GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Meta… (NCT03765983) | Clinical Trial Compass
TerminatedPhase 2
GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases
Stopped: participants are no longer being examined or receiving intervention
United States17 participantsStarted 2019-02-25
Plain-language summary
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®)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Cohort A:
* At least one measurable CNS metastasis, defined as ≥ 10 mm in at least one dimension.
* Unequivocal evidence of new and/or progressive brain metastases, and at least one of the following scenarios:
* Treated with SRS or surgery with residual un-treated lesions remaining. Such participants are eligible for immediate enrollment on this study providing that at least one untreated lesion is measurable
* Participants who have had prior WBRT and/or SRS and then whose lesions have subsequently progressed or who have new lesions are also eligible. In this case, lesions which have been treated with SRS may be considered as target lesions if there is unequivocal evidence, in the opinion of the treating physician, of progression following SRS.
* Participants who have not previously been treated with cranial radiation (e.g., WBRT or SRS) are eligible to enter the study, but such participants must be asymptomatic from their CNS metastases and not requiring corticosteroids for symptom control.
* Participants who present with systemic stable/absent or progressive disease are eligible to this trial, as long as they fulfill one of the above criteria.
Cohort B:
* New and/or progressive brain metastasis(es) with clinical indication for resection.
* All Cohorts:
* Pathologically confirmed HER2-positive MBC by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate in the CNS
Timeframe: Assessed every 2 cycles for the first 4 cycles, and then every 3 cycles thereafter, until CNS progression or initiation of new anticancer therapy, up to ~34 weeks.
2
Correlation Between Inhibition of p-4EBP1 in Resected Brain Tumor Tissue and Intracranial Response in the Corresponding Patient-derived Xenograft (PDX) Models of BCBM