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NCT06129786: OVERTuRE

Overcoming Therapy Resistance in ER+ Breast Cancer Patients: a Translational Project (OVERTuRE)

Recruiting now Last updated 13 November 2023
What this trial tests

trial in Breast Cancer in 74 participants. Currently enrolling.

Timeline
18 May 2023
Primary endpoint
18 May 2026
18 May 2026

Quick facts

Lead sponsorCentro di Riferimento Oncologico - Aviano
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment74
Start date18 May 2023
Primary completion18 May 2026
Estimated completion18 May 2026
Sites2 locations across Italy

Conditions studied

Sponsor

Centro di Riferimento Oncologico - Aviano

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients presenting with a de novo diagnosis of luminal-like advanced breast cancer (ABC) or with disease recurrence after \>12 months from the end of adjuvant ET, are generally candidate to a first line therapy with an aromatase inhibitor in association with a CDK4/6i. Disease recurrence in \<12 months from the end of adjuvant ET defines the disease as "endocrine resistant" and identifies patients that should receive a first line therapy with the selective estrogen receptor degrader (SERD) Fulvestrant in association with the CDK4/6i Ribociclib, according to the results of the MONALEESA-3 trial. A significant percentage of ABC patients develops a primary resistance with disease progression within the first 6 months from the beginning of the treatment. Furthermore, another relevant percentage of patients initially responding to the therapy, will later develop a secondary resistance, thus progressing after a median of 2 years from the beginning of the treatment. Thereby, it is crucial to identify biomarkers that could be predictive of a response or a resistance to ET and/or CDK4/6i, to provide the best therapeutic strategy, tailored upon both clinico-pathological and molecular characteristics. Numerous pathways associated with resistance to CDK4/6i have been investigated by means of liquid biopsy analysis. The aim of this study is to identify potential biomarkers predictive of a clinical benefit in patients receiving a first line therapy with AI/fulvestrant (+/- LH-RH analogue) in association with a CDK4/6i for luminal-like advanced breast cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Centro di Riferimento Oncologico - Aviano trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06129786.

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