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 (Sep 2026). This Phase 3 trial studies multiple treatments including Arm A: Gedatolisib + Palbociclib + Fulvestrant and Arm B: Ribociclib + Fulvestrant for breast cancer.
Treatment: Arm A: Gedatolisib + Palbociclib + Fulvestrant · Arm B: Ribociclib + Fulvestrant · Arm C: Gedatolisib + Palbociclib + Letrozole · Arm D: Ribociclib + Letrozole — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA any tested (testing required; no eligibility threshold specified)
Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status
Required: ESR1 expression (positive)
HR+/HER2- breast cancer
Required: HER2 (ERBB2) wild-type (absence)
HR+/HER2- breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy — (neo)adjuvant
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
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: selective estrogen receptor degrader
Exception: except fulvestrant, used in (neo)adjuvant setting
Prior treatment with ... any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting
Cannot have received: systemic anticancer therapy for advanced breast cancer
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 →Frequently asked questions
Is NCT06757634 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PI3K inhibitor, Akt inhibitor, mTOR inhibitor disqualifies patients from enrollment.
Does this trial require PIK3CA?
Yes, PIK3CA any tested is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages