Information sheet on the clinical study - Flamingo-01 Phase III study

Main indication

Breast cancer

 

Study name (study type)

FLAMINGO-01 - Phase III study

Study sponsor

GERMAN BREAST GROUP

Registration number

FOR RAPID READERS:

Flamingo-01 is a clinical, randomized, double-blind, multicenter Phase III adjuvant immunotherapy trial with GLSI-100 to prevent the recurrence of breast cancer in HER2+ and HLA-A*02+ patients after the first year of adjuvant treatment with trastuzumab.

DETAILED INFORMATION:

Further details to follow

Study Title

Evaluation of the efficacy of GLSI-100 compared to placebo in patients with HLA-A*02-positive and HER2-positive breast cancer who are at high risk of recurrence and have completed both neoadjuvant and postoperative adjuvant standard trastuzumab-based therapy. 

Which conditions are being treated in this study?

Breast cancer

Are specific subgroups of patients with one of the mentioned conditions being treated?

Patients with HER2-positive and HLA-A*02-positive breast cancer

Background on the study medication

GLSI-100 is a combination of GP2 (a nine-amino-acid peptide of the Herz2neu protein) and GM-CSF (granulocyte-macrophage colony-stimulating factor, which stimulates the immune response against Herz2neu-expressing cancer cells)

Study Protocol

Further details to follow

Inclusion criteria

• Patients with stage I, II, or III disease at initial diagnosis and evidence of residual invasive tumor in the breast or axillary lymph nodes following neoadjuvant therapy 
• or
• Patients with stage III disease at initial diagnosis who achieve pathological complete remission following neoadjuvant therapy
• Patients with histologically confirmed HER2-positive early-stage breast cancer and HLA-A*02 positivity 
• Patients following primary standard therapy

Exclusion criteria

• Patients with stage IV breast cancer, metastatic breast cancer, or inflammatory breast cancer
• The patient is currently participating in another clinical trial and is receiving active treatment

Your contacts: Investigators at the center and contact information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Phone: 06142 88-1223

Staff members in charge at the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032