Statement: Patients with Class III obesity cannot be included in the primary trial, but can be entered into the secondary trial, as long as they do not have uncontrolled Hypertension.
Primary_evidence: Inclusion Criteria:   A subject will be eligible for study participation if all of the following criteria are met at Screening:   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   Females  18 years   Histologically confirmed and documented invasive breast cancer   Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up   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   Zubrod/WHO/ECOG performance status  2   Adequate bone marrow, hepatic, and renal function reserve as evidenced by:   Hemoglobin  10 mg/dl   ANC  1.5 x 10^9/L   Platelet count of  100 x 10^9/L   Total bilirubin  2 mg/dl   Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)  3 x the upper limit of normal (ULN) of the reference lab   Serum creatinine of  1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of  60 mg/min   Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive   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:   Barrier methods (condom or diaphragm with spermicide)   Intrauterine device (IUD)   Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring)   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   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:   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   Prior autologous stem cell harvest of any type   Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents   Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin   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   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   Known HER2 + ( overexpressing breast cancer)   Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer    Grade 2 underlying neuropathy   Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections   Treatment with systemically active antibiotics within 72 hours before chemotherapy   Known infection with HIV   Known sickle cell disease   Known severe persistent drug-induced myelosuppression   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   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   Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product   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   Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130   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
Secondary_evidence: Inclusion Criteria:   Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.   Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).   Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.   Male or female, 18 years of age or older.   ECOG performance status 0 or 1.   Adequate organ function as defined in the protocol. Exclusion Criteria:   Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.   Metastatic (Stage IV) breast cancer   Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.   Current therapeutic treatment on another clinical trial with an investigational agent.   Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus   Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.   Hypertension that cannot be controlled by medications.   Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.   Known human immunodeficiency virus (HIV) infection.   Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.   Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.