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CompletedNCT01105312Updated Jun 27, 2017Results posted

Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer

A Phase 1/2 interventional study of letrozole and panobinostat in Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 172 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-27.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving panobinostat together with letrozole may be an effective treatment for breast cancer.

PURPOSE: This phase I/II trial is studying the side effects and best dose of panobinostat when given together with letrozole and to see how well it works in treating patients with metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary Objectives

  • To determine the maximum-tolerated dose of panobinostat in combination with letrozole in patients with metastatic breast cancer. (Phase I)
  • To determine the safety of this regimen in these patients. (Phase I)
  • To assess the confirmed response rate and safety profile of this regimen in patients with triple-negative disease. (Phase II)

Secondary Objectives

  • To assess the therapeutic effects of this regimen in these patients. (Phase I)
  • To examine the duration of response, clinical benefit rate, and time to treatment failure in patients treated with this regimen. (Phase II)
  • To examine the time to progression, progression-free survival, and overall survival of patients treated with this regimen. (Phase II)
  • To examine the estrogen, progesterone, and HER2 status of tumor at primary compared to metastatic tissue, and possibly after treatment. (exploratory)
  • To bank paraffin-embedded tissue blocks/slides and blood products for future studies. (exploratory)
  • To determine expression levels of biomarkers of treatment response (i.e., ER, PR, aromatase, NFkappaB, Ki67, and Caspase 3) in accessible tumors pre- and post-therapy via immunohistochemistry. (exploratory)
  • To determine whether ELISA for KLK11 in serum can be used as marker of activity of letrozole and LBH589. (exploratory) The Phase I portion of this study closed and the Phase II portion of the study opened as per NCCTG Addendum 6, effective January 23, 2012.

OUTLINE: This is a multicenter, phase I dose-escalation study of panobinostat followed by a phase II study. (The Phase I portion of this study closed and the Phase II portion of the study opened as per NCCTG Addendum 6, effective January 23, 2012.)

Patients receive oral panobinostat once daily on days 1, 3, and 5 in weeks 1-4 and oral letrozole once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Tumor tissue and blood samples are collected and banked for future biomarker and other analysis. Samples are also analyzed for biomarkers utilizing immunohistochemistry, microarray, reverse transcription-polymerase chain reaction (RT-PCR), and enzyme-linked immunosorbent assay (ELISA).

After completion of study therapy, patients are followed up every 3-6 months for up to 5 years.

02

Conditions studied

  • Breast Cancer

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Keywords

  • male breast cancer
  • estrogen receptor-negative breast cancer
  • estrogen receptor-positive breast cancer
  • HER2-negative breast cancer
  • HER2-positive breast cancer
  • progesterone receptor-negative breast cancer
  • progesterone receptor-positive breast cancer
  • triple-negative breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 28 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Metastatic disease amenable to biopsy
    • Unresected tumor with no intention to undergo resection during study
  • Archival tissue from the primary diagnosis or fresh biopsy from metastatic cancer site required

  • Measurable or non-measurable disease for phase I study (The Phase I portion of this study closed and the Phase II portion of the study opened as per NCCTG Addendum 6, effective January 23, 2012.)

    • Measurable disease only for phase II study

  • Available tumor estrogen (ER), progesterone (PR), and HER2 status from metastatic site tested by IHC or FISH OR results from the original tumor diagnosis

    • Any ER, PR, or HER2 level (positive or negative) acceptable (phase I)

    • Triple-negative disease only (phase II)

      • ER and PR negative defined as ≤ 1% by IHC

      • HER2 negative

        • Patients with triple-negative breast cancer allowed provided there is clinical or radiographic evidence of tumor progression in the adjuvant or metastatic setting
  • No patients whose disease can be treated with known standard therapy that is potentially curative or definitely capable of extending life expectancy
  • No known CNS metastasis

  • Hormone-receptor status:

    • ER and PR positive or negative (phase I)
    • ER and PR negative (phase II)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1 (phase I) or 0-2 (phase II)

  • Postmenopausal defined by 1 of the following:

    • ≥ 60 years of age
    • ≥ 45 years of age with last menstrual period ≥ 12 months prior and estradiol and follicle-stimulating hormone levels in postmenopausal range
    • Bilateral oophorectomy
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Total bilirubin normal
  • ALT and AST ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN if due to liver metastasis)
  • Serum creatinine ≤ 1.5 times ULN
  • TSH normal (thyroid hormone supplements allowed for patients with hypothyroidism)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Willing to return to Mayo Clinic or NCCTG institution (phase II) for follow-up
  • Willing to provide blood samples for correlative research purposes

