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.
Condition: Non-metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: HSP-130
Intervention description: Dosage will vary per each cohort: (Five independent cohorts) Cycle 0 Regimen A - 3 mg Cycle 0 Regimen B - 6 mg Cycles 1-4 Regimen B - 6 mg Cycles 1-4 Regimen A (Potential)- 3 mg Cycles 1-4 Regimen C (Conditional)- 12 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSP-130 Phase 1-2 Study in patients with Breast cancer

Summary:

      This is a study of how one or more injections of HSP-130 under the skin effect the white
      blood cell counts and drug levels in women with breast cancer that has not spread to distant
      sites in the body (non-metastatic). This will be studied in women before breast surgery or
      while receiving chemotherapy. Safety will also be studied.

      Additionally, the purpose of this study is to evaluate the effects and safety of single and
      multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will
      determine the dose to move forward for future clinical trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject will be eligible for study participation if all of the following criteria
             are met at Screening:

               1. Is informed, has been given ample time and opportunity to read about
                  participation in the study and has signed and dated the written informed consent
                  form approved by an Independent Ethics committee (IEC) prior to any study related
                  activities

               2. Females ≥ 18 years

               3. Histologically confirmed and documented invasive breast cancer

               4. Breast cancer without evidence of distant metastases (Stage 4) based on staging
                  work-up

               5. Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting
                  and who are candidates for chemotherapy in the adjuvant setting of
                  taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy

               6. Zubrod/WHO/ECOG performance status ≤ 2

               7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by:

                    1. Hemoglobin ≥ 10 mg/dl

                    2. ANC ≥ 1.5 x 10^9/L

                    3. Platelet count of ≥ 100 x 10^9/L

                    4. Total bilirubin ≤ 2 mg/dl

                    5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x
                       the upper limit of normal (ULN) of the reference lab

                    6. Serum creatinine of ≤ 1.5 x ULN for reference lab or estimated glomerular
                       filtration rate (eGFR) of ≥ 60 mg/min

               8. Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive

               9. Subjects of childbearing potential, and their partners, agree to pregnancy
                  prevention throughout the duration of the study (through the Follow-up Visit).
                  Specific type of pregnancy prevention should be discussed with, and acceptable
                  to, the treating oncologist in the context of the tumoral hormone receptor
                  status. Subjects and their partners must agree to use of an effective method of
                  contraception, to avoid impregnation of females throughout the course of the
                  study

                  Medically acceptable forms of birth control can include, with approval of the
                  treating physician:

                    1. Barrier methods (condom or diaphragm with spermicide)

                    2. Intrauterine device (IUD)

                    3. Hormone contraceptives (such as oral [pill], injection, skin patch, implant,
                       cervical ring)

                    4. Subjects using oral contraceptives must be on a stable regimen for at least
                       3 months prior to Screening. Sexually active subjects must use contraception
                       while on HSP-130 from admission to the final Follow-up Visit

              10. Able to understand verbal or written instructions and comply with all study
                  requirements, to communicate effectively with study personnel and is available
                  for the planned duration of the study

        Exclusion Criteria:

          -  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