Breast Cancer
Conditions
Keywords
HER2/neu positive, Residual disease, pCR, Extended adjuvant, GP2, Immunotherapy, HLA type
Brief summary
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.
Interventions
BIOLOGICALPlacebo
0.9% Normal Saline
BIOLOGICALGLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF
Sponsors
Greenwich LifeSciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Subjects will be randomized to GLSI-100 or placebo. 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, which has closed to enrollment, will explore GLSI-100 immunotherapy in subjects without the HLA-A\*02 allele.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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 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 at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy * 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.
Exclusion criteria
* 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: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Breast Cancer-free Survival (IBCFS) | Median 4 years of follow-up (interim analyses planned) | IBCFS is defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality (STEEP version 2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Disease-free Survival (IDFS) | Median 4 years of follow-up (interim analysis planned) | IDFS is defined as the time from randomization (or first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or any cause mortality (STEEP version 2). |
| Distant Disease-free Survival (DDFS) | Median 4 years of follow-up (interim analysis planned) | DDFS will be defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) to the time of distant disease recurrence or death. |
| Overall Survival | Median 4 years of follow-up (interim analysis planned) | Overall survival will be defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) until death from any cause. |
| Quality of Life Questionnaire Core 30 (QLQ-C30) | Baseline and 36 months | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) |
| Quality of Life FACT-GP5 | Baseline and 36 months | FACT-GP5 to assess global side effect impact |
Countries
Belgium, France, Germany, Ireland, Italy, Poland, Portugal, Romania, Spain, United States
Contacts
CONTACTJaye L Thompson, Ph.D.
PRINCIPAL_INVESTIGATORMothaffar F Rimawi, MD
Baylor College of Medicine
Outcome results
None listed