AzTrials
AzTrials

Breast CancerPhase 1/2NCT01105312

Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer

A Phase 1/2 study testing letrozole, panobinostat and RNA analysis in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 172 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
letrozole, panobinostat and RNA analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
172 sitesUnited States
Study dates
Sep 2010to 3 Sep 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

172 sites in 1 country.

172 sites in 1 country

United States172 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncare Hawaii, Incorporated - Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncology Services of Aberdeen

    Aberdeen, South Dakota, 57401

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Florida Hospital Memorial Medical Center

    Daytona Beach, Florida, 32117

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Monter Cancer Center of the North Shore-LIJ Health System

    Lake Success, New York, 11042

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Study site

    Pismo Beach, California, 93449

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare - Princeton

    Princeton, Illinois, 61356

  • St. Mary - Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • St. Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • Illinois CancerCare - Spring Valley

    Spring Valley, Illinois, 61362

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Phase I/II Study of Panobinostat (LBH589) and Letrozole in Patients With Triple Negative Metastatic Breast Cancer

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.

Conditions
Breast Cancer
Being tested
letrozole, panobinostat, RNA analysis, microarray analysis, reverse transcriptase-polymerase chain reaction
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
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • letrozoleDrug

  • panobinostatDrug

  • RNA analysisGenetic

  • microarray analysisGenetic

  • reverse transcriptase-polymerase chain reactionGenetic

  • enzyme-linked immunosorbent assayOther

  • immunohistochemistry staining methodOther

  • laboratory biomarker analysisOther

Study groups in NCT01105312
Study groupRoleWhat they receive
panobinostat (LBH589) and letrozoleExperimentalEach 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

    Measured: from baseline up to 5 years post-registration

Secondary outcomes (7)

  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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: from baseline up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionAug 2013
  4. Study completion3 Sep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01105312
Sponsor's protocol ID
NCCTG-N093B
Other IDs
NCCTG-N093B, CDR0000669300, NCI-2011-02035
Status last verified
May 2017
First submitted
15 Apr 2010
Last updated
27 Jun 2017
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing letrozole, panobinostat and RNA analysis in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 172 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum-tolerated Dose (Phase I) (time frame: Up to 2.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01105312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in