Invasive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Conditions
Keywords
Preoperative, Neoadjuvant
Brief summary
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.
Detailed 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.
Interventions
DRUGVorinostat and Tamoxifen
vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
Sponsors
Merck Sharp & Dohme LLC
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Markers of Proliferation Prior to and After Study Drug Administration | Baseline and 14 days | 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. |
Countries
United States
Participant flow
Recruitment details
Patients will be recruited through the breast cancer clinics at each of the participating centers (ie, Johns Hopkins).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Vorinostat and Tamoxifen Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Vorinostat and Tamoxifen |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Changes in Markers of Proliferation Prior to and After Study Drug Administration
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.
Time frame: 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.