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
Public ClinicalTrials.gov record NCT03197935. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03197935
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 333 participants
Conditions and interventions
Conditions
Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Drug
- Placebo Drug
- Nab-paclitaxel Drug
- Doxorubicin Drug
- Cyclophosphamide Drug
- Filgrastim Drug
- Pegfilgrastim Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 24, 2017 (Actual)
- Primary completion
- Apr 3, 2020 (Actual)
- Completion
- Sep 28, 2022 (Actual)
- Last update posted
- Oct 26, 2023
2017 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Carrollton | Georgia | 30117 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| HCA Midwest Division | Kansas City | Missouri | 64132 | — |
| The Valley Hospital; Valley Medical Group | Paramus | New Jersey | 07652 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | 37204 | — |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | — |
| Cancer Care Northwest | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03197935, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2023 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03197935 live on ClinicalTrials.gov.