Trial Outcomes & Findings for Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer (NCT NCT01313039)

Results Overview

To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

4 participants

Primary outcome timeframe

2 years

Results posted on

2017-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Overall Study Physician Decision	1
Overall Study Adverse Event	1

Baseline Characteristics

Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD6244 n=4 Participants AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Age, Continuous	59.75 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Gender Female	4 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Only 1 subject had evaluable study data

To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.

Outcome measures

Outcome measures
Measure	Single Arm n=1 Participants AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Increase of ER Protein Expression in ER-Negative/Low Breast Cancer	1 participants

SECONDARY outcome

Timeframe: 2 Years

To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

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

Judith Hurley MD

University of Miami Sylvester Comprehensive Cancer Center

Phone: 305-243-6462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place