Trial Outcomes & Findings for Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women (NCT NCT00256217)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Baseline and up to 4 weeks

Results posted on

2021-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Anastrozole Anastrozole: 1 mg. oral every day for 2 - 4 weeks
Overall Study STARTED	42
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anastrozole n=34 Participants Anastrozole: 1 mg. oral every day for 2 - 4 weeks
Age, Customized	63.2 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to 4 weeks

Population: 23 patients had both baseline data and off-treatment data available

Outcome measures

Outcome measures
Measure	Anastrozole n=23 Participants Anastrozole: 1 mg. oral every day for 2 - 4 weeks
Number of Participants With a Change in Ki-67 Level Decreased Ki-67 level	15 Participants
Number of Participants With a Change in Ki-67 Level No Change in Ki-67	5 Participants
Number of Participants With a Change in Ki-67 Level Increased Ki-67 level	3 Participants

SECONDARY outcome

Timeframe: Baseline and up to 4 weeks

Population: 24 patients had baseline data and post-treatment available.

Assessed by changes in Nottingham grade

Outcome measures

Outcome measures
Measure	Anastrozole n=24 Participants Anastrozole: 1 mg. oral every day for 2 - 4 weeks
Histopathological Response Decreased	7 Participants
Histopathological Response No Change	17 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks after anastrozole

Outcome measures

Outcome measures
Measure	Anastrozole n=17 Participants Anastrozole: 1 mg. oral every day for 2 - 4 weeks
To Compare Pretreatment Vascular Density With Post Treatment Vascular Density Using MRI Decreased	7 Participants
To Compare Pretreatment Vascular Density With Post Treatment Vascular Density Using MRI No Change	9 Participants
To Compare Pretreatment Vascular Density With Post Treatment Vascular Density Using MRI Increased	1 Participants

SECONDARY outcome

Timeframe: Baseline and up to 4 weeks

Population: Data was not collected and analysis of this outcome measure was not done.

Outcome measures

Outcome data not reported

Adverse Events

Anastrozole

Serious events: 0 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anastrozole n=42 participants at risk Anastrozole: 1 mg. oral every day for 2 - 4 weeks
General disorders Sores in mouth and between fingers	2.4% 1/42 • First receipt of first of study drug until 30 days have elapsed following cessation of study drug, a total of up to 8 weeks. There were no reported serious adverse events for this trial.

Additional Information

UC Irvine Health / Chao Family Comprehensive Cancer Center

Phone: 1-877-UC-STUDY

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place