffin-embedded (FFPE) tumor block from a diagnostic core or excisional biopsy of a metastatic lesion, taken before study entry must be provided (patients with bone-only disease will be accepted into the trial without a biopsy of the metastatic site). Hystologic material from an additional biopsy (core or excisional) taken at time of disease progression on the study treatment must also be provided, if clinically feasible. When available, hystologic material from an FFPE tumor block from the primary breast cancer must also be submitted.
- The patient agrees to provide blood samples. at the trial specified time points
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Santo Stefano Coordinator of this site? Confirm its status | Prato | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.