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NCT05654623 · OUTCOME

Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From baseline up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)

What was measured

Twelve lead ECGs were collected using an automated ECG machine that calculated heart rate and measured corrected QT (QTc interval, QT interval, PR interval and QRS complex). Criteria for heart rate was as follows, \<= 50 beats/minute (min), \>=100 beats/min, increase from baseline \>= 20 beats/min, decrease from baseline \>= 20 beats/min. Criteria for PR interval was \>= 220 millisecond (msec). Criteria for QRS interval was \>= 120 msec. Criteria for QT interval was as follows, \<=450 msec, \> 450 to \<= 480 msec, \>480 to \<=500 msec, \>500 msec, increase from baseline \<= 30 msec, increase from baseline \> 30 to \<= 60 msec. Criteria for QTCF interval was as follows, \<=450 msec, \> 450 to \<= 480 msec, \> 480 to \<= 500 msec, \> 500 msec, increase from baseline \<= 30 msec, increase from baseline \> 30 to \<= 60 msec, increase from baseline \> 60 msec. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment.

Analysis population: SAS included all randomized participants who received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for this outcome measure

Groups in this outcome

Vepdegestrant (ARV-471)

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.

Fulvestrant

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.

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
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Reported measurements

Heart rate <= 50 beats/min

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	4	Not reported	Not reported	Not reported	Not reported
Fulvestrant	1	Not reported	Not reported	Not reported	Not reported

Heart rate >= 100 beats/min

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	23	Not reported	Not reported	Not reported	Not reported
Fulvestrant	19	Not reported	Not reported	Not reported	Not reported

Heart rate increase from baseline >=20 beats/min

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	307
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	17	Not reported	Not reported	Not reported	Not reported
Fulvestrant	15	Not reported	Not reported	Not reported	Not reported

Heart rate decrease from baseline >=20 beats/min

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	307
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	22	Not reported	Not reported	Not reported	Not reported
Fulvestrant	10	Not reported	Not reported	Not reported	Not reported

PR interval >= 220 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	305
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	4	Not reported	Not reported	Not reported	Not reported
Fulvestrant	4	Not reported	Not reported	Not reported	Not reported

QRS interval >=120 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	6	Not reported	Not reported	Not reported	Not reported
Fulvestrant	10	Not reported	Not reported	Not reported	Not reported

QT interval <=450 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	232	Not reported	Not reported	Not reported	Not reported
Fulvestrant	278	Not reported	Not reported	Not reported	Not reported

QT interval >450 to <=480 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	53	Not reported	Not reported	Not reported	Not reported
Fulvestrant	19	Not reported	Not reported	Not reported	Not reported

QT interval >480 to <=500 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	16	Not reported	Not reported	Not reported	Not reported
Fulvestrant	4	Not reported	Not reported	Not reported	Not reported

QT interval > 500 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	8	Not reported	Not reported	Not reported	Not reported
Fulvestrant	0	Not reported	Not reported	Not reported	Not reported

QT intervals increase from baseline <= 30 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	308
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	171	Not reported	Not reported	Not reported	Not reported
Fulvestrant	267	Not reported	Not reported	Not reported	Not reported

QT intervals increase from baseline > 30 to <=60 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	308
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	111	Not reported	Not reported	Not reported	Not reported
Fulvestrant	28	Not reported	Not reported	Not reported	Not reported

QT intervals increase from baseline > 60 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	308
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	26	Not reported	Not reported	Not reported	Not reported
Fulvestrant	6	Not reported	Not reported	Not reported	Not reported

QTcF interval <=450 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	308
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	177	Not reported	Not reported	Not reported	Not reported
Fulvestrant	260	Not reported	Not reported	Not reported	Not reported

QTcF interval >450 to <=480 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	116	Not reported	Not reported	Not reported	Not reported
Fulvestrant	38	Not reported	Not reported	Not reported	Not reported

QTcF interval >480 to <=500 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	11	Not reported	Not reported	Not reported	Not reported
Fulvestrant	1	Not reported	Not reported	Not reported	Not reported

QTcF interval > 500 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	309
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	5	Not reported	Not reported	Not reported	Not reported
Fulvestrant	2	Not reported	Not reported	Not reported	Not reported

QTcF interval increase from baseline <= 30 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	307
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	228	Not reported	Not reported	Not reported	Not reported
Fulvestrant	291	Not reported	Not reported	Not reported	Not reported

QTcF interval increase from baseline > 30 to <= 60 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	307
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	71	Not reported	Not reported	Not reported	Not reported
Fulvestrant	9	Not reported	Not reported	Not reported	Not reported

QTcF interval increase from baseline > 60 msec

Analysis denominator · Participants

Group	Source count
Vepdegestrant (ARV-471)	307
Fulvestrant	301

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Vepdegestrant (ARV-471)	8	Not reported	Not reported	Not reported	Not reported
Fulvestrant	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants
title
Heart rate <= 50 beats/min
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
19
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants
title
Heart rate >= 100 beats/min
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
15
denoms
counts
group Id
OG000
value
307
group Id
OG001
value
301
units
Participants
title
Heart rate increase from baseline >=20 beats/min
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
10
denoms
counts
group Id
OG000
value
307
group Id
OG001
value
301
units
Participants
title
Heart rate decrease from baseline >=20 beats/min
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
305
group Id
OG001
value
301
units
Participants
title
PR interval >= 220 msec
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
10
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants
title
QRS interval >=120 msec
categories
measurements
group Id
OG000
value
232
group Id
OG001
value
278
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants
title
QT interval <=450 msec
categories
measurements
group Id
OG000
value
53
group Id
OG001
value
19
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants
title
QT interval >450 to <=480 msec
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants
title
QT interval >480 to <=500 msec
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants
title
QT interval > 500 msec
categories
measurements
group Id
OG000
value
171
group Id
OG001
value
267
denoms
counts
group Id
OG000
value
308
group Id
OG001
value
301
units
Participants
title
QT intervals increase from baseline <= 30 msec
categories
measurements
group Id
OG000
value
111
group Id
OG001
value
28
denoms
counts
group Id
OG000
value
308
group Id
OG001
value
301
units
Participants
title
QT intervals increase from baseline > 30 to <=60 msec

denoms

counts
group Id
OG000
value
309
group Id
OG001
value
301
units
Participants

description

Twelve lead ECGs were collected using an automated ECG machine that calculated heart rate and measured corrected QT (QTc interval, QT interval, PR interval and QRS complex). Criteria for heart rate was as follows, \<= 50 beats/minute (min), \>=100 beats/min, increase from baseline \>= 20 beats/min, decrease from baseline \>= 20 beats/min. Criteria for PR interval was \>= 220 millisecond (msec). Criteria for QRS interval was \>= 120 msec. Criteria for QT interval was as follows, \<=450 msec, \> 450 to \<= 480 msec, \>480 to \<=500 msec, \>500 msec, increase from baseline \<= 30 msec, increase from baseline \> 30 to \<= 60 msec. Criteria for QTCF interval was as follows, \<=450 msec, \> 450 to \<= 480 msec, \> 480 to \<= 500 msec, \> 500 msec, increase from baseline \<= 30 msec, increase from baseline \> 30 to \<= 60 msec, increase from baseline \> 60 msec. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment.

groups

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
OG000
title
Vepdegestrant (ARV-471)
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
OG001
title
Fulvestrant

param Type

COUNT_OF_PARTICIPANTS

population Description

SAS included all randomized participants who received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for this outcome measure

reporting Status

POSTED

time Frame

From baseline up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)

title

Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice