Phase 3
N=316
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
Neutropenic Complications · Breast Neoplasms · Chemotherapy-induced Neutropenia · Chemotherapeutic Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT01735175 ↗Enrolled (actual)
316
Serious AEs
11.7%
Results posted
Jun 2017
Primary outcome: Primary: Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy — 0.75; 0.83; 0.75; 0.79 days — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LA-EP2006 (Drug); Neulasta® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sandoz
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy |
0.75; 0.83; 0.75; 0.79 | 0.05 |
| SECONDARY Incidence of Febrile Neutropenia (FN) |
6; 11; 2; 1; 2; 1 | — |
| SECONDARY Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles |
9; 14; 6; 2; 7; 6 | — |
| SECONDARY Depth of ANC Nadir in Cycle 1 |
1.102; 0.921 | — |
| SECONDARY Number of Patients With ANC Nadir Per Day in Cycle 1 |
5; 5; 7; 4; 101; 104 | — |
| SECONDARY Time to ANC Recovery in Days in Cycle 1 |
1.58; 1.72 | — |
| SECONDARY Frequency of Infections by Cycle and Across All Cycles |
7; 4; 6; 5; 3; 8 | — |
| SECONDARY Mortality Due to Infection |
0; 2; 159; 155 | — |
Summary
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Eligibility Criteria
Inclusion Criteria
- histologically proven breast cancer
- eligible for six cycles of neoadjuvant or adjuvant chemotherapy
Exclusion Criteria
- concurrent or prior chemotherapy for breast cancer
- concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
- concurrent prophylactic antibiotics
- previous therapy with any G-CSF (granulocyte-colony stimulating factor) product
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01735175). 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.