Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects (NCT05232916)
A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)
🩺 Plain-English Summary (8th-Grade Level)
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A\*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects.
Who can join: Review the eligibility criteria below.
Location: Southern Cancer Center — Mobile, Alabama
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (179 Sites)
Showing the first 25 of 179 sites.
- Southern Cancer Center — Mobile, Alabama
- City of Hope - Cancer Center Phoenix — Goodyear, Arizona
- Tucson Medical Center HealthCare — Tucson, Arizona
- City of Hope - Duarte Cancer Center — Duarte, California
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center — Fullerton, California
- City of Hope - Orange County Lennar Foundation Cancer Center — Irvine, California
- University of California San Diego - Moores Cancer Center — La Jolla, California
- University of Southern California - Norris Comprehensive Cancer Center — Los Angeles, California
- Stanford Medicine Cancer Center - Stanford Women's Cancer Center — Palo Alto, California
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco, California
- University of California Los Angeles - Hematology / Oncology Parkside — Santa Monica, California
- PIH Health Hospital - Whittier Hospital — Whittier, California
- Rocky Mountain Cancer Centers — Denver, Colorado
- Yale Cancer Center - Smilow Cancer Hospital — New Haven, Connecticut
- Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital — Washington D.C., District of Columbia
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- City of Hope - Cancer Center Atlanta — Newnan, Georgia
- Northwestern University - Northwestern Memorial Hospital — Chicago, Illinois
- City of Hope - Cancer Center Chicago — Zion, Illinois
- Maryland Oncology Hematology — Annapolis, Maryland
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts
- Minnesota Oncology — Maple Grove, Minnesota
- Siteman Cancer Center - Washington University Medical Campus — St Louis, Missouri
- Nebraska Cancer Specialists — Omaha, Nebraska
📞 Contact the Study Coordinator
Phone: (832) 791-2542
Email: Jaye.Thompson@GreenwichLifeSciences.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
More studies in Breast Cancer
- S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer — Anniston, Alabama
- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer — Chicago, Illinois
- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
Explore by condition: All Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.