Study on GDC-0084 and Trastuzumab for Patients with HER2-Positive Breast Cancer that has Spread to the Brain

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03765983

Provider View

This clinical trial is exploring a new treatment using the drug GDC-0084 in combination with Trastuzumab (Herceptin®) for patients with HER2-Positive Breast Cancer that has spread to the brain.

Patient Parameters

Program Overview

This study is testing a new drug called GDC-0084 to see if it can help treat HER2-Positive Breast Cancer that has spread to the brain. The study involves two drugs: GDC-0084 and Trastuzumab (Herceptin®).

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment to see if it works for a specific disease. The new treatment being studied is GDC-0084, which is not yet approved by the FDA for any disease. Trastuzumab is already approved by the FDA and is used to treat HER2-positive breast cancer.

GDC-0084 works by blocking a protein called PI3-kinase, which cancer cells use to grow. Trastuzumab is a targeted therapy that attaches to HER2 receptors on breast cancer cells, blocking signals that tell the cells to grow and marking them for destruction by the immune system. This study aims to see how well the combination of GDC-0084 and Trastuzumab works in treating your cancer.

Eligibility Criteria

Inclusion Criteria

  • Have at least one brain tumor that is 10 mm or larger.
  • Have new or growing brain tumors, and meet one of the following:
    • Treated with surgery or radiation but still have untreated tumors.
    • Had previous brain radiation and now have new or growing tumors.
    • Have not had brain radiation but have no symptoms and do not need steroids.
  • Have HER2-positive breast cancer confirmed by lab tests.
  • Be in good overall health with a performance status of 0 to 2.
  • Have a heart function of 50% or higher.
  • Be on a stable or decreasing dose of steroids for at least 7 days before starting treatment.
  • Be 18 years or older.
  • Have normal organ and bone marrow function, including:
    • Neutrophil count of at least 1,000/μl
    • Platelet count of at least 75,000/μl
    • Hemoglobin of at least 9 g/dL
    • Total bilirubin within normal limits, except for certain conditions
    • Liver enzymes within specified limits
    • Kidney function within specified limits
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
  • Be able to understand and agree to the study requirements.
  • Be able to swallow pills.

Exclusion Criteria

  • Have a severe or urgent medical condition requiring immediate treatment.
  • Have cancer spread to the brain lining (leptomeningeal metastases).
  • Cannot have an MRI due to medical reasons.
  • Have had chemotherapy or targeted therapy within 14 days before starting the study.
  • Have used a PI3K or mTOR inhibitor before.
  • Have used an investigational treatment within 14 days before starting the study.
  • Have allergies to similar drugs as GDC-0084.
  • Have uncontrolled health issues, such as infections, heart problems, or diabetes.
  • Are pregnant or breastfeeding.
  • Have another active, serious cancer.
  • Have had major surgery within 21 days before starting the study.
  • Have an active infection needing IV antibiotics.
  • Have severe lung disease causing breathing problems.
  • Have a known intolerance to Trastuzumab.
  • Have a prolonged QT interval on an ECG.
  • Are taking medications that strongly affect the liver enzyme CYP3A4, unless they can be stopped or changed.

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