  • No uncontrolled or intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • No NYHA class III or IV cardiovascular disease
  • No known seizure disorder
  • No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

  • No immunocompromised patients, including patients known to be HIV positive

    • Immunocompromised patients due to the use of corticosteroids allowed
  • No malignancy within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No history of myocardial infarction ≤ 6 months

  • No congenital long QT syndrome or QTcF>450 msec, including:

    • Complete left bundle block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (\<50 beats per minute)
    • Right bundle branch block + left anterior hemiblock (bifascicular block)
  • No congestive heart failure requiring use of maintenance therapy for life-threatening ventricular arrhythmias

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • More than 4 weeks since prior chemotherapy or radiotherapy and fully recovered

    • No radiotherapy to > 25 % of bone marrow

  • Prior treatments allowed (phase II):

    • 0 or 1 prior chemotherapy regimens for breast cancer
    • ≤ 2 prior aromatase-inhibitor regimens (including letrozole)
  • Not currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
  • No other concurrent investigational agent for the primary neoplasm
  • No concurrent CYP3A4 inhibitors or inducers
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    panobinostat (LBH589) and letrozole

    Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks. There are two phases of the study. The first phase determines the maximum tolerated dose for LBH589 in combination with letrozole. The second phase is to assess and confirm the response rate and safety profile of LBH589 in combination with letrozole.

    Drug: letrozole · Drug: panobinostat · Genetic: RNA analysis · Genetic: microarray analysis · Genetic: reverse transcriptase-polymerase chain reaction · Other: enzyme-linked immunosorbent assay · Other: immunohistochemistry staining method · Other: laboratory biomarker analysis

Interventions

  • Drugletrozole
  • Drugpanobinostat
  • GeneticRNA analysis
  • Geneticmicroarray analysis
  • Geneticreverse transcriptase-polymerase chain reaction
  • Otherenzyme-linked immunosorbent assay
  • Otherimmunohistochemistry staining method
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Maximum-tolerated Dose (Phase I)

    MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6\> new patients). If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT are seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. The number of DLT's will be reported here.

    Time frame: Up to 2.5 months

  2. Response Rate (Phase II)

    A confirmed response is defined to be a CR or PR (as determined by RECIST (version 1.1 criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. A CR is defined as: All of the following must be true: 1. Disappearance of all non-nodal target lesions 2. Each target lymph node must have reduction in short axis to \<1.0 cm A PR is defined as: At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the BSD (Section 11.41)

    Time frame: from baseline up to 5 years post-registration

Secondary outcomes

  1. Survival Time (Phase II)

    Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier

    Time frame: from baseline up to 5 years post-registration

  2. Time-to-disease Progression (Phase II)

    Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of TTP will be estimated using the method of Kaplan-Meier. Progression is defined as at least one of the following: 1. At least one new malignant lesion or a lymph node whose short axis has increased to \>1.5 cm 2. At least a 20% increase in the sum of diameters of target lesions taking as reference the MSD. In addition, the sum must also demonstrate an absolute increase of at least 0.5 cm

    Time frame: from baseline up to 6 months

  3. Progression-free Survival (Phase II)

    Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. PFS at 6 months will be estimated. The distribution of PFS will be estimated using the method of Kaplan-Meier.

    Time frame: from baseline up to 6 months

  4. Duration of Response (Phase II)

    Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

    Time frame: from baseline up to 5 years post-registration

  5. Clinical Benefit Rate

    Clinical benefit rate will be estimated by the total number of patients with an objective status of CR, PR, or SD for duration of at least 6 months divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.

    Time frame: from baseline up to 6 months

  6. Time to Treatment Failure

    Time to treatment failure (TTF) is defined as the time from the date of registration to the date at which the patient is removed from treatment due to progression, unacceptable adverse events, or refusal. The distribution of TTF will be estimated using the method of Kaplan-Meier

    Time frame: from baseline up to 5 years post-registration

  7. Confirmed Response Rate (Phase I)

    A confirmed response is defined to be a CR or PR (as determined by RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The number of confirmed responses will be reported here.

