Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Early- Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (RECOVER)

Official Title

Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)

Summary:

The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to prevent and reduce Neutropenia that is associated with cancer chemotherapy.

Trial Description

Primary Outcome Measures :

  • Duration of severe neutropenia (DSN) in Cycle 1
  • Secondary Outcome Measures :
  • Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
  • Depth of ANC Nadir, defined as the patient's lowest ANC in Cycle 1
  • Incidence of Febrile Neutropenia (FN) in patients during Cycle 1
  • This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 with pegfilgrastim in breast cancer patients treated with TC chemotherapy to prevent and reduce Neutropenia.

    Approximately 218 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment arms:

    Each cycle will be 21 days. Total 4 cycles will be evaluated for this study. On Day 1 of each cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will received study drug (SPI-2012 or pegfilgrastim).

    After cycle 1, as applicable, patients who have received at least one dose of study drug will be followed for 12 months after the last dose of study treatment for safety.

    View this trial on ClinicalTrials.gov

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    Resources

    Canadian Cancer Society

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