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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Arm A: Gedatolisib + Palbociclib + Fulvestrant — DRUG
  Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex
• Arm B: Ribociclib + Fulvestrant — DRUG
  Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 weeks Other Names: • Faslodex
• Arm C: Gedatolisib + Palbociclib + Letrozole — DRUG
  Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Drug: Letrozole Participants will receive oral letrozole daily.
• Arm D: Ribociclib + Letrozole — DRUG
  Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Drug: Letrozole Participants will receive oral letrozole daily.

Study Details

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.

Key Dates

Start date

Jul 24, 2025

Status verified

May 2026

Primary completion

Mar 31, 2029

Completion

Jul 30, 2033

Study Design

Enrollment

1,180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Gedatolisib + Palbociclib + Fulvestrant
  Subjects with treatment-naïve endocrine-resistant ABC.
• Active Comparator: Arm B: Ribociclib + Fulvestrant
  Subjects with treatment-naïve endocrine-resistant ABC.
• Experimental: Arm C: Gedatolisib + Palbociclib + Letrozole
  Subjects with treatment-naïve endocrine-sensitive ABC.
• Active Comparator: Arm D: Ribociclib + Letrozole
  Subjects with treatment-naïve endocrine-sensitive ABC.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From date of randomization to the date of death due to any cause, up to approximately 48 months ]

Central Contacts

• Nadene Zack, MS
  844-310-3900
  [email protected]

Locations (22)

Find similar trials in Duarte, CA

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