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OncoMatch/Clinical Trials/NCT06757634

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

Is NCT06757634 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Arm B: Palbociclib or Ribociclib + Fulvestrant and Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant for breast cancer.

Phase 3RecruitingCelcuity IncNCT06757634Data as of May 2026

Treatment: Arm B: Palbociclib or Ribociclib + Fulvestrant · Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant — This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: PIK3CA mutational status testing required

Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Must have received: endocrine therapy — (neo)adjuvant

Progression of disease during or within 12 months of completing (neo)adjuvant ET

Cannot have received: PI3K inhibitor

Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor

Cannot have received: Akt inhibitor

Prior treatment with a protein kinase B (Akt) inhibitor

Cannot have received: mTOR inhibitor

Prior treatment with a mechanistic target of rapamycin (mTOR) inhibitor

Cannot have received: systemic anticancer therapy

Exception: for ABC

Prior treatment with systemic anticancer therapy for ABC

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California
  • Providence Medical Foundation · Fullerton, California
  • UCLA Hematology Oncology Santa Monica · Los Angeles, California
  • BRCR Medical Center, Inc- Internal Medicine · Plantation, Florida
  • BRCR Medical Center, INC · Tamarac, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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