Participant flow

SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) · 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

   Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \[G-CSF\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.

   id

   FG000

   title

   Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)

2. description

   Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.

   id

   FG001

   title

   Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         12

      type

      Initiation of Non-Protocol Therapy for Breast Cancer

   2. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         19

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         10

      type

      Treatment with Additional Myeloid Growth Factors During Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         10

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Investigator Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Sponsor decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         210

      type

      STARTED

   2. achievements

      1. comment

         One participant was randomized to the Arm 2: Pegfilgrastim and TC but was inadvertently administered SPI-2012 on Cycle 1, Day 2 and was included in the Arm 1: SPI-2012 and TC for the Safety Population.

         group Id

         FG000

         num Subjects

         197

      2. group Id

         FG001

         num Subjects

         208

      comment

      Safety Population included all participants who had received 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

         142

      2. group Id

         FG001

         num Subjects

         145

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         54

      2. group Id

         FG001

         num Subjects

         65

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants were enrolled from 19 Jan 2016 to 31 Oct 2018. A total of 406 participants were randomized in the study.

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Preserved source evidence · Not medical advice