Trial Outcomes & Findings for Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance (NCT NCT04864405)

Results Overview

Measured by the change in total Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire from baseline to 12 weeks following the beginning of endocrine therapy. FACT-ES is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much), with a total range of 0 to 184. Higher FACT-ES scores indicate better outcomes. The current outcome is a change in FACT-ES scores.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

245 participants

Primary outcome timeframe

Baseline to 12 weeks after treatment initiation

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Morning Administration of Endocrine Therapy Administration of endocrine therapy defined as, within one hour of the patient wake up time Morning administration of endocrine therapy: Endocrine therapy administered within one hour of patient wake up time	Evening Administration of Endocrine Therapy Administration of endocrine therapy defined as, within one hour of the patient bed time Evening administration of endocrine therapy: Endocrine therapy administered within one hour of the patient bed time
Overall Study STARTED	122	123
Overall Study COMPLETED	115	112
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Morning Administration of Endocrine Therapy Administration of endocrine therapy defined as, within one hour of the patient wake up time Morning administration of endocrine therapy: Endocrine therapy administered within one hour of patient wake up time	Evening Administration of Endocrine Therapy Administration of endocrine therapy defined as, within one hour of the patient bed time Evening administration of endocrine therapy: Endocrine therapy administered within one hour of the patient bed time
Overall Study Withdrawal by Subject	4	6
Overall Study Did not want endocrine therapy	3	5

Baseline Characteristics

Sex (male/female) was not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morning Administration of Endocrine Therapy n=122 Participants Administration of endocrine therapy defined as, within one hour of the patient wake up time Morning administration of endocrine therapy: Endocrine therapy administered within one hour of patient wake up time	Evening Administration of Endocrine Therapy n=123 Participants Administration of endocrine therapy defined as, within one hour of the patient bed time Evening administration of endocrine therapy: Endocrine therapy administered within one hour of the patient bed time	Total n=245 Participants Total of all reporting groups
Age, Continuous	61.1 years STANDARD_DEVIATION 12.5 • n=122 Participants	61.0 years STANDARD_DEVIATION 11.2 • n=123 Participants	61.1 years STANDARD_DEVIATION 11.9 • n=245 Participants
Sex: Female, Male Female	—	—	0 Participants Sex (male/female) was not collected.
Sex: Female, Male Male	—	—	0 Participants Sex (male/female) was not collected.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	122 participants n=122 Participants	123 participants n=123 Participants	245 participants n=245 Participants
Type of endocrine therapy Tamoxifen	93 Participants n=122 Participants	94 Participants n=123 Participants	187 Participants n=245 Participants
Type of endocrine therapy Anastrozole	20 Participants n=122 Participants	22 Participants n=123 Participants	42 Participants n=245 Participants
Type of endocrine therapy Letrozole	9 Participants n=122 Participants	7 Participants n=123 Participants	16 Participants n=245 Participants
Type of endocrine therapy Exemestane	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Type of endocrine therapy LHRH	10 Participants n=122 Participants	12 Participants n=123 Participants	22 Participants n=245 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks after treatment initiation

Population: The participants who answered the FACT-ES at baseline and 12 weeks.

Measured by the change in total Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire from baseline to 12 weeks following the beginning of endocrine therapy. FACT-ES is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much), with a total range of 0 to 184. Higher FACT-ES scores indicate better outcomes. The current outcome is a change in FACT-ES scores.

Outcome measures

Outcome measures
Measure	Morning Administration of Endocrine Therapy n=103 Participants Administration of endocrine therapy defined as, within one hour of the patient wake up time Morning administration of endocrine therapy: Endocrine therapy administered within one hour of patient wake up time	Evening Administration of Endocrine Therapy n=102 Participants Administration of endocrine therapy defined as, within one hour of the patient bed time Evening administration of endocrine therapy: Endocrine therapy administered within one hour of the patient bed time
Change in Endocrine Toxicity and Tolerability at 12 Weeks	-2.2 units on a scale Standard Deviation 14.1	-5.0 units on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: Baseline, 4, 8, 12 and 52 weeks after treatment initiation

Population: The number analyzed differs from overall number analyzed because not all participants completed the questionnaires at all timepoints.

Measured by the change in total score and individual Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaires from baseline to 4, 8, 12 and 52 weeks following the beginning of endocrine therapy. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much), with a total score range of 0 to 184. Higher scores indicate better quality of life. The current outcome is a change in FACT-ES scores over time.

