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Phosphoinositide 3-Kinase (PI3K) Inhibitor
GDC-0084 + Trastuzumab for HER2-Positive Breast Cancer
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
CBR
DOR
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
+3 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
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
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,901 Total Patients Enrolled
141 Trials studying Breast Cancer
22,570 Patients Enrolled for Breast Cancer
Kazia Therapeutics LimitedIndustry Sponsor
11 Previous Clinical Trials
1,543 Total Patients Enrolled
Jose P Leone, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to trastuzumab in the past.I can swallow and keep down pills.I am 18 years old or older.You cannot have an MRI due to a known medical reason.I have not had major surgery in the last 3 weeks.I am not on IV antibiotics for an infection when starting the treatment.My disease is either not changing, absent, or getting worse.I have brain metastases, haven't had brain radiation, and don't need steroids for symptoms.I need urgent brain surgery due to complications.I do not have another life-threatening cancer.I have a serious illness that is not under control.Your heart's QT interval is longer than 470 milliseconds.I am not taking any strong medication that affects liver enzymes.I haven't had chemotherapy or targeted therapy in the last 14 days.I had surgery or radiation for my cancer, but still have untreated or new lesions.My breast cancer is confirmed to be HER2-positive.I am not in a severe health crisis due to my cancer spreading.Your heart's pumping function is strong, as shown in an echocardiogram or MUGA scan.My cancer has spread to the lining of my brain and spinal cord.I am not pregnant and agree to use birth control.I understand the study's requirements and have signed the consent form.My corticosteroid dose has been stable or decreasing for the last week.I have lung problems due to a disease or extensive cancer spread.I can take care of myself but might not be able to do heavy physical work.I have new or worsening brain tumors that need surgery.I have a brain tumor that is growing and measures at least 10 mm.You have had a bad reaction to drugs similar to GDC-0084.I have previously been treated with a PI3K or mTOR inhibitor.My organ and bone marrow functions are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B: a pre-surgical window cohort
- Group 2: Cohort A: single-arm, two stage, phase II cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the Trastuzumab side effects that have been observed?
"While there is some data suggesting that Trastuzumab is safe, as this is only a phase 2 trial, it cannot yet be confirmed to be effective. Consequently, it received a score of 2."
Answered by AI
Are new participants currently being sought for this trial?
"From what is detailed on clinicaltrials.gov, this experiment is still looking for participants. The trial was originally announced on February 11th, 2019 and the most recent update occurred on March 2nd, 2022."
Answered by AI
What cancers respond best to Trastuzumab?
"Trastuzumab is an appropriate treatment option for breast cancer patients that have a high risk of disease recurrence and have not yet received any prior lines of treatment."
Answered by AI
What is the total number of participants who have signed up for this clinical trial?
"That is correct, the online information regarding this clinical trial indicates that it is currently seeking participants. The listing was first published on February 11th, 2019 and has been edited most recently on March 2nd, 2022. This particular research project requires 47 patients from a single location."
Answered by AI
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