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NCT03197935 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 333
- Enrollment target
NCT03197935 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 333 participants.
The verdict
NCT03197935, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 333 participants
- Enrollment target
Study Summary
This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).
Interventions
- DRUG Cyclophosphamide
- DRUG Placebo
- DRUG Doxorubicin
- DRUG Nab-paclitaxel
- DRUG Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2017-07-24 |
| Est. Completion | 2022-09-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03197935
The ClinicalTrials.gov registry entry for NCT03197935 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03197935 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03197935 about?
NCT03197935 is a clinical study titled "A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer". This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC)...
What is the current status of trial NCT03197935?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 333 participants. The study started on 2017-07-24. Estimated completion is 2022-09-28.
What interventions are being tested in trial NCT03197935?
The interventions under investigation include: Cyclophosphamide (DRUG), Placebo (DRUG), Doxorubicin (DRUG), Nab-paclitaxel (DRUG), Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody (DRUG).
Who is sponsoring clinical trial NCT03197935?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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