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Phosphoinositide 3-Kinase (PI3K) Inhibitor

GDC-0084 + Trastuzumab for HER2-Positive Breast Cancer

Phase 2

Waitlist Available

Led By Jose P Leone, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All Cohorts: Participant must be able to swallow and retain oral medication

All Cohorts: The participant is ≥18 years old

Must not have

Active infection requiring IV antibiotics at the time of protocol therapy initiation

CNS complications for whom urgent neurosurgical intervention is indicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of GDC-0084 in combination with trastuzumab as a possible treatment for HER2-Positive Breast Cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions related to drug composition, issues from oral medication intake, heart complications due to Trastuzumab's effect on cardiac function, and general side effects like fatigue or digestive problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow and keep down pills.

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I am 18 years old or older.

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My disease is either not changing, absent, or getting worse.

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I have brain metastases, haven't had brain radiation, and don't need steroids for symptoms.

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My breast cancer is confirmed to be HER2-positive.

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My corticosteroid dose has been stable or decreasing for the last week.

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I can take care of myself but might not be able to do heavy physical work.

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I have new or worsening brain tumors that need surgery.

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I have a brain tumor that is growing and measures at least 10 mm.

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My organ and bone marrow functions are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on IV antibiotics for an infection when starting the treatment.

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I need urgent brain surgery due to complications.

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I do not have another life-threatening cancer.

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I have a serious illness that is not under control.

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I am not taking any strong medication that affects liver enzymes.

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I haven't had chemotherapy or targeted therapy in the last 14 days.

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I am not in a severe health crisis due to my cancer spreading.

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My cancer has spread to the lining of my brain and spinal cord.

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I have lung problems due to a disease or extensive cancer spread.

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I have previously been treated with a PI3K or mTOR inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate in the CNS

To evaluate the correlation between inhibition of p-4EBP1 in resected brain tumor tissue and intracranial response in the corresponding patient-derived xenograft (PDX) models of BCBM

Secondary study objectives

CBR

DOR

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

+3 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GDC-0084

2018

Completed Phase 1

~60

Trastuzumab

2014

Completed Phase 4

~5190