Lead Sponsor

Aston Sci. Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Has a residual invasive cancer in the breast(non-pCR) after neoadjuvant treatment
•Has stage I, II, or III disease prior to surgery per American Joint Committee on Cancer (AJCC)
•HER 2 1+ by IHC or HER2 2+by IHC without gene amplification by ISH, as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
•Hormone receptor (ER and PR) negative by ASCO/CAP guidelines
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Demonstrates adequate organ function.

•Has a history of hypersensitivity or other contraindications to rhGM-CSF
•Has a history of invasive malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or carcinoma in situ.
•Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
•Has a history of autoimmune disease or inflammatory disease
•Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
•Is pregnant or breastfeeding or expecting to conceive children

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