Phase 3
N=237
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
Neutropenia · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02953340 ↗Enrolled (actual)
237
Serious AEs
7.9%
Results posted
Mar 2022
Primary outcome: Primary: Duration of Severe Neutropenia (DSN) in Cycle 1 — 0.31; 0.39 Days — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPI-2012 (Drug); Pegfilgrastim (Drug); Docetaxel (Drug); Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectrum Pharmaceuticals, Inc
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe Neutropenia (DSN) in Cycle 1 |
0.31; 0.39 | < 0.0001 sig |
| SECONDARY Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 |
3.49; 3.35 | — |
| SECONDARY Depth of ANC Nadir in Cycle 1 |
2.67; 2.06 | — |
| SECONDARY Number of Participants With Febrile Neutropenia (FN) in Cycle 1 |
1; 4 | — |
| SECONDARY Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4 |
0.08; 0.09; 0.07; 0.07; 0.07; 0.08 | — |
| SECONDARY Number of Participants With Neutropenic Complications in Cycle 1 |
1; 5 | — |
| SECONDARY Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4 |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Relative Dose Intensity (RDI) of TC Chemotherapy |
96.9; 98.4; 98.4; 98.8 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death |
115; 116; 33; 48; 12; 19 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).
Eligibility Criteria
Key Inclusion Criteria
- New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
- Candidate for adjuvant or neo-adjuvant TC chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status =1.5×10^9/L
- Platelet count >=100×10^9/L
- Hemoglobin >9 g/dL
- Calculated creatinine clearance > 50 mL/min
- Total bilirubin <=1.5 mg/dL
- Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) <=2.5×ULN (upper limit of normal)
- Alkaline phosphatase <=2.0×ULN
Key Exclusion Criteria
- Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
- Locally recurrent/metastatic breast cancer
- Known sensitivity to E. coli-derived products
- Concurrent adjuvant cancer therapy
- Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
- Active infection, receiving anti-infectives, or any underlying medical condition that would impair ability to receive protocol treatment
- Prior bone marrow or stem cell transplant
- Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study• Radiation therapy within 30 days prior to enrollment
- Major surgery within 30 days prior to enrollment
Data sourced from ClinicalTrials.gov (NCT02953340). 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.