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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). 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.
Primary Outcome
Will be determined using the current Response Evaluation Criteria in Solid Tumors 1.1 criteria. Analysis will be based on the intent to treat population. The stratified log-rank test will be used to compare the progression free survival between the two treatment arms with the following stratification factors: prior neoadjuvant or adjuvant therapy with trastuzumab (no; yes), estrogen receptor status (positive; negative), disease sites (any visceral without brain metastasis; non-visceral only with
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 |
Why NCT03199885 stopped before completion
NCT03199885 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03199885 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03199885's enrollment target sits among peer trials
190 1402nd of 2000 higher than 593 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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