Participant flow

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) · Source last updated 2024-11-14

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

groups

1. description

   Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

   id

   FG000

   title

   Palbociclib Plus Letrozole

2. description

   Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

   id

   FG001

   title

   Placebo Plus Letrozole

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         286

      2. group Id

         FG001

         num Subjects

         172

      type

      Objective Progression or Relapse

   2. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         9

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         12

      type

      Global Deterioration of Health Status

   4. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         15

      type

      Participant Refused Continued Treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         8

      type

      Unspecified reasons

   6. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   7. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      Protocol Violation

   8. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Site Terminated by Sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         444

      2. group Id

         FG001

         num Subjects

         222

      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

         444

      2. group Id

         FG001

         num Subjects

         222

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The study consisted of a screening visit within 28 days before randomization, an active treatment phase, divided in cycles of 28 days each, and a post-treatment follow-up period during which survival and new anti-cancer therapy information was collected every 6 months (±7 days) from the last dose of study treatment.

recruitment Details

A total of 666 participants were randomized at 239 centers in 19 countries.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice