Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy

NCT01720602 | Completed Results

• 3 other identifiers: 7841NCI-2012-02004P30CA015704
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies vorinostat in treating patients with stage IV breast cancer receiving hormone therapy. Vorinostat may help hormone therapy work better by making tumor cells more sensitive to the drug.

Conditions

Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST

  A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit. Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).

  8 weeks

• Response Rate According to RECIST

  A 90% score (Wilson) confidence interval will be computed for the response rate. Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more).

  8 weeks

Secondary Outcomes (3)

• Duration of Response

  Up to 5 years

• Progression-free Survival (PFS)

  From the time of start of study therapy to documented progression - up to 5 years

• Overall Survival

  From the time of start of study therapy to date of documented death

Study Arms (1)

Treatment (vorinostat, AI therapy)

EXPERIMENTAL

Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.

Drug: vorinostat; Drug: anastrozole; Drug: letrozole; Drug: exemestane; Procedure: positron emission tomography; Radiation: F-18 16 alpha-fluoroestradiol; Radiation: fludeoxyglucose F 18; Other: laboratory biomarker analysis

Interventions

vorinostat DRUG

Given PO

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza

Treatment (vorinostat, AI therapy)

anastrozole DRUG

Given PO

Also known as: ANAS, Arimidex, ICI-D1033

Treatment (vorinostat, AI therapy)

letrozole DRUG

Given PO

Also known as: CGS 20267, Femara, LTZ

Treatment (vorinostat, AI therapy)

exemestane DRUG

Given PO

Also known as: Aromasin, FCE-24304, PNU 155971

Treatment (vorinostat, AI therapy)

positron emission tomography PROCEDURE

Correlative studies

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Treatment (vorinostat, AI therapy)

F-18 16 alpha-fluoroestradiol RADIATION

Correlative studies

Also known as: F-18 FES, fluorine-18 16 alpha-fluoroestradiol

Treatment (vorinostat, AI therapy)

fludeoxyglucose F 18 RADIATION

Correlative studies

Also known as: 18FDG, FDG

Treatment (vorinostat, AI therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (vorinostat, AI therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 \[B-hCG\]) 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 \>= 50,000/mcL
• Hemoglobin \>= 9 g/dL
• Prothrombin time or international normalized ratio (INR) =\< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation
• Partial thromboplastin time (PTT) =\< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation
• Potassium (K) levels normal limits
• Magnesium (Mg) levels normal limits

You may not qualify if:

• Patient has not derived clinical benefit from prior endocrine therapy
• Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s) other than the imaging protocol 7184
• Patient has received an ER blocking therapy (selective estrogen receptor modulating or downregulating selective estrogen receptor modulator \[SERM\] or selective estrogen receptor degrader \[SERD\] i.e. tamoxifen or fulvestrant) within the past 6 weeks
• Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidepsin \[Depsipeptide\], NSC-630176, MS 275, LAQ-824, belinostat (PXD-101), LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period
• Patient is on any systemic steroids that have not been stabilized to the equivalent of =\< 10 mg/day prednisone during the 30 days prior to the start of the study drugs
• Patient has known hypersensitivity to the components of study drug or its analogs
• Patients with uncontrolled brain metastases
• New York Heart Association (NYHA) class III or IV congestive heart failure, myocardial infarction within the previous 6 months, QTc \> 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 laboratory (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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

Vorinostat; Anastrozole; Letrozole; exemestane; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Hannah Linden, MD
• Organization: University of Washington

hmlinden@u.washington.edu

206-288-6989

Study Officials

• Hannah Linden

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: January 1, 2020
• Last Updated: January 7, 2020
• Results First Posted: November 6, 2014

Record last verified: 2020-01

Locations

US (1)