Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim

Browse trials for

• Breast Neoplasms 12,544
• Neutropenia 396

Keywords

• Pegfilgrastim
• G-CSF
• neutropenia
• breast cancer
• myelosuppressive chemotherapy

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 308 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Study arms

• Experimental
  LA-EP2006

  During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

  Drug: LA-EP2006

• Active comparator
  Neulasta®

  During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.

  Drug: Neulasta®

Interventions

• DrugLA-EP2006

  Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.

  Also known as: pegfilgrastim

• DrugNeulasta®

  Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.

  Also known as: pegfilgrastim, Neulasta

Primary outcomes

1. Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy

   Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9/l (grade 4 neutropenia).

   Time frame: 21 days (Cycle 1 of chemotherapy treatment)

Secondary outcomes

1. Incidence of Febrile Neutropenia (FN)

   FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) \< 0.5 × 10\^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN ("febrile neutropenia", "neutropenic sepsis") were taken into account.

   Time frame: across all cycles (18 weeks)

2. Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles

   Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.

   Time frame: across al cycles (18 weeks)

3. Depth of ANC Nadir in Cycle 1

   The depth of ANC nadir was defined as the patient's lowest ANC (10\^9 cells/L) in Cycle 1.

   Time frame: Cycle 1 (3 weeks)

4. Number of Patients With ANC Nadir Per Day in Cycle 1

   Numbers of patients with ANC nadir based per day during Cycle 1 are given.

   Time frame: Cycle 1 (3 weeks)

5. Time to ANC Recovery in Days in Cycle 1

   Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10\^9 cells/L after the nadir in Cycle 1.

   Time frame: across Cycle 1 (3 weeks)

6. Frequency of Infections by Cycle and Across All Cycles

   The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class "Infections and Infestations".

   Time frame: across all cycles (18 weeks)

7. Mortality Due to Infection

   Number of patients with death due to infections

   Time frame: Study course (19 weeks)

Baseline characteristics

2 further baseline measures are reported on the registry.

Publications

• Blackwell K, Donskih R, Jones CM, Nixon A, Vidal MJ, Nakov R, Singh P, Schaffar G, Gascon P, Harbeck N. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial. Oncologist. 2016 Jul;21(7):789-94. doi: 10.1634/theoncologist.2016-0011. Epub 2016 Apr 18. PubMed 27091420 ↗
• Blackwell K, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Harbeck N. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017 Sep 1;28(9):2272-2277. doi: 10.1093/annonc/mdx303. PubMed 28637287 ↗

Individual participant data

Plan to share: Undecided