Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05501886 | Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) | PHASE3 | ACTIVE NOT_RECRUITING | 701 | — | — | Dec 8, 2022 | Dec 31, 2026 | Feb 10, 2026 | 235 | United States, Argentina +21 |
| NCT02684032 | A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer | PHASE1 | COMPLETED | 141 | — | — | Jun 14, 2016 | Jan 19, 2022 | Jul 27, 2022 | 41 | United States |
PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)
Number of patients for each response category, objective response rate (number of patients with a complete response (CR)) relative to the number of response evaluable patients
| Arm | Type | Description |
|---|---|---|
| Arm A - Patients Lacking PIK3CA Mutations (WT) | EXPERIMENTAL | Gedatolisib + Palbociclib + Fulvestrant |
| Arm B - Patients Lacking PIK3CA Mutations (WT) | EXPERIMENTAL | Gedatolisib + Fulvestrant |
| Arm C - Patients Lacking PIK3CA Mutations (WT) | ACTIVE_COMPARATOR | Fulvestrant |
| Arm D - Patients with PIK3CA Mutation (MT) | EXPERIMENTAL | Gedatolisib + Palbociclib + Fulvestrant |
| Arm E - Patients with PIK3CA Mutation (MT) | ACTIVE_COMPARATOR | Alpelisib + Fulvestrant |
| Arm F - Patients with PIK3CA Mutation (MT) | EXPERIMENTAL | Gedatolisib + Fulvestrant |
| Letrozole Cohort | EXPERIMENTAL | Letrozole combination cohort in dose escalation |
| Fulvestrant cohort | EXPERIMENTAL | Fulvestrant combination cohort in dose escalation |
| ARM A | EXPERIMENTAL | Gedatolisib + palbociclib + letrozole in dose expansion |
| ARM B | EXPERIMENTAL | Gedatolisib + palbociclib + fulvestrant in dose expansion |
| ARM C | EXPERIMENTAL | Gedatolisib + palbociclib + fulvestrant in dose expansion |
| Arm D | EXPERIMENTAL | Gedatolisib (3:1) + palbociclib + fulvestrant in dose expansion |
| Name | Type | Description |
|---|---|---|
| Gedatolisib | DRUG | Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off |
| Palbociclib | DRUG | Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off |
| Fulvestrant | DRUG | Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 |
| Alpelisib | DRUG | Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days) |
| Letrozole | DRUG | Letrozole at 2.5 mg daily |
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced 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 ...