Know Cancer

or
forgot password

A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Invasive Breast Cancer

Thank you

Trial Information

A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Changes in Markers of Proliferation Prior to and After Study Drug Administration

Outcome Description:

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.

Outcome Time Frame:

Baseline and 14 days

Safety Issue:

No

Principal Investigator

Vered Stearns, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

J09144

NCT ID:

NCT01194427

Start Date:

March 2011

Completion Date:

November 2011

Related Keywords:

  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Invasive Breast Cancer
  • Preoperative
  • Neoadjuvant
  • Breast Neoplasms

Name

Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410