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NCT04740918 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 96
- Enrollment target
NCT04740918: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04740918 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 96 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04740918, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 96 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
Primary Outcome
PFS was defined as the time from randomization to the first occurrence of documented disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm).
Interventions
- DRUG Atezolizumab
- OTHER Placebo
- DRUG Trastuzumab Emtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2024-06-19 |
| Phase | Phase 3 |
Why NCT04740918 stopped before completion
NCT04740918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Atezolizumab is the first listed.
NCT04740918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04740918 about?
NCT04740918 is a clinical study titled "A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)". This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior tra...
What is the current status of trial NCT04740918?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2021-06-07. Estimated completion is 2024-06-19.
What interventions are being tested in trial NCT04740918?
The interventions under investigation include: Atezolizumab (DRUG), Placebo (OTHER), Trastuzumab Emtansine (DRUG).
Who is sponsoring clinical trial NCT04740918?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04740918's enrollment target sits among peer trials
96 1718th of 2000 higher than 282 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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