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NCT03765983 · ClinicalTrials.gov registry record · Phase 2
GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT03765983: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT03765983 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03765983, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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®)
Primary Outcome
Defined as the proportion of patients with partial or complete response in the CNS, per RANO-BM criteria (Complete response \[CR\]: disappearance of all CNS target lesions sustained for at least 4 weeks, no new lesions, no corticosteroids, stable or improved clinically; Partial response \[PR\]: At least 30% decrease in the sum of longest diameter of CNS target lesions, taking as reference the baseline sum, sustained for at least 4 weeks, no new lesions, stable to decreased corticosteroid dose, s
Interventions
- DRUG Trastuzumab
- DRUG GDC-0084
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-02-25 |
| Est. Completion | 2024-05-14 |
| Phase | Phase 2 |
Why NCT03765983 stopped before completion
NCT03765983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT03765983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03765983 about?
NCT03765983 is a clinical study titled "GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases". 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®)
What is the current status of trial NCT03765983?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2019-02-25. Estimated completion is 2024-05-14.
What interventions are being tested in trial NCT03765983?
The interventions under investigation include: Trastuzumab (DRUG), GDC-0084 (DRUG).
Who is sponsoring clinical trial NCT03765983?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03765983's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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