A study of the safety and effects of one or more doses of HSP-130 injected under the skin in patients with breast cancer that has not spread to distant sites in the body

Phase 1

• Conditions: Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; MedDRA version: 18.1Level: LLTClassification code 10021456Term: Immunodeficiency secondary to oncology chemotherapySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002057-35-ES
• Lead Sponsor: Hospira, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-26
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

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 naïve, 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 or TC as background chemotherapy
6. Zubrod performance status ? 2
7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by:
a. Hemoglobin ? 10 mg/dL
b. ANC ? 1.5 x 109/L
c. Platelet count of ? 100 x 109/L
d. Total bilirubin ? 2 mg/dL
e. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ? 3 x the upper limit of normal (ULN) of the reference lab
f. Serum creatinine of ? 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ? 60 mg/min
8. 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.
9. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1. Previous granulocyte colony stimulating factor (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 Escherichia coli (E. coli) derived proteins, filgrastim, other G CSFs, or pegylated agents
4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin
5. Chemotherapy other than that included in this study (i.e., 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
6. Known HER2+ (overexpressing breast cancer)
7. Known triple negative (estrogen receptor negative, progesterone receptor negative and HER2 negative) breast cancer
8. Medical conditions including but not limited to: Known sickle cell disease; known severe persistent drug induced myelosuppression; severe uncontrolled cardiac disease; any malignancy other than breast with the exception of adequately treated squamous or basal cell carcinoma or the skin or cervical carcinoma in situ within 5 years; pregnancy or lactation; received live, live attenuated, or non live vaccine within 4 weeks
9. Current or recent treatment (within 30 days before the first administration of the HSP 130) with any other Investigational Medicinal Product
10. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified