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RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well GLSI-100 works and how safe it is for people with HER2-positive breast cancer, which has high levels of a protein called HER2. It is for people at high risk of cancer coming back who have finished standard treatment before and after surgery. GLSI-100 is a treatment that uses the immune system and is given as shots into the skin.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All breast tumors tested at diagnosis must be confirmed as HER2-positive by tissue testing.
  • Must have finished standard breast cancer treatment with trastuzumab before and after surgery.
  • Must have had stage I, II, or III cancer with cancer still found in the breast or armpit lymph nodes at surgery after treatment; or stage III cancer with no cancer found at that surgery.
  • Must start study treatment within one year after finishing trastuzumab treatment after surgery and other standard treatments. Hormone treatment may continue.
  • Your doctor must find no signs of breast cancer still present now.
  • Must be able to care for yourself and be out of bed or a chair for at least half the day, with organs working well enough.
  • Must have a negative pregnancy test or have gone through menopause. If able to become pregnant, must agree to use highly effective birth control.
  • Must live in, and have received cancer treatment in, the country where the study site is located.

Who can't join

  • Have ever had stage IV breast cancer or breast cancer that spread to distant parts of the body, or have inflammatory breast cancer.
  • Are receiving chemotherapy or another experimental treatment.
  • Need long-term steroid treatment that affects the whole body or other treatment that weakens the immune system.
  • Have a history of a weak immune system or an active disease in which the immune system attacks the body.
  • Have had a serious allergic reaction to GM-CSF medicines such as sargramostim, yeast-based products, or any study treatment ingredient.
  • Have had another cancer, except adequately treated early cervical cancer that has not spread or basal cell or squamous cell skin cancer.
  • Have an active infection.
  • Have HIV with a detectable amount of virus in the blood within six months before starting treatment. People taking effective HIV medicines with no detectable virus during that period may join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (51)

AL

AZ

CA

CO

CT

DC

FL

GA

IL

MA

  • Massachusetts General Hospital Cancer Center · Boston, MA 02114MGH Cancer Center New Patient Access Team · Study contact · 877-394-5128Laura Spring, MD · Principal investigatorMore trials in Boston

MD

MN

MO

NE

NJ

NV

NY

OH

OR

PA

TN

TX

UT

VA