Phase 2 Completed N=54 Treatment

Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer

Breast Cancer · Stage I Breast Cancer · Stage II Breast Cancer · Stage III Breast Cancer

Source: ClinicalTrials.gov NCT00262834 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcomePrimary: Number of Participants With Adverse Events — 17 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	17	—
PRIMARY Change in Tissue Proliferation After 3 Days of Treatment	-3; -4	0.42
PRIMARY Change in Tissue Apoptosis After 3 Days of Treatment	0; 0	0.50
SECONDARY Change in Tissue Histone Acetylation After 3 Days of Treatment	38.3	0.24
SECONDARY Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment	—	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00262834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.