Trial Outcomes & Findings for A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer (NCT NCT01194427)

NCT ID: NCT01194427

Last Updated: 2013-05-17

Results Overview

To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Baseline and 14 days

Results posted on

2013-05-17

Participant Flow

Patients will be recruited through the breast cancer clinics at each of the participating centers (ie, Johns Hopkins).

Women 18 years or older with a histologically confirmed diagnosis of invasive mammary carcinoma on a core needle biopsy and with adequate organ function who are awaiting a definitive surgical procedure or initiation of neoadjuvant chemotherapy are eligible.

Participant milestones

Participant milestones
Measure	Vorinostat and Tamoxifen Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorinostat and Tamoxifen n=2 Participants Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 14 days

Population: Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report.

Outcome measures

Outcome data not reported

Adverse Events

Vorinostat and Tamoxifen

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vorinostat and Tamoxifen n=2 participants at risk Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
Gastrointestinal disorders Anorexia	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Gastrointestinal disorders Diarrhea	100.0% 2/2 • Number of events 2 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Nervous system disorders Dizziness	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Gastrointestinal disorders Dysgeusia	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
General disorders Fatigue	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Gastrointestinal disorders Flatulence	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Vascular disorders Hot flashes	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Skin and subcutaneous tissue disorders Rash acneiform	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.
Renal and urinary disorders Urinary frequency	50.0% 1/2 • Number of events 1 • 14 days Adverse events were assessed at baseline, after 14 days of study drug administration, and after the surgical procedure per CTCAE V. 4.0.

Additional Information

Dr. Vered Stearns

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 4432876489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place