A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.

A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:

1. Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF

2. Prior autologous stem cell harvest of any type

3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents

4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin

5. For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction

6. Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years

7. Known HER2 + ( overexpressing breast cancer)

8. Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer

9. ≥ Grade 2 underlying neuropathy

10. Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections

11. Treatment with systemically active antibiotics within 72 hours before chemotherapy

12. Known infection with HIV

13. Known sickle cell disease

14. Known severe persistent drug-induced myelosuppression

15. New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130

16. Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130

17. Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product

18. Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study

19. Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130

20. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication

What this study is about