WO45654: INAVOLISIB, A CDK4/6 INHIBITOR, LETROZOLE AND PLACEBO IN ADVANCED BREAST CANCER

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER

• IRAS ID

  1010986

• Contact name

  Head of Regulatory Management

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• ISRCTN Number

  ISRCTN67316571

• Research summary

  The purpose of this study is to compare the effects, good or bad, of inavolisib plus palbociclib and letrozole versus placebo plus a palbociclib and letrozole on patients with HR  , HER2 advanced breast cancer. Participants in this study will get either inavolisib plus palbociclib and letrozole or placebo plus palbociclib and letrozole.
  Inavolisib is a drug that works by blocking a signaling pathway that is used by cancer cells to grow, known as the PI3K pathway. A gene in this pathway, called PIK3CA, is sometimes mutated in breast cancer. Other studies have shown that inavolisib treatment may be more effective for patients whose breast cancer has mutated PIK3CA. This study will only enroll patients who have breast cancer with mutated PIK3CA.
  Treatment will continue until disease progression per RECIST v1.1, unacceptable toxicity, withdrawal of consent, death, or if the study is terminated by the Sponsor. The total duration of study treatment for each individual is expected to range from 1 day to more than 30 months.Approximately 450 participants will be enrolled in this study. Participants will be randomized to one of the following treatment arms in a 1:1 ratio:
  Inavolisib plus palbociclib and letrozole
  • Inavolisib: 9-mg tablet starting dose taken by mouth (PO) once a day (QD) continuously, on Days 128 of each 28-day cycle, beginning on Day 1 of Cycle 1
  • Palbociclib: 125-mg capsule or tablet starting dose taken PO QD, ideally on Days 1 21 of each 28-day cycle, beginning on Day 1 of Cycle 1
  • Letrozole: 2.5-mg tablet taken PO QD continuously
  Placebo (for inavolisib) plus palbociclib and letrozole
  • Placebo (for inavolisib): 9-mg tablet starting dose taken PO QD continuously, on Days 128 of each 28-day cycle, beginning on Day 1 of Cycle 1
  • Palbociclib: 125-mg capsule or tablet starting dose taken PO QD, ideally on Days 1 21 of each 28-day cycle, beginning on Day 1 of Cycle 1
  • Letrozole: 2.5-mg tablet taken PO QD continuously

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  25/SW/0009

• Date of REC Opinion

  20 Mar 2025

• REC opinion

  Further Information Favourable Opinion