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NCT03199885 · ClinicalTrials.gov registry record · Phase 3
Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
NCT03199885: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT03199885 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 190 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03199885, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
Study Summary
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells. \*NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.
Interventions
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- DRUG Atezolizumab
- PROCEDURE Biopsy
- PROCEDURE Bone Scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2025-04-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03199885
The ClinicalTrials.gov registry entry for NCT03199885 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03199885 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03199885 about?
NCT03199885 is a clinical study titled "Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer". This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the grow...
What is the current status of trial NCT03199885?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2019-04-05. Estimated completion is 2025-04-04.
What interventions are being tested in trial NCT03199885?
The interventions under investigation include: Computed Tomography (PROCEDURE), Docetaxel (DRUG), Atezolizumab (DRUG), Biopsy (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT03199885?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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