To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer

ConditionsMetastatic Breast Cancer ER Positive Breast Cancer HER2-negative 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

This trial does not accept healthy volunteers

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 population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Thymidine kinase activity
Diagnostic test
DiviTum® assay determines the enzymatic activity of TK in serum samples

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Women with ER+/Her2 negative metastatic breast cancer1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

Clinical benefit rate

Complete Response, Partial Response, or Stable Disease ≥24 weeks

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Sandro Pitigliani

Lead sponsor

Clinical Research Technology S.r.l.

Collaborator

Source ClinicalTrials.gov

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