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Tests treatment safety and results for Breast Cancer
Official title Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
ClinicalTrials.gov ID: NCT05232916
What this study is testing
What is GLSI-100?
GLSI-100 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- HLA-A\ 02-positive, unless being enrolled in the third non-HLA-A\ 02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied (multifocal, multicentric, or synchronous...
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease)...
- The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study...
You likely can't join if
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy
- History of immunodeficiency or active autoimmune disease
See the full eligibility criteria
- HLA-A\ 02-positive, unless being enrolled in the third non-HLA-A\ 02 arm
- Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied (multifocal, multicentric, or synchronous contralateral disease)
- Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
- Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -OR- Stage III...
- The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study therapy can be administered concurrently with endocrine therapy.
- No clinical evidence of residual or persistent breast cancer per treating physician assessment
- ECOG 0-2
- Adequate organ function
- Negative pregnancy test or evidence of post-menopausal status
- If of childbearing potential, willing to use a form of highly effective contraception
- Subject must both reside in and have been treated for their cancer in the country in which the clinical site is located.
- Stage IV cancer or metastatic breast cancer at any time
- Inflammatory breast cancer
- Receiving other investigational agents
- Receiving chemotherapy
- Requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy
- History of immunodeficiency or active autoimmune disease
- A history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product
- Other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
- Active infection
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: people on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Goodyear, Arizona, United States
- Tucson, Arizona, United States
- Duarte, California, United States
- Fullerton, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Whittier, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Newnan, Georgia, United States
- Chicago, Illinois, United States
- Zion, Illinois, United States
+ 141 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Goodyear, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; Fullerton, California, United States; Irvine, California, United States and 155 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.