NCT03901339 · OUTCOME

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift From Baseline Value to Best Value During Treatment

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer · Source last updated 2024-10-21

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Up to 43.4 months

What was measured

ECOG performance status (PS) measured on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease performance without restriction;1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature;2=Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;3=Capable of only limited self-care;confined to bed or chair more than 50% of waking hours;4=Completely disabled; cannot carry on any self-care; totally confined to bed or chair;5=Dead. Lower score indicated good performance status. Percentage of participants with Baseline ECOG PS score and corresponding changes to the best values post-baseline have been reported.

Analysis population: Participants in the Safety Population were analyzed.

Groups in this outcome

Sacituzumab Govitecan

Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).

Treatment of Physician's Choice (TPC)

Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.

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

Analysis denominator · Participants

Group	Source count
Sacituzumab Govitecan	268
Treatment of Physician's Choice (TPC)	249

Reported measurements

Baseline ECOG 0, During Treatment ECOG 0

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sacituzumab Govitecan	34.9	Not reported	Not reported	Not reported	Not reported
Treatment of Physician's Choice (TPC)	38.7	Not reported	Not reported	Not reported	Not reported

Baseline ECOG 0, During Treatment ECOG 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sacituzumab Govitecan	7.8	Not reported	Not reported	Not reported	Not reported
Treatment of Physician's Choice (TPC)	8.9	Not reported	Not reported	Not reported	Not reported

Baseline ECOG 0, During Treatment ECOG 2

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sacituzumab Govitecan	0	Not reported	Not reported	Not reported	Not reported
Treatment of Physician's Choice (TPC)	0.4	Not reported	Not reported	Not reported	Not reported

Baseline ECOG 1, During Treatment ECOG 0

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sacituzumab Govitecan	19.4	Not reported	Not reported	Not reported	Not reported
Treatment of Physician's Choice (TPC)	11.5	Not reported	Not reported	Not reported	Not reported

Baseline ECOG 1, During Treatment ECOG 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sacituzumab Govitecan	36.4	Not reported	Not reported	Not reported	Not reported
Treatment of Physician's Choice (TPC)	38.3	Not reported	Not reported	Not reported	Not reported

Baseline ECOG 1, During Treatment ECOG 2

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sacituzumab Govitecan	1.6	Not reported	Not reported	Not reported	Not reported
Treatment of Physician's Choice (TPC)	2.1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
34.9
group Id
OG001
value
38.7
title
Baseline ECOG 0, During Treatment ECOG 0
categories
measurements
group Id
OG000
value
7.8
group Id
OG001
value
8.9
title
Baseline ECOG 0, During Treatment ECOG 1
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0.4
title
Baseline ECOG 0, During Treatment ECOG 2
categories
measurements
group Id
OG000
value
19.4
group Id
OG001
value
11.5
title
Baseline ECOG 1, During Treatment ECOG 0
categories
measurements
group Id
OG000
value
36.4
group Id
OG001
value
38.3
title
Baseline ECOG 1, During Treatment ECOG 1
categories
measurements
group Id
OG000
value
1.6
group Id
OG001
value
2.1
title
Baseline ECOG 1, During Treatment ECOG 2

denoms

counts
group Id
OG000
value
268
group Id
OG001
value
249
units
Participants

description

groups

description
Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
id
OG000
title
Sacituzumab Govitecan
description
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
id
OG001
title
Treatment of Physician's Choice (TPC)

param Type

NUMBER

population Description

Participants in the Safety Population were analyzed.

reporting Status

POSTED

time Frame

Up to 43.4 months

title

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Shift From Baseline Value to Best Value During Treatment

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice