Trial Outcomes & Findings for Protocol for Women at Increased Risk of Developing Breast Cancer (NCT NCT00291135)

Results Overview

Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2016-06-15

Participant milestones
Measure	Letrozole Letrozole, 2.5 mg daily for six months
Overall Study STARTED	42
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Protocol for Women at Increased Risk of Developing Breast Cancer

Baseline characteristics by cohort
Measure	Letrozole n=42 Participants Letrozole, 2.5 mg daily for six months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

Timeframe: Baseline, 6 months

Population: All subjects completed study and were used for analysis

Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.

Outcome measures
Measure	Letrozole n=42 Participants Letrozole, 2.5 mg daily for six months
Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.	-2.3 Change in % of cells positive for Ki-67 Interval -21.0 to 7.8

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Letrozole n=42 participants at risk Letrozole, 2.5 mg daily for six months
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 21/42 • Number of events 21 • 6 months
Reproductive system and breast disorders Hot Flash	61.9% 26/42 • Number of events 26 • 6 months
General disorders Fatigue	47.6% 20/42 • Number of events 20 • 6 months
Skin and subcutaneous tissue disorders alopecia	40.5% 17/42 • Number of events 17 • 6 months

University of Kansas Medical Center Research Institute

Phone: 913-588-7791