    Time frame: from baseline up to 5 years

07

Results

Posted Jun 27, 2017

Participant flow

Participant flow — Overall Study
MilestonePhase IIPhase I: Dose Level OnePhase I: Dose Level Two
Started1666
Completed1366
Not completed300

Outcome measures

PrimaryMaximum-tolerated Dose (Phase I)

MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6\> new patients). If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT are seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. The number of DLT's will be reported here.

Time frame:
Up to 2.5 months
Reported as:
Count of participants · Participants
Maximum-tolerated Dose (Phase I)
ParticipantsPhase I: Dose Level OnePhase I: Dose Level Two
Maximum-tolerated Dose (Phase I)13
PrimaryResponse Rate (Phase II)

A confirmed response is defined to be a CR or PR (as determined by RECIST (version 1.1 criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. A CR is defined as: All of the following must be true: 1. Disappearance of all non-nodal target lesions 2. Each target lymph node must have reduction in short axis to \<1.0 cm A PR is defined as: At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the BSD (Section 11.41)

Time frame:
from baseline up to 5 years post-registration
Reported as:
Number · percentage of participants
Response Rate (Phase II)
percentage of participantsPhase II
Response Rate (Phase II)0 (0 to 24.7)
SecondarySurvival Time (Phase II)

Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier

Time frame:
from baseline up to 5 years post-registration
Reported as:
Median · months
Survival Time (Phase II)
monthsPhase II
Survival Time (Phase II)16.1 (13.4 to NA)
SecondaryTime-to-disease Progression (Phase II)

Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of TTP will be estimated using the method of Kaplan-Meier. Progression is defined as at least one of the following: 1. At least one new malignant lesion or a lymph node whose short axis has increased to \>1.5 cm 2. At least a 20% increase in the sum of diameters of target lesions taking as reference the MSD. In addition, the sum must also demonstrate an absolute increase of at least 0.5 cm

Time frame:
from baseline up to 6 months
Reported as:
Median · months
Time-to-disease Progression (Phase II)
monthsPhase II
Time-to-disease Progression (Phase II)2.1 (1.5 to NA)
SecondaryProgression-free Survival (Phase II)

Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. PFS at 6 months will be estimated. The distribution of PFS will be estimated using the method of Kaplan-Meier.

Time frame:
from baseline up to 6 months
Reported as:
Median · months
Progression-free Survival (Phase II)
monthsPhase II
Progression-free Survival (Phase II)2.1 (1.5 to NA)
SecondaryDuration of Response (Phase II)

Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

Time frame:
from baseline up to 5 years post-registration
Reported as:
Median · months
Duration of Response (Phase II)
monthsPhase II
Duration of Response (Phase II)NA (NA to NA)
SecondaryClinical Benefit Rate

Clinical benefit rate will be estimated by the total number of patients with an objective status of CR, PR, or SD for duration of at least 6 months divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.

Time frame:
from baseline up to 6 months
Reported as:
Number · percentage of participants
Clinical Benefit Rate
percentage of participantsPhase II
Clinical Benefit Rate0 (0 to 24.7)
SecondaryTime to Treatment Failure

Time to treatment failure (TTF) is defined as the time from the date of registration to the date at which the patient is removed from treatment due to progression, unacceptable adverse events, or refusal. The distribution of TTF will be estimated using the method of Kaplan-Meier

Time frame:
from baseline up to 5 years post-registration
Reported as:
Median · months
Time to Treatment Failure
monthsPhase II
Time to Treatment Failure2 (1.1 to NA)
SecondaryConfirmed Response Rate (Phase I)

A confirmed response is defined to be a CR or PR (as determined by RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The number of confirmed responses will be reported here.

Time frame:
from baseline up to 5 years
Reported as:
Count of participants · Participants
Confirmed Response Rate (Phase I)
ParticipantsPhase I: Dose Level OnePhase I: Dose Level Two
Confirmed Response Rate (Phase I)02

