ClinicaliQ Trial Snapshot
- Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer — Recruiting • Phase III • Oncology • NCT07085767.
- What is being tested: Palazestrant (an oral selective oestrogen receptor degrader) combined with ribociclib (CDK4/6 inhibitor) versus the standard treatment of letrozole (aromatase inhibitor) with ribociclib as first-line therapy for ER+/HER2- advanced breast cancer.
- Patient eligibility overview: Women and men with ER+/HER2- advanced breast cancer who have not received any prior systemic anti-cancer treatment, representing a treatment-Phase IIIïve population requiring first-line intervention.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Eligibility Snapshot
- : * Adult female or male participants. * ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. * Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease). * De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic, and renal functions. * Female participants can be pre-, peri- or postmenopausal. * Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.