Clinical trial · Interventional
Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer
A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer
NCT00262834CI-TRIAL-00043504completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Other | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgery of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.
- interventionNames
- Drug: vorinostat
- Other: conventional surgery
Primary outcomes (3)
- measure
- Number of Participants With Adverse Events
- timeFrame
- After 3 days of vorinostat
- description
- Participants were evaluated for adverse events due to vorinostat to assess if it was safe to give the drug prior to surgery. 17 of 25 participants who received vorinostat experienced at least 1 adverse event believed to be related to the study drug; no adverse events were severe, and the treatment was considered safe.
- measure
- Change in Tissue Proliferation After 3 Days of Treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * No prior or concurrent hormonal therapy for breast cancer * Histologically confirmed breast cancer, stage I-III disease, scheduled to undergo definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic treatment) for breast cancer * ECOG 0-2 OR Karnofsky 60-100% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal * PT ≤ 14 seconds * Creatinine normal * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled intercurrent illness * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat * At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin) * Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed * No concurrent birth control pills * No prior radiotherapy to the ipsilateral breast * No prior or concurrent radiotherapy for breast cancer * No prior or concurrent novel therapy for breast cancer * At least 14 days since prior valproic acid or another histone deacetylase inhibitor * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent therapy for this cancer * WBC ≥ 3,000/mm\^3 Exclusion criteria: * Patients must not be recieving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA. * Patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating SAHA. * Women who are pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.