N/A
Completed N=8
Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Aromatase Inhibitor Therapy
male breast cancer · Recurrent Breast Cancer · Stage IV Breast Cancer
Source: ClinicalTrials.gov NCT01153672 ↗
Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Nov 2014
Primary outcomePrimary: Rate of Clinical Benefit According to RECIST — 15 percentage of evaluable participants
Summary
This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving aromatase inhibitor (AI) therapy. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help AI therapy work better by making tumor cells more sensitive to the drug
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Clinical Benefit According to RECIST |
15 | — |
| PRIMARY Duration of Response |
25.4 | — |
| SECONDARY Progression-free Survival |
2.8 | — |
| SECONDARY Overall Survival |
28.8 | — |
| SECONDARY Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |
37.5 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically proven diagnosis of breast cancer
- Stage IV disease
- Patient has previously derived clinical benefit from endocrine therapy, but is no longer deriving benefit to endocrine therapy in the opinion of the treating investigator; patients need to stop AI for at least one week prior to starting vorinostat treatment on this protocol
- At least one site of measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Female patient is post menopausal as defined by one of the following; free from menses for > 2 years, surgically sterilized ,FSH and Estradiol in post-menopausal range AND surgical absence of uterus OR chemotherapy induced amenorrhea lasting > 1 year OR currently on ovarian suppression
- Female patient of childbearing potential has a negative urine or serum (beta-human chorionic gonadotropin [hCG]) pregnancy test within 14 days prior to receiving the first dose of vorinostat
- Male patient agrees to use two barrier methods of contraception or abstain from intercourse for the duration of the study
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9 g/dL
- Prothrombin Time or international normalized ratio (INR) = = 30 mL/min
- Serum total bilirubin = 0.47 seconds, or uncontrolled arrhythmia.
- Type I Diabetes Mellitus; patients with Type II Diabetes Mellitus will be included as long as their glucose can be controlled to under 200 mg/dL
- Patient is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study
- Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years or are considered by their physician to be at less than 30% risk of relapse
- Patients with known active viral hepatitis
- Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate
Data sourced from ClinicalTrials.gov (NCT01153672). 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.