Trial Outcomes & Findings for Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer (NCT NCT01896050)

Results Overview

Change in BMI between baseline and 12 months of endocrine therapy

Recruitment status

COMPLETED

Target enrollment

115 participants

Primary outcome timeframe

baseline and 12 months

Results posted on

2016-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	AI Therapy Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen Subjects who started treatment with tamoxifen
Overall Study STARTED	93	22
Overall Study COMPLETED	55	20
Overall Study NOT COMPLETED	38	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AI Therapy Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen Subjects who started treatment with tamoxifen
Overall Study Adverse Event	37	2
Overall Study Death	1	0

Baseline Characteristics

Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AI Therapy n=93 Participants Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen n=22 Participants Subjects who started treatment with tamoxifen	Total n=115 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	61.5 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	22 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body-mass index	30.4 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants	29 kg/m^2 STANDARD_DEVIATION 7 • n=7 Participants	30.1 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants
Waist-hip ratio	0.91 ratio STANDARD_DEVIATION 0.09 • n=5 Participants	0.92 ratio STANDARD_DEVIATION 0.12 • n=7 Participants	0.91 ratio STANDARD_DEVIATION 0.09 • n=5 Participants
Maximum grip strength, right hand	57.5 kPa STANDARD_DEVIATION 11.7 • n=5 Participants	56.4 kPa STANDARD_DEVIATION 10.9 • n=7 Participants	57.3 kPa STANDARD_DEVIATION 11.5 • n=5 Participants
Maximum grip strength, left hand	54.8 kPa STANDARD_DEVIATION 10.9 • n=5 Participants	53.7 kPa STANDARD_DEVIATION 10.7 • n=7 Participants	54.6 kPa STANDARD_DEVIATION 10.8 • n=5 Participants
Average pain	2.3 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	2.4 units on a scale STANDARD_DEVIATION 1.9 • n=7 Participants	2.3 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 months

Population: These data only include patients who completed a full 12 months of treatment with either an aromatase inhibitor or tamoxifen and had grip strength data at both baseline and 12 months. Patients could have switched from one aromatase inhibitor to another. Those patients who discontinued treatment prior to the 12 month period were excluded.

Change in BMI between baseline and 12 months of endocrine therapy

Outcome measures

Outcome measures
Measure	AI Therapy n=71 Participants Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen n=18 Participants Subjects who started treatment with tamoxifen
Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy	-0.15 kg/m^2 Standard Deviation 5.70	2.44 kg/m^2 Standard Deviation 6.11

SECONDARY outcome

Timeframe: baseline and 12 months

Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months

Outcome measures

Outcome measures
Measure	AI Therapy n=93 Participants Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen n=22 Participants Subjects who started treatment with tamoxifen
Effect of Medication on Change in Grip Strength	-7.0 percent change Standard Deviation 15.9	0.6 percent change Standard Deviation 10.2

SECONDARY outcome

Timeframe: baseline and 12 months

Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment

Outcome measures

Outcome measures
Measure	AI Therapy n=93 Participants Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen n=22 Participants Subjects who started treatment with tamoxifen
Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months	37 participants	2 participants

Adverse Events

AI Therapy

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Tamoxifen

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AI Therapy n=93 participants at risk Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen n=22 participants at risk Subjects who started treatment with tamoxifen
General disorders death	1.1% 1/93 • Number of events 1 • 12 months only unexpected serious adverse events were collected	0.00% 0/22 • 12 months only unexpected serious adverse events were collected

Other adverse events

Other adverse events
Measure	AI Therapy n=93 participants at risk Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Tamoxifen n=22 participants at risk Subjects who started treatment with tamoxifen
General disorders symptom leading to treatment discontinuation	39.8% 37/93 • Number of events 37 • 12 months only unexpected serious adverse events were collected	9.1% 2/22 • Number of events 2 • 12 months only unexpected serious adverse events were collected

Additional Information

Norah Lynn Henry, MD

University of Michigan Comprehensive Cancer Center

Phone: 734-936-4991

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place