Outcome measures

Outcome measures
Measure	Morning Administration of Endocrine Therapy n=122 Participants Administration of endocrine therapy defined as, within one hour of the patient wake up time Morning administration of endocrine therapy: Endocrine therapy administered within one hour of patient wake up time	Evening Administration of Endocrine Therapy n=123 Participants Administration of endocrine therapy defined as, within one hour of the patient bed time Evening administration of endocrine therapy: Endocrine therapy administered within one hour of the patient bed time
Change in Endocrine Toxicity and Tolerability Baseline to 4 Weeks	-0.3 units on a scale Standard Deviation 12.6	-0.5 units on a scale Standard Deviation 14.6
Change in Endocrine Toxicity and Tolerability Baseline to 8 Weeks	-1.6 units on a scale Standard Deviation 13.7	-2.3 units on a scale Standard Deviation 13.6
Change in Endocrine Toxicity and Tolerability Baseline to 12 Weeks	-2.2 units on a scale Standard Deviation 14.1	-5.0 units on a scale Standard Deviation 16.8
Change in Endocrine Toxicity and Tolerability Baseline to 52 Weeks	-3.0 units on a scale Standard Deviation 18.7	-4.7 units on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline, 4, 8, 12 and 52 weeks after treatment initiation

Population: The number analyzed differs from the overall number of participants analyzed because not all participants completed all questionnaires at all timepoints.

Measured by the change in the total score and individual sub scales of the validated Functional Assessment of Cancer Therapy for patients with Breast cancer (FACT-B) questionnaire from baseline to 4, 8, 12 and 52 weeks following the beginning of endocrine therapy. The FACT-B consists of 37 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much), with a total score range of 0 to 148. Higher FACT-B scores indicate better quality of life. The current outcome is a change in FACT-B scores over time.

Outcome measures

Outcome measures
Measure	Morning Administration of Endocrine Therapy n=122 Participants Administration of endocrine therapy defined as, within one hour of the patient wake up time Morning administration of endocrine therapy: Endocrine therapy administered within one hour of patient wake up time	Evening Administration of Endocrine Therapy n=123 Participants Administration of endocrine therapy defined as, within one hour of the patient bed time Evening administration of endocrine therapy: Endocrine therapy administered within one hour of the patient bed time
Change in Health Related Quality of Life Scores Baseline to 4 Weeks	1.9 units on a scale Standard Deviation 12.0	1.2 units on a scale Standard Deviation 11.6
Change in Health Related Quality of Life Scores Baseline to 8 Weeks	1.4 units on a scale Standard Deviation 12.3	0.9 units on a scale Standard Deviation 10.7
Change in Health Related Quality of Life Scores Baseline to 12 Weeks	2.3 units on a scale Standard Deviation 13.6	-0.6 units on a scale Standard Deviation 14.1
Change in Health Related Quality of Life Scores Baseline to 52 weeks	1.9 units on a scale Standard Deviation 18.0	0.8 units on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: 52 weeks after treatment initiation

Population: This is the modified intention-to-treat population.

Rates of non-persistence or non-compliance with initially prescribed endocrine therapy (ET)

Outcome measures

Outcome measures
Measure	Morning Administration of Endocrine Therapy n=111 Participants Administration of endocrine therapy defined as, within one hour of the patient wake up time Morning administration of endocrine therapy: Endocrine therapy administered within one hour of patient wake up time	Evening Administration of Endocrine Therapy n=110 Participants Administration of endocrine therapy defined as, within one hour of the patient bed time Evening administration of endocrine therapy: Endocrine therapy administered within one hour of the patient bed time
Number of Participants Who Were Compliant With ET Still taking ET	103 Participants	100 Participants
Number of Participants Who Were Compliant With ET Still taking ET at the assigned time	105 Participants	105 Participants
Number of Participants Who Were Compliant With ET No interruptions of ET greater than 7 days	103 Participants	95 Participants
Number of Participants Who Were Compliant With ET Still taking ET with no interruptions greater than 7 days and no change in ET type	88 Participants	84 Participants

SECONDARY outcome

Timeframe: 52 weeks after treatment initiation

Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 weeks after treatment initiation

Population: This was an exploratory analysis and it was not performed.

Comparing rates of non-compliance and non-persistence to endocrine therapy with patient age, turmour stage, chemotherapy use and type of endocrine therapy. The rates of non-compliance and rates of non-persistence will be tracked throughout the duration of the study and then compared to patient age, tumour stage, chemotherapy use and the type of endocrine therapy used.

Outcome measures

Outcome data not reported

Adverse Events

Morning Administration of Endocrine Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Evening Administration of Endocrine Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie-France Savard, MD

The Ottawa Hospital Cancer Centre

Phone: 613-737-7700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place