Palbociclib

SEP 11, 2026 · PHASE 2 TRIAL

Palbociclib After CDK and Endocrine Therapy (PACE)

ClinicalTrials.gov

This is a Phase 2 interventional trial with planned enrollment of 220 participants studying drug combinations for metastatic breast cancer; results are not reported in this registry record.

SEP 8, 2026 · PHASE 1 TRIAL

To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

ClinicalTrials.gov

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.

SEP 8, 2026 · PHASE 3 TRIAL

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

ClinicalTrials.gov

This is a Phase 3 RCT registration with no results posted; the study is actively recruiting and designed to test a novel PIK3CA inhibitor in advanced breast cancer, but outcome data are not yet available.

AUG 19, 2026 · PHASE 3 TRIAL

BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease

ClinicalTrials.gov

This is an active Phase 3 trial registration with no results posted; the study is still recruiting and outcomes are not yet reported.

AUG 17, 2026 · PHASE 3 TRIAL

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

ClinicalTrials.gov

This is a registry record for an actively recruiting Phase 1b/3 trial with no results posted; it describes study design and planned enrollment only.

AUG 11, 2026 · OBSERVATIONAL STUDY

A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

ClinicalTrials.gov

This is an active observational registry study with no reported results; it describes a planned real-world effectiveness evaluation in a specific population but carries no outcome data.

JUN 24, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Ibrance (Efficacy)

U.S. Food and Drug Administration

FDA supplemental approval for palbociclib (Ibrance) indicates a regulatory action granting efficacy-based authorization, but the record does not contain clinical trial data, endpoints, or comparative outcomes.