ClinicaliQ Trial Snapshot
- Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) — Recruiting • Phase III • Oncology • NCT06757634.
- Treatment being tested: Gedatolisib (a PI3K/mTOR inhibitor) combined with palbociclib (CDK4/6 inhibitor) and endocrine therapy, compared to standard palbociclib plus endocrine therapy in first-line advanced breast cancer.
- Patient eligibility overview: Women with locally advanced or metastatic HR-positive, HER2-negative breast cancer suitable for first-line systemic treatment; this represents the most common hormone receptor-positive breast cancer subtype.
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 is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Eligibility Snapshot
- : 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer
- Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study. 3. Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment. 4. Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET. 5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status. 6. Permitted prior therapies: 1. (neo)adjuvant fulvestrant only if the treatment duration < 6 months 2. (neo)adjuvant chemotherapy 3. (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i i. Study 1: if disease progression was on or within event occurred >6 months of discontinuation after completion of…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.