A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects with Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel) - NA

• Conditions: breast cancer patients receiving myelosupressive chemotherapy (doxorubicin/docetaxel); MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2010-019001-42-BG
• Lead Sponsor: Teva Pharmaceutical Works Private Limited Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients with histologically or cytologically confirmed breast cancer scheduled
to receive doxorubicin 60 mg/m2 and docetaxel 75 mg/m2
2. 18 years of age or older
3. Adequate hematologic function: ANC >/= 1.5 x 10 9/L; Platelets >/= 100 x10 9/L
4. Adequate hepatic and renal function:Serum creatinine < 2.0 mg/dL; Total bilirubin within normal limits; Serum transaminases - SGOT and SGPT < 1.5 x upper
limit normal; Alkaline phosphatase < 2.5 x upper limit normal
5. ECOG performance status 0 - 2
6. Eligible to receive doxorubicin based on a left ventricular ejection fraction
(LVEF) >/= lower limit of normal for the local institution
7. Have the ability to understand the requirements of the study, provide written
informed consent (including consent for the use and disclosure of researchrelated
health information), and comply with the study protocol procedures
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than 1 prior chemotherapy regimen (including adjuvant therapy if given
within the last 12 months prior to study chemotherapy)
2. Prior lifetime cumulative anthracycline dose exceeding 240 mg/m2 doxorubicin
or the equivalent dose of another anthracycline or anthracenedione
3. Prior chemotherapy/immunotherapy within 30 days prior to study
chemotherapy (within 6 weeks of study chemotherapy for nitrosoureas (BCNU,
CCNU) or mitomycin-C)
4. Concomitant trastuzumab (Herceptin)
5. Received any investigational agent within 30 days prior to study chemotherapy
6. Myocardial infarction within 6 months prior to study chemotherapy,
uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG
abnormalities that may interfere with the accurate assessment of the QT
interval, including intraventricular conduction delays (QRS >120 msec) and
complete bundle branch blocks
7. Prior surgery within 2 weeks of study chemotherapy
8. Prior radiation therapy within 4 weeks of study chemotherapy (except spot
irradiation for bone metastases)
9. Prior high-dose chemotherapy with hematopoietic stem cell transplant
10. Prior use of G-CSF, GM-CSF or erythropoietin within 4 weeks of study
chemotherapy
11. Received systemic antibiotics within 72 hours of study chemotherapy
12. History of myeloid malignancy or myelodysplasia
13. Known brain metastases unless adequately treated (surgery or radiotherapy), no
evidence of progression with a minimum of 3 weeks observation and
neurologically stable off anticonvulsants and steroids.
14. Known sickle cell disease
15. Diagnosis of ARDS
16. Known history of allergies to yeast-derived products
17. Known hypersensitivity to E. coli-derived proteins‚ pegfilgrastim‚ filgrastim, or
any other component of pegfilgrastim
18. History of severe hypersensitivity reactions to docetaxel or other drugs
formulated with polysorbate 80 such as etoposide and vitamin E
19. Hypersensitivity to doxorubicin, any of its excipients, or other anthracyclines or
anthracenediones
20. Pregnant female or nursing mother. All non-sterile or non-postmenopausal
females must have a negative serum pregnancy test at screening and must
practice a medically accepted method of contraception over the course of the
study and for 30 days after the last dose of study drug (acceptable methods of
birth control in this study are: surgical sterilization, intrauterine devices, oral
contraceptive, contraceptive patch, long-acting injectable contraceptive,
partner’s vasectomy, a double-protection method (condom or diaphragm with
spermicide). Hormonal contraception must be accompanied by an additional
barrier method of birth control (condom).
21. Males who do not agree to use effective contraception throughout the study and
for a period of 30 days after the last dose of study drug
22. Known HIV positive or active hepatitis (Patients with unknown status will not
be tested)

Study & Design

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