Participant flow

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer · Source last updated 2026-03-18

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

groups

1. description

   Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.

   id

   FG000

   title

   Vepdegestrant (ARV-471)

2. description

   Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.

   id

   FG001

   title

   Fulvestrant

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      type

      Randomized but not treated

   2. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         189

      2. group Id

         FG001

         num Subjects

         209

      type

      Progressive disease

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   7. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   8. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         9

      type

      Global deterioration of health status

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   10. reasons

       1. group Id

          FG000

          num Subjects

          96

       2. group Id

          FG001

          num Subjects

          76

       type

       Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         313

      2. group Id

         FG001

         num Subjects

         311

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         312

      2. group Id

         FG001

         num Subjects

         307

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         313

      2. group Id

         FG001

         num Subjects

         311

      type

      NOT COMPLETED

   title

   Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         35

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         161

      2. group Id

         FG001

         num Subjects

         186

      type

      Ongoing

   milestones

   1. achievements

      1. comment

         Participants who discontinued treatment could enter the follow-up.

         group Id

         FG000

         num Subjects

         205

      2. comment

         Participants who discontinued treatment could enter the follow-up.

         group Id

         FG001

         num Subjects

         224

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         205

      2. group Id

         FG001

         num Subjects

         224

      type

      NOT COMPLETED

   title

   Follow-up

pre Assignment Details

Results are reported at primary completion date (31 January 2025). Remaining results will be reported on completion of analysis at study completion date.

recruitment Details

Participants with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 negative (HER2-) unresectable locoregional recurrent or metastatic breast cancer (mBC) not amenable to radiotherapy with curative intent who progressed after prior endocrine based treatment(s) for advanced disease were included in this study.

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Preserved source evidence · Not medical advice