Participant flow

SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide · Source last updated 2022-03-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

   id

   FG000

   title

   (Arm 1): SPI-2012 and TC

2. description

   At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

   id

   FG001

   title

   (Arm 2): Pegfilgrastim and TC

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Investigator Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         14

      type

      Initiated Non-Protocol Therapy

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Myeloid Growth Factors Treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         9

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Sponsor decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Reason not specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         119

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         117

      2. group Id

         FG001

         num Subjects

         118

      comment

      Safety Population includes all participants who receive at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim).

      type

      Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         117

      2. group Id

         FG001

         num Subjects

         118

      comment

      Safety Follow-up Period included all participants who received at least one dose of any protocol specified drug (TC or SPI-2012 or pegfilgrastim) and continued for 12 months after last study treatment.

      type

      Entered Safety Follow-up Period

   4. achievements

      1. group Id

         FG000

         num Subjects

         96

      2. group Id

         FG001

         num Subjects

         85

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         34

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 237 participants were randomized into study, 118 participants in Arm 1 (SPI-2012 and TC) and 119 participants in Arm 2 (Pegfilgrastim and TC). 235 participants were treated, out of which 181 participants completed the study. All participants who received at least one dose of study drug (treatment period) entered the safety follow-up period.

recruitment Details

This study was conducted at 74 sites in the United States, Canada, Hungary, Poland, India, Korea from 10 May 2017 to 06 May 2019. The study was conducted in two periods: treatment period (first dose of TC until 35 (± 5) days after last dose of treatment) and safety follow-up period (End of Treatment Visit through 12 months after last dose of study treatment).

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Preserved source evidence · Not medical advice