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NCT02947685 · OUTCOME

Objective Response Rate (OR: CR or PR)

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer · Source last updated 2026-02-12

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
Not reported
Time frame
24 months

What was measured

Defined as proportion of patients that achieve complete response (CR) or partial response (PR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Analysis population: Patients evaluated for disease

Groups in this outcome

Arm A

Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)

Arm B

AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A231
Arm B230

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A0.329Not reportedNot reportedNot reportedNot reported
Arm B0.248Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.329
      2. group Id
        OG001
        value
        0.248
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      230
    units
    Participants
description
Defined as proportion of patients that achieve complete response (CR) or partial response (PR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    id
    OG000
    title
    Arm A
  2. description
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    id
    OG001
    title
    Arm B
param Type
NUMBER
population Description
Patients evaluated for disease
reporting Status
POSTED
time Frame
24 months
title
Objective Response Rate (OR: CR or PR)
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice