A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

Johns Hopkins Medicine

Status and phase

Terminated

Phase 2

Conditions

Stage II Breast Cancer

Stage I Breast Cancer

Stage III Breast Cancer

Invasive Breast Cancer

Treatments

Drug: Vorinostat and Tamoxifen

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01194427

NA_00033768 (Other Identifier)

J09144

Details and patient eligibility

About

This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 weeks.

Full description

Key eligibility criteria include:

Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
No prior or current use of any therapy to treat the current breast cancer.

Enrollment

2 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Stage I-III invasive breast cancer
Awaiting surgery or neoadjuvant treatment
ECOG performance status 0, 1 or 2
Adequate organ function
Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)

Exclusion criteria

Prior or current treatment of any kind for the current breast cancer
Current use of any other investigational drugs
Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness