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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03197935 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 333 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
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 |
What the finished NCT03197935 record still lists
NCT03197935 is an interventional study that assigns participants to a tested intervention. The registered 333 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 (57% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03197935 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03197935's enrollment target sits among peer trials
333 1061st of 2000 higher than 940 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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