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Trial Outcomes & Findings for Re-expression of ER in Triple Negative Breast Cancers (NCT NCT01194908)

NCT ID: NCT01194908

Last Updated: 2015-01-26

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.

Results posted on

2015-01-26

Participant Flow

Participant milestones

Participant milestones
Measure
Arm A
Patients treated with decitabine and LBH589 Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2 Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2 Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2 Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2 Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2 Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Overall Study
STARTED
5
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Re-expression of ER in Triple Negative Breast Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A
n=5 Participants
Patients treated with decitabine and LBH589 Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2 Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2 Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2 Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2 Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2 Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2
Age, Customized
30-39 years
1 participants
n=5 Participants
Age, Customized
40-49 years
2 participants
n=5 Participants
Age, Customized
50-59 years
2 participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants

PRIMARY outcome

Timeframe: Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.

Population: No data were analyzed due to trial termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Patients will undergo an evaluation for extent of disease 8 weeks from starting study drugs and every 8 weeks (2 cycles) while on study.

Population: No data were analyzed due to trial termination.

Outcome measures

Outcome data not reported

Adverse Events

Arm A

Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm A
n=5 participants at risk
Patients treated with decitabine and LBH589 Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2 Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2 Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2 Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2 Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2 Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2
General disorders
Death
80.0%
4/5

Other adverse events

Adverse event data not reported

Additional Information

Ruth O'Regan, MD

Emory University School of Medicine

Phone: 404-778-4824

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place