A Phase 2 interventional study of vorinostat and conventional surgery in Breast Cancer, Stage I Breast Cancer and Stage II Breast Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer.
OULINE: This is a multicenter, pilot study.
Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0.
After completion of study treatment, patients are followed for 30 days.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 54 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Drug: vorinostat · Other: conventional surgery
Given orally, conventional surgery to follow.
Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Undergo conventional surgery
Also known as: surgery, conventional
Number of Participants With Adverse Events
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.
Time frame: After 3 days of vorinostat
Change in Tissue Proliferation After 3 Days of Treatment
Change in Ki-67 (a marker of tissue proliferation) by IHC compared to baseline in the treated (22 evaluable samples) or untreated patients (15 evaluable samples) were analyzed between groups. Ki-67 is a protein in cells that increases as cellsprepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells.
Time frame: After 3 days of vorinostat
Change in Tissue Apoptosis After 3 Days of Treatment
Change in cleaved caspase-3 (a marker of tissue apoptosis) by IHC compared to baseline in the treated (19 evaluable samples) or untreated patients (12 evaluable samples) were analyzed between groups. Cleaved caspase-3 is a protein in cells involved in apoptosis (cell death).
Time frame: Baseline and after 3 day of vorinostat
Change in Tissue Histone Acetylation After 3 Days of Treatment
To evaluate change from baseline in tissue histone acetylation in patients with primary breast cancer who received three days of Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment. This is measured by Cumulative Methylation Index, which is reported as the sum of all %M for all genes. %M= (methylated copies divided by methylated + unmethylated copies) x 100.
Time frame: Baseline and after 3 day of Vorinostat
Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment
To evaluate baseline and change in histone acetylation in polymononuclear cells in patients with primary breast cancer who received three days of SAHA 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment.
Time frame: Baseline and after 3 day of Vorinostat
Women enrolled from two sites, Johns Hopkins Medical Institutes and Anne Arundel Medical Center. Informed consent was obtained from all participants in the vorinostat and control groups.
| Milestone | Vorinostat | Tissue Only |
|---|---|---|
| Started | 25 | 29 |
| Completed | 24 | 25 |
| Not completed | 1 | 4 |
| Withdrew: Surgery delayed/tissue not collected | 1 | 4 |
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.
| participants | Vorinostat |
|---|---|
| Number of Participants With Adverse Events | 17 |
Change in Ki-67 (a marker of tissue proliferation) by IHC compared to baseline in the treated (22 evaluable samples) or untreated patients (15 evaluable samples) were analyzed between groups. Ki-67 is a protein in cells that increases as cellsprepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells.
| percentage of change | Vorinostat | Tissue Only |
|---|---|---|
| Change in Tissue Proliferation After 3 Days of Treatment | -3 (-62 to 38) | -4 (-32 to 46) |
Change in cleaved caspase-3 (a marker of tissue apoptosis) by IHC compared to baseline in the treated (19 evaluable samples) or untreated patients (12 evaluable samples) were analyzed between groups. Cleaved caspase-3 is a protein in cells involved in apoptosis (cell death).
| percentage of change | Vorinostat | Tissue Only |
|---|---|---|
| Change in Tissue Apoptosis After 3 Days of Treatment | 0 (-5 to 5) | 0 (-2 to 3) |
To evaluate change from baseline in tissue histone acetylation in patients with primary breast cancer who received three days of Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment. This is measured by Cumulative Methylation Index, which is reported as the sum of all %M for all genes. %M= (methylated copies divided by methylated + unmethylated copies) x 100.
| Cumulative Methylation Index | Arm I |
|---|---|
| Change in Tissue Histone Acetylation After 3 Days of Treatment | 38.3 |
To evaluate baseline and change in histone acetylation in polymononuclear cells in patients with primary breast cancer who received three days of SAHA 300 mg PO bid immediately prior to definitive breast surgery or other primary treatment.
No measurements were reported for this outcome.
Collected over Baseline and after 3 day of vorinostat. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vorinostat | — | 0/25 (0%) | 17/25 (68%) |
| Event | Vorinostat |
|---|---|
| DiarrheaGastrointestinal disorders | 7/25 |
| White blood cell decreasedInvestigations | 6/25 |
| FatigueGeneral disorders | 4/25 |
| DysgeusiaGastrointestinal disorders | 4/25 |
| NauseaGastrointestinal disorders | 4/25 |
| AnorexiaGastrointestinal disorders | 3/25 |
| HeadacheNervous system disorders | 1/25 |
| Age, Continuous(years) | Vorinostat | Tissue Only | Total |
|---|---|---|---|
| Median | 55 (34 to 71) | 52 (34 to 79) | 54 (34 to 79) |
| Age, Customized(years) | Vorinostat | Tissue Only | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| >18 years | 25 | 29 | 54 |
| Sex: Female, Male(Participants) | Vorinostat | Tissue Only | Total |
|---|---|---|---|
| Female | 25 | 29 | 54 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vorinostat | Tissue Only | Total |
|---|---|---|---|
| United States | 25 | 29 | 54 |
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)