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A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast


- To evaluate the in vivo molecular and biological effects of vorinostat by analyzing
changes in proliferation and apoptosis, histone acetylation, and HDAC protein
expression in women with ductal carcinoma in situ of the breast.

OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of
unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last
dose of vorinostat.

Blood and tissue samples are collected at baseline and during surgery for biomarker
laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6
protein expression, and histone H4 and α-tubulin acetylation.

After completion of study therapy, patients are followed for 1 month and then every 6 months
for 5 years.

Inclusion Criteria


- Histologically confirmed (by core biopsy) ductal carcinoma in situ

- Stage 0 disease

- Hormone receptor status not specified


- Menopausal status not specified

- ECOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Potassium and magnesium levels normal

- Prothrombin time or INR ≤ 1.5 times upper limit of normal (ULN) (unless the patient
is receiving therapeutic anticoagulation)

- Partial thromboplastin time ≤ 1.2 times ULN (unless the patient is receiving
therapeutic anticoagulation)

- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective barrier methods of contraception

- No known psychiatric or substance abuse disorder that would preclude cooperation with
the study requirements

- No active hepatitis A, B, or C infection

- No active HIV infection

- No other active infection

- No other malignancy within the past 5 years

- No condition that would interfere with the absorption or intake of vorinostat

- No history or current evidence of any condition or laboratory abnormality that would
confound study results, interfere with the patient's participation in the full
duration of the study, or that would not be in the best interest of the patient to


- More than 2 weeks since prior IV antibiotics, antivirals, or antifungals

- No prior gastrointestinal surgery or other procedure that would interfere with the
absorption or intake of vorinostat

- No prior or concurrent therapy with any other HDAC inhibitor, including valproic acid

- No prior treatment with any other investigational agent

- No concurrent systemic steroids

- No concurrent anticancer chemotherapy, radiotherapy, biological therapy, or other
investigational therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction in Ki-67 compared to baseline Ki-67

Outcome Time Frame:

3 days prior to surgery

Safety Issue:


Principal Investigator

Laura Esserman, MD, MBA

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115