Phase 2
Completed N=60
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
Source: ClinicalTrials.gov NCT01569087 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Oct 2016
Primary outcomePrimary: CTCAE Grade 3/4 Neutropenia Incidence — 18; 13; 11 participants — p=<0.05
Summary
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CTCAE Grade 3/4 Neutropenia Incidence |
18; 13; 11 | <0.05 sig |
| SECONDARY Mean Duration of CTCAE Grade 4 Neutropenia |
0.43; 0.40; 0.33 | — |
| SECONDARY The Duration of Any Grade Neutropenia |
1.86; 1.0; 0.78 | — |
| SECONDARY Low Level (Nadir) ANC x 10^9/L |
0.57; 0.75; 0.82 | — |
| SECONDARY Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy |
4.8; 3.8; 3.00 | — |
| SECONDARY Incidence of Febrile Neutropenia |
1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent form;
- Histologically verified diagnosis of stage IIb/III/IV breast cancer;
- Age of 18-70 years inclusive;
- If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
- ECOG Performance Status of 0, 1 or 2, not increasing within during 2 weeks before randomization;
- ANC level of 1500/μL and more at the beginning of the study
- Platelet count of 100 000/μL and more at the beginning of the study
- Hemoglobin level of 90 g/l and more
- Creatinine level 50% and more;
- If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 500 mg/m2 for doxorubicin or 500 mg/m2 for epirubicin;
- Ability of the participant to follow the protocol requirements, according to the Investigator's opinion;
- Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug.
Exclusion Criteria
- Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
- Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
- Pregnancy or breastfeeding;
- Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
- Concomitant radiotherapy (except selective radiotherapy of bone metastases);
- Surgery, radiotherapy (except selective radiotherapy of bone metastases), administration of any experimental drugs within 30 days prior randomization;
- History of bone marrow/stem cell transplantation;
- Conditions limiting the patient's ability to follow the protocol;
- CTCAE grade 2/4 neuropathy
- HIV, HCV, HBV, T.Pallidum infection(s);
- Acute or active chronic infections.
Data sourced from ClinicalTrials.gov (NCT01569087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.