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Palbociclib / Letrozole / Solid Tumor · Phase 1 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration for inavolisib, a PIK3CA inhibitor, designed to establish safety, tolerability, and pharmacokinetics as a single agent and in combination with endocrine and targeted therapies in solid tumors and breast cancer. No outcome data are posted in this registry record; the study is active but not recruiting.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Breast Cancer, Solid Tumor; age from 18 Years. Intervention: Stage I Arm A: Inavolisib Single Agent; Stage I Arm B: Inavolisib + Palbociclib + Letrozole; Stage I Arm C: Inavolisib + Letrozole; Stage II Arm B: Inavolisib + Palbociclib + Letrozole; Stage II Arm C: Inavolisib + Letrozole; Stage II Arm…. n = 200. 12 sites across 5 countries.
This is a Phase 1 trial registration for inavolisib, a PIK3CA inhibitor, designed to establish safety, tolerability, and pharmacokinetics as a single agent and in combination with endocrine and targeted therapies in solid tumors and breast cancer. No outcome data are posted in this registry record; the study is active but not recruiting.
Open-label design without control arm limits inference about tolerability differences between arms. No efficacy endpoints are planned; this is a Phase 1 dose-finding and safety study.
This trial will establish the safety profile and recommended Phase 2 dose of inavolisib in combination with standard therapies, informing subsequent efficacy studies. Clinicians should await Phase 2 and later results before considering therapeutic use.
This is a Phase 1 safety and pharmacokinetics study registration with no results posted; it describes planned enrollment and design only, typical of early-stage clinical development.
As stated by the source record.
Quoted from the source exactly as published.
This trial will establish the safety profile and recommended Phase 2 dose of inavolisib in combination with standard therapies, informing subsequent efficacy studies. Clinicians should await Phase 2 and later results before considering therapeutic use.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03006172). This is a study registration, not published results. Lead sponsor: Genentech, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 200 participants (ACTUAL). Conditions: Breast Cancer, Solid Tumor. Interventions: DRUG: Inavolisib; DRUG: Fulvestrant; DRUG: Letrozole; DRUG: Palbociclib; DRUG: Metformin; DRUG: Trastuzumab; DRUG: Pertuzumab. Primary outcome measures: Stage 1: Percentage of Participants With Dose Limiting Toxicities , Day 1 up to Day 28 (for Stage 1 Arm A: Day 1 up to Day 35); Recommended Phase II Dose of Inavolisib , Day 1 up to Day 28 (for Stage 1 Arm A: Day 1 up to Day 35); Percentage of Participants With Adverse Events and Serious Adverse Events , Day 1 up to 6 years. Brief summary: This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and/or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of seven regimens: inavolisib as a single agent (Arm A), inavolisib in combination with palbociclib and letrozole (Arm B), inavolisib in combination with letrozole (Arm C), inavolisib in combination with fulvestrant (Arm D), inavolisib in combination with palbociclib and fulvestrant (Arm E), inavolisib in combination with palbociclib, fulvestrant, and metformin (Arm F), and inavolisib in combination with trastuzumab and pertuzumab (and letrozole or fulvestrant, if applicable (Arm G)).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.