Participant flow

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355) · Source last updated 2024-11-27

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

groups

1. description

   Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.

   id

   FG000

   title

   Part 1: Pembrolizumab + Nab-Paclitaxel

2. description

   Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.

   id

   FG001

   title

   Part 1: Pembrolizumab + Paclitaxel

3. description

   Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.

   id

   FG002

   title

   Part 1: Pembrolizumab + Gemcitabine/Carboplatin

4. description

   Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).

   id

   FG003

   title

   Part 2: Pembrolizumab + Chemotherapy

5. description

   Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle

   id

   FG004

   title

   Part 2: Placebo + Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         475

      5. group Id

         FG004

         num Subjects

         244

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         25

      5. group Id

         FG004

         num Subjects

         8

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         34

      5. group Id

         FG004

         num Subjects

         17

      type

      Sponsor Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         32

      5. group Id

         FG004

         num Subjects

         11

      type

      Transferred to extension study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         566

      5. group Id

         FG004

         num Subjects

         281

      type

      STARTED

   2. achievements

      1. comment

         One participant randomized did not receive treatment. 3 participants randomized to Pembrolizumab + Paclitaxel group received Pembrolizumab + Nab-Paclitaxel treatment in error

         group Id

         FG000

         num Subjects

         13

      2. comment

         3 participants randomized to Pembrolizumab + Paclitaxel received pembrolizumab + Nab-Paclitaxel in error; 1 participant received pembrolizumab Gemcitabine/Carboplatin in error

         group Id

         FG001

         num Subjects

         10

      3. comment

         1 participant randomized to Pembrolizumab + Paclitaxel group received Pembrolizumab + Gemcitabine/Carboplatin in error

         group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         562

      5. group Id

         FG004

         num Subjects

         281

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         566

      5. group Id

         FG004

         num Subjects

         281

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

35 participants were randomized to Part 1 (Safety Run-in) of the study, and 847 participants were randomized in Part 2 (phase 3) of the study. 12 participants randomized to the Part 2: Pembrolizumab + Chemotherapy arm received a second course of pembrolizumab at the investigator's discretion. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures respectively.

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Preserved source evidence · Not medical advice