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RecruitingLast updated: 15 August 2023

FINER: 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)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

Clinical summary

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).

Conditions

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

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

FINER

More information

Trial Identifiers

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Commercial Sponsor

Hoffmann-La Roche, Canadian Cancer Trials Group

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

Eligibility

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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