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase II—4/16 (25%)13/16 (81.3%)
Phase I: Dose Level One—1/6 (16.7%)6/6 (100%)
Phase I: Dose Level Two—2/6 (33.3%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventPhase IIPhase I: Dose Level OnePhase I: Dose Level Two
Platelet count decreasedInvestigations3/160/60/6
Bladder infectionInfections and infestations0/161/60/6
HypokalemiaMetabolism and nutrition disorders0/160/61/6
HyponatremiaMetabolism and nutrition disorders0/160/61/6
Lung infectionInfections and infestations1/160/60/6
FractureInjury, poisoning and procedural complications1/160/60/6
White blood cell decreasedInvestigations1/160/60/6
Most frequent other events
Showing 10 of 33
Most frequent other events
EventPhase IIPhase I: Dose Level OnePhase I: Dose Level Two
Neutrophil count decreasedInvestigations4/163/66/6
Platelet count decreasedInvestigations9/165/66/6
White blood cell decreasedInvestigations5/165/64/6
AnemiaBlood and lymphatic system disorders9/164/62/6
Creatinine increasedInvestigations5/163/64/6
HypocalcemiaMetabolism and nutrition disorders6/162/64/6
HypermagnesemiaMetabolism and nutrition disorders2/163/62/6
NauseaGastrointestinal disorders2/160/62/6
FatigueGeneral disorders2/161/62/6
Blood bilirubin increasedInvestigations1/160/62/6

Baseline characteristics

All phase I and phase II patients were used for baseline analysis

Age, Categorical
Age, Categorical(Participants)Phase IIPhase I: Dose Level OnePhase I: Dose Level TwoTotal
<=18 years0000
Between 18 and 65 years113418
>=65 years53210
Age, Continuous
Age, Continuous(years)Phase IIPhase I: Dose Level OnePhase I: Dose Level TwoTotal
Median60.5 (43 to 75)66 (56 to 75)63 (43 to 68)62.5 (43 to 75)
Sex: Female, Male
Sex: Female, Male(Participants)Phase IIPhase I: Dose Level OnePhase I: Dose Level TwoTotal
Female166628
Male0000
Region of Enrollment
Region of Enrollment(participants)Phase IIPhase I: Dose Level OnePhase I: Dose Level TwoTotal
United States166628
08

