Trial Outcomes & Findings for Biology Guided Therapy for Breast Cancer for ER Positive (NCT NCT04965688)

NCT ID: NCT04965688

Last Updated: 2025-04-10

Results Overview

No data displayed because Outcome Measure has zero total participants analyzed.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Baseline to 36 Months

Results posted on

2025-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Aromatase Inhibitor and CDK Inhibition Drug determined by treating oncologist based on recommendation from systems biology analysis.: All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Aromatase Inhibitor and CDK Inhibition Drug determined by treating oncologist based on recommendation from systems biology analysis.: All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Biology Guided Therapy for Breast Cancer for ER Positive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aromatase Inhibitor and CDK Inhibition n=2 Participants Drug determined by treating oncologist based on recommendation from systems biology analysis.: All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 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	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	2 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
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 36 Months

Population: Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination.

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 36 Months

Population: Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination.

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 36 Months

Population: Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination.

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 36 Months

Population: Two patients enrolled on the study and then withdrew early prior to treatment, therefore no data were collected before study termination.

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Aromatase Inhibitor and CDK Inhibition

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

Adam Cohen, MD

Inova Health System

Phone: 7035767279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place