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RecruitingLast updated: 26 April 2024

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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Trial 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

  • Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
  • Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
  • Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
  • Evidence of clinically and/or radiologically documented disease
  • ≥ 18 years of age
  • ECOG performance status of 0 or 1
  • No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy

    • Must not have received more than one prior line of treatment with a CDK 4/6 inhibitor and an AI in the advanced disease setting.
    • Treatment with CDK 4/6 inhibitor and AI must have been the most recent treatment prior to registration for this study
  • Adequate hematology and organ function, in the absence of growth factors

    • Absolute neutrophils > 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Hemoglobin > 90 g/L
    • Total Bilirubin ≤ 1.5 x ULN (upper limit of normal) or ≤ 3 x ULN if confirmed Gilbert's Syndrome
    • ALT and AST ≤ 2.5 x ULN (or ≤ 5.0 x ULN if liver or bone metastasis)
    • Alkaline phosphatase ≤ 2.0 x ULN (or ≤ 5.0 x ULN if liver metastases, ≤ 7.0 x ULN if bone metastasis)
    • Fasting glucose ≤ 8.3 mmol/L
    • HbA1c ≤ 7.5%
    • Serum albumin ≥ 30 g/L
    • INR ≤ 1.2
    • Serum Creatinine or Creatinine clearance ≤ 1.5 x ULN or ≥ 50 mL/min; measured directly by 24-hour urine sampling or as calculated by Crockcroft and Gault equation

Exclusion

  • Untreated or symptomatic CNS metastases, radiation treatment for CNS metastases within 28 days
  • Active inflammatory bowel disease, bowel inflammation, inability to swallow oral medication or GI condition that alters oral absorption
  • Prior treatment with fulvestrant, selective estrogen receptor degraders (SERDs) or known inhibitors of the PI3K pathway including PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
  • Mean QT interval corrected for heart rate (QTc) ≥ 480 msec by ECG or history of familial long QT syndrome
  • Active or uncontrolled infections or serious illnesses or medical conditions
  • Clinically significant liver diseases
  • History of lung disease or history of opportunistic infections
  • Type 1 or Type 2 diabetes mellitus requiring insulin
  • Grade ≥ 2 uncontrolled hypercholesterolemia or hypertriglyceridemia
  • Known abnormalities in coagulation
  • History of hypersensitivity to the study drugs or components
  • Pregnant or lactating women

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.

Ask your doctor if this trial could be right for you.

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