๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-04-04

Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo (NCT03281954)

A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: NSABP Foundation Inc

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of South Alabama Mitchell Cancer Institute โ€” Mobile, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (217 Sites)

Showing the first 25 of 217 sites.

  • University of South Alabama Mitchell Cancer Institute โ€” Mobile, Alabama
  • Katmai Oncology Group โ€” Anchorage, Alaska
  • St. Bernard's Medical Center โ€” Jonesboro, Arkansas
  • St. Bernard's Medical Center โ€” Paragould, Arkansas
  • Kaiser Permanente-Anaheim โ€” Anaheim, California
  • Kaiser Permanente-Baldwin Park โ€” Baldwin Park, California
  • Kaiser Permanente-Bellflower โ€” Bellflower, California
  • Arrowhead Regional Medical Center โ€” Colton, California
  • City of Hope โ€” Duarte, California
  • Kaiser Permanente-Fontana โ€” Fontana, California
  • Kaiser Permanente-Harbor City โ€” Harbor City, California
  • Kaiser Permanente-Irvine โ€” Irvine, California
  • Cancer and Blood Specialty Clinic โ€” Los Alamitos, California
  • Kaiser Permanente-Sunset โ€” Los Angeles, California
  • Kaiser Permanente-West Los Angeles โ€” Los Angeles, California
  • Kaiser Permanente-Panorama City โ€” Panorama City, California
  • Kaiser Permanente-Riverside โ€” Riverside, California
  • Kaiser Permanente Medical Group โ€” San Diego, California
  • Kaiser Permanente-Zion โ€” San Diego, California
  • Kaiser Permanente - Otay โ€” San Diego, California
  • Kaiser Permanente- San Marcos โ€” San Marcos, California
  • City of Hope - South Pasadena โ€” South Pasadena, California
  • Torrance Memorial Physician Network โ€” Torrance, California
  • City of Hope - Upland โ€” Upland, California
  • PIH Health โ€” Whittier, California

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—