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Be Part of Research - Trial Details - A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Breast Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2023 Mar 2029

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Participants will be administered a 9 milligram (mg) inavolisib tablet orally once a day (PO QD) on Days 1-28 of each 28-day cycle.

Intervention Arm Group : Inavolisib + Fulvestrant;

Intervention Type : DRUG
Intervention Description : Participants will be administered 500 mg of fulvestrant on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle.

Intervention Arm Group : Alpelisib + Fulvestrant;Inavolisib + Fulvestrant;

Intervention Type : DRUG
Intervention Description : Alpelisib will be administered to participants at the approved dose in combination with fulvestrant: 300 mg taken PO QD and on days 1-28 of each 28-day cycle.

Intervention Arm Group : Alpelisib + Fulvestrant;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Princess Alexandra Hospital
    Harlow
    CM20 1QX
  • Blackpool Victoria Hospital
    Blackpool
    FY3 8NR
  • Western General Hospital
    Edinburgh
    EH4 2XU
  • Royal Hampshire County Hospital
    Winchester
    SO22 5DG
  • St John's Hospital
    Livingston
    EH54 6PP
  • St Bartholomew's Hospital
    London
    EC1M 6BQ
  • Royal Preston Hosptial
    Preston
    PR2 9HT
  • Dumfries and Galloway Royal Infirmary
    Dumfries
    DG1 4AP
  • Maidstone & Tonbridge Wells Hospital
    Maidstone
    ME16 9QQ
  • Mount Vernon & Watford Trust Hospital
    Northwood
    HA6 2RN
  • Basingstoke and North Hampshire Hospital
    Basingstoke
    RG24 9NA
  • Churchill Hospital
    Oxford
    OX3 7LE


The study is sponsored by Hoffmann-La Roche





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Read full details for Trial ID: NCT05646862
Last updated 28 April 2025

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