Trial Summary
What is the purpose of this trial?This research study is studying a drug called GDC-0084 as a possible treatment for HER2-Positive Breast Cancer.
The drugs involved in this study are:
* GDC-0084
* Trastuzumab (Herceptin®)
Eligibility Criteria
This trial is for adults with HER2-positive breast cancer that has spread to the brain. They must have measurable brain metastasis, normal organ and marrow function, no prior treatments with certain inhibitors, and not be on strong CYP3A4 inducers or inhibitors. Pregnant women or those unable to swallow oral medication are excluded.Inclusion Criteria
I can swallow and keep down pills.
I am 18 years old or older.
My disease is either not changing, absent, or getting worse.
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Exclusion Criteria
You have had a bad reaction to trastuzumab in the past.
Current use or history of receiving a non-approved, investigational treatment within 14 days prior to initiation of protocol therapy
You cannot have an MRI due to a known medical reason.
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Participant Groups
The study tests GDC-0084 in combination with Trastuzumab (Herceptin®) as a treatment for patients with HER2-positive breast cancer that has metastasized to the brain. It aims to see how well these drugs work together in this specific patient group.
2Treatment groups
Experimental Treatment
Group I: Cohort B: a pre-surgical window cohortExperimental Treatment2 Interventions
GDC-0084 45 mg administered orally once daily Trastuzumab administered at a dose of 8 mg/kg intravenously (IV) loading dose; followed by 6 mg/kg IV every 3 weeks thereafter Surgical brain metastasis resection
Group II: Cohort A: single-arm, two stage, phase II cohortExperimental Treatment2 Interventions
GDC-0084 45 mg administered orally once daily Trastuzumab administered at a dose of 8 mg/kg intravenously (IV) loading dose; followed by 6 mg/kg IV every 3 weeks thereafter
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana-Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
Kazia Therapeutics LimitedIndustry Sponsor