From OHC

May 9, 2024

At OHC, we’re constantly seeking new and innovative ways to combat breast cancer. We’re thrilled to announce our participation in an exclusive groundbreaking Phase 3 clinical trial evaluating a novel HER2-positive breast cancer vaccine, GLSI-100 (GP2 + GM-CSF). This unique trial (FLAMINGO-01), accessible to eligible patients right here in Cincinnati only at OHC, represents a significant step forward in the fight against recurrence and underscores OHC’s commitment to offering our patients innovative and potentially life-saving solutions.

Understanding the HER2/neu Protein and Recurrence Risk

Breast cancer is a diverse disease, and HER2-positive breast cancer is a specific subtype characterized by the overexpression of the HER2/neu protein. This protein fuels cancer cell growth and makes the cancer more aggressive. OHC medical oncologist, hematologist, and principal investigator for this study, Roma Srivastava, MD adds, “Breast cancer remains the most common malignancy in females after skin cancer. So far, we have made immense progress in the treatment of breast cancer, but HER2-positive breast cancer remains a therapeutic challenge.”  She continues, “HER2-positive breast cancer patients have a 25-30% risk of recurrence in the first 10 years after initial treatment, and HER2-positive breast cancer accounts for 30% of all breast cancers diagnosed, so this is a large population of patients affected.”

This recurrence risk can be particularly high for patients with residual disease or those with a high pathologic complete response (pCR) after both neoadjuvant and post-operative adjuvant standard of care treatment.

The Promise of A Vaccine

GLSI-100 is a unique investigational vaccine designed to target HER2-positive cancer cells. Unlike the traditional monoclonal antibody therapy, immunization holds the promise of modulating the immune system by targeting specifically HER2/neu-expressing cancer cells. This allows sustained response without requiring recurrent therapy.

Dr. Srivastava adds that this trial is a critical breakthrough for this specific group of patients, stating, “This is a very exciting time in the research of fighting HER2/neu positive breast cancer because this trial holds promise for the high-risk population at high risk of recurrence. The goal of treatment is to prolong breast cancer-free survival. As per the available results of the Phase 2 study, the estimated 5-year disease-free survival rate was 100% in the vaccine-treated patients, which is very encouraging.”

Why Is This Trial Significant?

This Phase 3 trial represents a significant step forward in the fight against HER2-positive breast cancer recurrence. There are a few factors that make this trial particularly exciting for the cancer community.

  • Local access: OHC, being one of only 37 participating sites nationwide, provides convenient access for eligible patients in the Greater Cincinnati region, eliminating the need to travel to distant locations.
  • A personalized approach: The trial focuses on patients with a high risk of recurrence, potentially offering a more targeted approach for those who need it most.
  • First-of-its-kind: This is the first Phase 3 clinical trial evaluating a HER2-positive vaccine for this specific patient population.
  • Promising early data: Early-phase data suggests that GLSI-100 may be effective in reducing recurrence rates.

How to Participate

If you’ve been diagnosed with HER2-positive breast cancer and are interested in learning more about the GLSI-100 clinical trial, please reach out to our OHC team and schedule an appointment.  This is a unique opportunity to participate in a groundbreaking research endeavor and potentially contribute to the future of breast cancer treatment, all while receiving the personalized care and support you deserve.

While the results of this trial are still pending, the potential impact of GLSI-100 is significant. This vaccine, if proven effective, could offer a powerful new tool for preventing HER2-positive breast cancer recurrence, ultimately saving lives. At OHC, we remain committed to providing our patients with access to the latest advancements in cancer care. Participating in this novel trial is a testament to that commitment, and it represents another way that OHC is surrounding you with everything you need to beat cancer.

To learn more about our clinical trial offerings, schedule an appointment, or request a second opinion, visit or call 888-649-4800.

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