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Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
NCT03281954 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery. Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Atezolizumab
Study Locations (20)
California
- Kaiser Permanente-Anaheim — Anaheim
- Kaiser Permanente-Baldwin Park — Baldwin Park
- Kaiser Permanente-Bellflower — Bellflower
- Arrowhead Regional Medical Center — Colton
- City of Hope — Duarte
- Kaiser Permanente-Fontana — Fontana
- Kaiser Permanente-Harbor City — Harbor City
- Kaiser Permanente-Irvine — Irvine
- Cancer and Blood Specialty Clinic — Los Alamitos
- Kaiser Permanente-Sunset — Los Angeles
- Kaiser Permanente-West Los Angeles — Los Angeles
- Kaiser Permanente-Panorama City — Panorama City
- Kaiser Permanente-Riverside — Riverside
- Kaiser Permanente Medical Group — San Diego
- Kaiser Permanente-Zion — San Diego
- Kaiser Permanente - Otay — San Diego
Arkansas
- St. Bernard's Medical Center — Jonesboro
- St. Bernard's Medical Center — Paragould
Alabama
- University of South Alabama Mitchell Cancer Institute — Mobile
Alaska
- Katmai Oncology Group — Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,550 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03281954
The ClinicalTrials.gov registry entry for NCT03281954 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03281954 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arkansas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03281954 about?
NCT03281954 is a clinical study titled "Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo". The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medica...
What is the current status of trial NCT03281954?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,550 participants. The study started on 2017-12-19. Estimated completion is 2027-11-30.
What conditions does trial NCT03281954 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03281954?
The interventions under investigation include: Placebo (DRUG), Atezolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03281954?
This trial is sponsored by NSABP Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03281954 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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