Study on Afuresertib and Fulvestrant for Advanced HR+/HER2- Breast Cancer

Sponsor: Laekna Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04851613

Provider View

This clinical trial is testing a combination of two drugs, afuresertib and fulvestrant, to see if they are safe and effective for patients with advanced HR+/HER2- breast cancer who have not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if the combination of afuresertib and fulvestrant can help control breast cancer that is hormone receptor-positive (HR+) and does not have the HER2 protein (HER2-). It is for patients whose cancer has either progressed despite previous hormone therapy or has returned after treatment. Participants can have had up to two previous treatments for advanced cancer, including hormone therapy and possibly chemotherapy.

Description

This study is for patients with advanced HR+/HER2- breast cancer that has either worsened during hormone therapy or returned after treatment. Participants can have had up to two previous treatments for advanced cancer, including hormone therapy and possibly chemotherapy. The study will test the safety and effectiveness of combining afuresertib with fulvestrant.

Eligible patients must be 18 years or older and have confirmed HR+/HER2- breast cancer. They should have had 1 to 2 previous treatments for advanced cancer, with at least one being hormone therapy. Patients must have measurable cancer that can be tracked using scans.

In the first part of the study, patients will need to provide a tumor sample for genetic testing. In the second part, a blood sample is required for specific genetic tests. Patients must be in good health, able to take oral medication, and not have any conditions that would interfere with the study drugs. Women of childbearing age must use effective birth control during and after the study.

Patients cannot participate if they have had recent major surgery, other active cancers, a history of seizures, or active brain metastases. They also cannot have previously used certain cancer drugs or have uncontrolled high blood pressure, active hepatitis, or HIV. Certain medications that interact with the study drugs are also not allowed.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have confirmed HR+/HER2- breast cancer.
  • Cancer must have progressed during hormone therapy or returned after treatment.
  • Have had 1 to 2 previous treatments for advanced cancer, including hormone therapy.
  • Have measurable cancer that can be tracked using scans.
  • Provide a tumor or blood sample for genetic testing.
  • Be in good health with a performance status of 0 or 1.
  • Have adequate organ function.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception.
  • Must be able to take oral medication and not have gastrointestinal issues affecting drug absorption.
  • No contraindications to fulvestrant.

Exclusion Criteria

  • Recent major surgery or systemic infection requiring hospitalization or IV antibiotics.
  • Other active cancers requiring treatment within the last 3 years.
  • History of seizures or conditions that may cause seizures.
  • Active brain metastases or carcinomatous meningitis.
  • Previous treatment with fulvestrant, SERDs, PI3K/AKT/mTOR inhibitors, or CDK4/6 inhibitors.
  • Heart rhythm issues with QTcF > 470 msec.
  • Uncontrolled high blood pressure.
  • Active hepatitis B or C infection.
  • Known HIV infection.
  • Taking medications that interact with the study drugs.
  • Ineligible for hormone therapy due to specific cancer conditions.

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