Study locations

172 sites
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259-5499, United States
  • Contra Costa Regional Medical Center
    Martinez, California 94553-3156, United States
  • El Camino Hospital Cancer Center
    Mountain View, California 94040, United States
  • Bay Area Breast Surgeons, Incorporated
    Oakland, California 94609, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609, United States
  • Larry G Strieff MD Medical Corporation
    Oakland, California 94609, United States
  • Tom K Lee, Incorporated
    Oakland, California 94609, United States
  • Pismo Beach, California 93449, United States
  • Doctors Medical Center - San Pablo Campus
    San Pablo, California 94806, United States
  • Aurora Presbyterian Hospital
    Aurora, Colorado 80012, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301-9019, United States
  • Penrose Cancer Center at Penrose Hospital
    Colorado Springs, Colorado 80933, United States
  • St. Anthony Central Hospital
    Denver, Colorado 80204, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Presbyterian - St. Luke's Medical Center
    Denver, Colorado 80218, United States
  • St. Joseph Hospital
    Denver, Colorado 80218, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Swedish Medical Center
    Englewood, Colorado 80110, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Front Range Cancer Specialists
    Fort Collins, Colorado 80528, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Hope Cancer Care Center at Longmont United Hospital
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • St. Mary - Corwin Regional Medical Center
    Pueblo, Colorado 81004, United States
  • North Suburban Medical Center
    Thornton, Colorado 80229, United States
  • Exempla Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    Hartford, Connecticut 06105, United States
  • Florida Hospital Memorial Medical Center
    Daytona Beach, Florida 32117, United States
  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Memorial Cancer Institute at Memorial Regional Hospital
    Hollywood, Florida 33021, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
    Jupiter, Florida 33458, United States
  • CCOP - Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • John B. Amos Cancer Center
    Columbus, Georgia 31904, United States
  • Kapiolani Medical Center at Pali Momi
    'Aiea, Hawaii 96701, United States
  • Oncare Hawaii, Incorporated - Pali Momi
    'Aiea, Hawaii 96701, United States
  • Cancer Research Center of Hawaii
    Honolulu, Hawaii 96813, United States
  • OnCare Hawaii, Incorporated - Lusitana
    Honolulu, Hawaii 96813, United States
  • Queen's Cancer Institute at Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Straub Clinic and Hospital, Incorporated
    Honolulu, Hawaii 96813, United States
  • Kuakini Medical Center
    Honolulu, Hawaii 96817, United States
  • OnCare Hawaii, Incorporated - Kuakini
    Honolulu, Hawaii 96817, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Castle Medical Center
    Kailua, Hawaii 96734, United States
  • Kauai Medical Clinic
    Lihue, Hawaii 96766, United States
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
    Boise, Idaho 83706, United States
  • Illinois CancerCare - Bloomington
    Bloomington, Illinois 61701, United States
  • St. Joseph Medical Center
    Bloomington, Illinois 61701, United States
  • Illinois CancerCare - Canton
    Canton, Illinois 61520, United States
  • Illinois CancerCare - Carthage
    Carthage, Illinois 62321, United States
  • Resurrection Medical Center
    Chicago, Illinois 60631, United States
  • Louis A. Weiss Memorial Hospital
    Chicago, Illinois 60640, United States
  • Eureka Community Hospital
    Eureka, Illinois 61530, United States
  • Illinois CancerCare - Eureka
    Eureka, Illinois 61530, United States
  • Galesburg Clinic, PC
    Galesburg, Illinois 61401, United States
  • Illinois CancerCare - Havana
    Havana, Illinois 62644, United States
  • Illinois CancerCare - Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • Illinois CancerCare - Macomb
    Macomb, Illinois 61455, United States
  • Illinois CancerCare - Monmouth
    Monmouth, Illinois 61462, United States
  • OSF Holy Family Medical Center
    Monmouth, Illinois 61462, United States
  • BroMenn Regional Medical Center
    Normal, Illinois 61761, United States
  • Community Cancer Center
    Normal, Illinois 61761, United States
  • Illinois CancerCare - Community Cancer Center
    Normal, Illinois 61761, United States
  • Community Hospital of Ottawa
    Ottawa, Illinois 61350, United States
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
    Ottawa, Illinois 61350, United States
  • Cancer Treatment Center at Pekin Hospital
    Pekin, Illinois 61554, United States
  • Illinois CancerCare - Pekin
    Pekin, Illinois 61603, United States
  • Proctor Hospital
    Peoria, Illinois 61614, United States
  • CCOP - Illinois Oncology Research Association
    Peoria, Illinois 61615, United States
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
    Peoria, Illinois 61615, United States
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61636, United States
  • OSF St. Francis Medical Center
    Peoria, Illinois 61637, United States
  • Illinois CancerCare - Peru
    Peru, Illinois 61354, United States
  • Illinois Valley Community Hospital
    Peru, Illinois 61354, United States
  • Illinois CancerCare - Princeton
    Princeton, Illinois 61356, United States
  • Illinois CancerCare - Spring Valley
    Spring Valley, Illinois 61362, United States
  • McFarland Clinic, PC
    Ames, Iowa 50010, United States
  • Cancer Center of Kansas, PA - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas, PA - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas, PA - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas - Fort Scott
    Fort Scott, Kansas 66701, United States
  • Cancer Center of Kansas-Independence
    Independence, Kansas 67301, United States
  • Cancer Center of Kansas, PA - Kingman
    Kingman, Kansas 67068, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Cancer Center of Kansas, PA - Liberal
    Liberal, Kansas 67901, United States
  • Cancer Center of Kansas, PA - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas, PA - Parsons
    Parsons, Kansas 67357, United States
  • Cancer Center of Kansas, PA - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas, PA - Salina
    Salina, Kansas 67401, United States
  • Cancer Center of Kansas, PA - Wellington
    Wellington, Kansas 67152, United States
  • Associates in Womens Health, PA - North Review
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Wichita
    Wichita, Kansas 67214, United States
  • CCOP - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas, PA - Winfield
    Winfield, Kansas 67156, United States
  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    Baltimore, Maryland 21215, United States
  • Peninsula Regional Medical Center
    Salisbury, Maryland 21801, United States
  • Hickman Cancer Center at Bixby Medical Center
    Adrian, Michigan 49221, United States

Showing the first 100 of 172 sites.

09

References and documents

Publications

  • Tan WW, Allred JB, Moreno-Aspitia A, Northfelt DW, Ingle JN, Goetz MP, Perez EA. Phase I Study of Panobinostat (LBH589) and Letrozole in Postmenopausal Metastatic Breast Cancer Patients. Clin Breast Cancer. 2016 Apr;16(2):82-6. doi: 10.1016/j.clbc.2015.11.003. Epub 2015 Nov 17. PubMed 26774555 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01105312
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 16, 2010
Start date
Sep 2010
Primary completion
Aug 2013
Completion
Sep 3, 2013
Results posted
Jun 27, 2017
Last update
Jun 27, 2017

Study contacts

Winston Tan, MD, FACP
study chair · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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