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NCT03281954 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
A Phase 3 study of Triple Negative Breast Cancer, sponsored by NSABP Foundation.
- Active
- Registry status
- Phase 3
- Development phase
- 1,550
- Enrollment target
- 20
- Study locations
NCT03281954 is a Phase 3 study of Triple Negative Breast Cancer that is active but no longer recruiting, run by NSABP Foundation. The registered enrollment target is 1,550 participants, above the 233-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (565% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT03281954, a Phase 3 study of Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by NSABP Foundation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,550 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,550 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 233-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (565% higher). The listed sponsor is NSABP Foundation, which has 44 total studies on file at ClinicalTrials.gov.
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.
NCT03281954 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arkansas, Alabama.
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.
What interventions are being tested in trial NCT03281954?
The interventions under investigation include: Placebo (DRUG), Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT03281954?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.