Phase 3
Completed N=406
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
Source: ClinicalTrials.gov NCT02643420 ↗Enrolled (actual)
406
Serious AEs
9.3%
Results posted
Mar 2022
Primary outcomePrimary: Duration of Severe Neutropenia (DSN) in Cycle 1 — 0.20; 0.35 days — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to compare the efficacy of a single dose 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) in Cycle 1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe Neutropenia (DSN) in Cycle 1 |
0.20; 0.35 | <0.0001 sig |
| SECONDARY Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 |
3.24; 3.49 | 0.685 |
| SECONDARY Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1 |
2.56; 2.53 | 0.155 |
| SECONDARY Number of Participants With Febrile Neutropenia (FN) in Cycle 1 |
4; 2 | 0.435 |
| SECONDARY Duration of Severe Neutropenia in Cycle 2, 3 and 4 |
0.13; 0.09; 0.11; 0.08; 0.11; 0.09 | <0.0001 sig |
| SECONDARY Number of Participants With Neutropenic Complications in Cycle 1 |
8; 8 | 1.000 |
| SECONDARY Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4 |
1; 1; 4; 1; 2; 0 | 1.000 |
| SECONDARY Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4 |
99.1; 98.1; 99.3; 99.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
192; 204; 95; 83; 36; 29 | — |
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 neoadjuvant TC chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
- Platelet count ≥ 100×10^9/L
- Hemoglobin > 9 g/dL
- Creatinine clearance > 50 mL/min
- Total bilirubin ≤ 1.5 mg/dL
- Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5× Upper Limit of Normal (ULN).
- 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 or metastatic breast cancer
- Known sensitivity to E. coli -derived products or to any products to be administered during dosing
- 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 serious underlying medical condition that would impair ability to receive protocol treatment
- Prior bone marrow or stem cell transplant
- Use of 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 (NCT02643420). 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.