A study designed to compare safety and efficacy of RGB-02 and Neulasta® in breast cancer patients receiving chemotherapy

• Conditions: eutropenia and febrile neutropenia in patients being treated with cytotoxic chemotherapy for malignancy.; MedDRA version: 16.0Level: PTClassification code 10029354Term: NeutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 16.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-003166-14-CZ
• Lead Sponsor: Gedeon Richter Plc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-30
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1. Females = 18 and = 65 years of age.
2. Patients with invasive breast cancer (Stage IIB and III) appropriate for treatment with doxorubicin and docetaxel combination therapy in the neoadjuvant or adjuvant treatment setting.
3. ECOG performance status 0 or 1.
4. Chemotherapy naïve.
5. Adequate bone marrow function assessed during Screening, as indicated by:
a. ANC = 1.5 x10^9/L,
b. Platelet count = 100 x10^9/L, and
c. Hemoglobin > 8 g/dL.
6. Adequate renal and hepatic function assessed during Screening, as indicated by:
a. Estimated creatinine clearance = 50 mL/min calculated by the Cockcroft-Gault method,
b. Bilirubin, aspartate transaminase, alanine transaminase < 1.5 x upper limit of normal (ULN), and
c. Alkaline phosphatase < 2.5 x ULN.
7. Female patients with childbearing potential must have a negative urine pregnancy test within 3 days prior to the first dose of chemotherapy (Day 1 of Cycle 1) and must agree to use 2 reliable methods of contraception throughout the treatment period and for 3 months after discontinuation of treatment. The 2 methods of reliable contraception must include 1 highly effective method (intrauterine device, hormonal pills, injections or implants, tubal ligation, partner’s vasectomy), and 1 additional effective (barrier) method (diaphragm, cervical cap, male condom). True abstinence is acceptable when this is in line with the patient’s preferred and usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
8. Written informed consent given before any study-related assessment is performed.
9. Patient is able and willing to co-operate with the requirements of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Pregnant or breast-feeding women.
2. Co-existing active infection, or received systemic anti-infectives within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1).
3. Significant cardiovascular disease defined as any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current uncontrolled angina pectoris, current clinically significant valvular disease, current evidence of transmural infarction on ECG, or any other significant cardiovascular disease which in the Investigator’s judgment contraindicates the planned therapy (especially doxorubicin).
4. Any malignancy other than the current breast cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
5. Radiation therapy within 4 weeks prior to randomization into this study.
6. Concurrent anti-cancer therapy, including endocrine therapy, immunotherapy and monoclonal antibody therapy, and any concurrent treatment with bisphosphonates.
7. Prior bone marrow or stem cell transplantation.
8. Sickle cell disease.
9. Other investigational drug administration within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1).
10. Previous exposure to filgrastim, lenograstim, or pegfilgrastim.
11. Known allergy to any of the study drugs, including chemotherapy agents.
12. Contraindication for use of corticosteroids.
13. Systemic corticosteroid therapy within 2 weeks prior to randomization into this study. The use of topical or inhaled corticosteroids within 2 weeks prior to randomization may be allowed at the discretion of the Investigator.
14. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the study.

Study & Design

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