Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

FINER : A Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase III trial is trying to find out if a new targeted therapy (Ipatasertib) can slow the growth of advanced breast cancer when added to standard hormone therapy (Fulvestrant).
 

This trial is treating patients with advanced HER2-2 negative and ER positive breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

Cooperative Group

Canadian Cancer Trials Group

Commercial Sponsor

Hoffmann-La Roche

Summary

This is a randomised, triple-blind study with experimental and placebo comparator arms. Participants in the Experimental Arm will receive Ipatasertib (400mg administered orally daily days 1-21 every 28 days) in combination with Fulvestrant (500mg administered via intramuscular injection on days 1 and 15 in cycle one, and only on day 1 in subsequent cycles). Participants in the Placebo Comparator Arm will receive Fulvestrant (500mg administered via intramuscular injection on days 1 and 15 in cycle one, and only on day 1 in subsequent cycles) in combination with a placebo (administered orally daily days 1-21 every 28 days).

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Eleanor Edwards
El.Edwards@alfred.org.au
03 9076 2297

Not Recruiting Hospitals Read MoreRead more

Not yet recruiting

Victorian Breast and Oncology Care
East Melbourne
Ms Kayte Robinson
kayte@vboc.com.au
03 9417 4666

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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