Clinical trial · Interventional
A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty meeting patient accrual goals
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vorinostat and Tamoxifen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat and Tamoxifen
- description
- Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
- interventionNames
- Drug: Vorinostat and Tamoxifen
Primary outcomes (1)
- measure
- Changes in Markers of Proliferation Prior to and After Study Drug Administration
- timeFrame
- Baseline and 14 days
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available