NCT05159778: Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)

Breast Cancer Type: HR+ & HER2-negative
Hormone Mutations: ER+, PR+
Other Mutations: 
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 2
Drug Category: Immunotherapy, Therapeutic Antibody

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: 
Additional Notes: Patient must have progressed on at least one hormone therapy – AI or SERD (e.g. Arimidex/anastrozole, Aromasin/exemestane, Femara/letrozole, Faslodex/fulvestrant, Zoladex, Lupron) + CDK 4/6 inhibitor (e.g. Ibrance/palbociclib, Verzenio/abemaciclib, Kisqali/ribociclib) and alpelisib if PIK3CA mutated) & up to two lines of prior chemotherapy (i.e., capecitabine, taxanes); Patient may have progressed after any number of hormone therapies alone or combined with small molecule inhibitors, (i.e., mTOR, PIK3CA, CDK 4/6, etc.)
Exclusions: Patients with bone only metastases; Patients with prior exposure to Imprime PGG and/or anti-PD1/L1/L2 agents (e.g. Keytruda/pembrolizumab, Tecentriq/atezolizumab); Patients with symptomatic, untreated, unstable brain and/or leptomeningeal metastases that require treatment

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