HER2/Neu Peptide GLSI-100 for Breast Cancer

Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

Recruiting Phase 3 Interventional Study
Breast Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,250 (estimated)
Sponsor
Greenwich LifeSciences, Inc. · Industry
Who this trial is looking for

This trial is looking for women with HER2 positive breast cancer who are at high risk of the disease returning. Participants will receive a treatment called GLSI-100 through injections over several months.

Are You a Good Fit for This Trial?
Rules you out Stage IV cancerInflammatory breast cancerActive infection

You may be able to join if

  • I have been diagnosed with HER2 positive breast cancer.
  • I have completed both neoadjuvant and adjuvant trastuzumab-based therapies.
  • I have residual invasive cancer after surgery or a complete response to treatment.
  • I can start the study therapy within one year of finishing standard treatments.
  • I do not have any signs of remaining breast cancer.
  • I have a good performance status (ECOG 0-2).
  • I have adequate organ function.
  • I am not pregnant or am post-menopausal.

You may not be able to join if

  • I have stage IV or metastatic breast cancer.
  • I have inflammatory breast cancer.
  • I am receiving other investigational treatments.
  • I am currently receiving chemotherapy.
  • I need long-term treatment with corticosteroids.
  • I have an autoimmune disease.
  • I have had serious allergic reactions to certain treatments.
  • I have an active infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied at diagnosis (multifocal, multicentric, or synchronous contralateral disease) * Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer th…
Contacts

Jaye L Thompson, Ph.D.

(832) 791-2542

Jaye.Thompson@GreenwichLifeSciences.com

CONTACT