Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2010

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
173
sites
7500 Mercy Rd
Omaha, Nebraska 68124
(402) 398-6060
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2401 West Belvedere Avenue
Baltimore, Maryland 21215
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Alvin and Lois Lapidus Cancer Institute at Sinai Hospital The Alvin & Lois Lapidus Cancer...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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115 Business loop 70 w
Columbia, Missouri 65203
(573) 882-2100
Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
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100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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1719 East 19th Avenue
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 492-5764
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
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1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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1150 N 35th Ave # 330
Hollywood, Florida 33021
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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1240 S Old Dixie Hwy
Jupiter, Florida 33458
(561) 263-4400
Ella Milbank Foshay Cancer Center at Jupiter Medical Center The Foshay Cancer Center is one...
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1900 South Avenue
La Crosse, Wisconsin 54601
(608) 782-7300
Gundersen Lutheran Center for Cancer and Blood Gundersen Health System is where caring meets excellence...
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4300 Alton Road
Miami Beach, Florida 33140
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1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
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800 NE 10th Street
Oklahoma City, Oklahoma 73104
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825 N Emporia Ave
Wichita, Kansas 67214
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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Aberdeen, South Dakota 57401
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777 Kimole Ln
Adrian, Michigan 49221
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Ames, Iowa 50010
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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364 White Oak St
Asheboro, North Carolina 27203
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Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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700 Potomac St
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900 E Broadway Ave
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720 E Rosser Ave
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900 East Broadway
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2200 E Washington St,
Bloomington, Illinois 61701
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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1055 N Curtis Rd
Boise, Idaho 83706
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1100 Balsam Ave
Boulder, Colorado 80304
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Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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960 W. Wooster
Bowling Green, Ohio 43402
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Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
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Chicago, Illinois 60640
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Chicago, Illinois 60631
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
(719) 776-5000
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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142 S Main St
Danville, Virginia 24541
(434) 799-2100
Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
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Daytona Beach, Florida 32117
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18101 Oakwood Blvd
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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11600 W 2nd Pl
Denver, Colorado 80204
(720) 321-0000
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Denver, Colorado 80218
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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5008 Brittonfield Parkway
East Syracuse, New York 13057
(315) 472-7504
CCOP - Hematology-Oncology Associates of Central New York Hematology/Oncology Associates of CNY (HOACNY) has participated...
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700 West Central
El Dorado, Kansas 67042
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41201 Schadden Rd
Elyria, Ohio 44035
(440) 324-0480
Community Cancer Center When you have cancer, you might think first of treatments
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6282 Linton Blvd
Elyria, Ohio 44035
(561) 495-8307
Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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101 S Major St
Eureka, Illinois 61530
309-467-2371
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101 S Major St
Eureka, Illinois 61530
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
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1024 S Lemay Ave
Fort Collins, Colorado 80524
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Fort Scott, Kansas 66701
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Fredericksburg, Virginia 22401
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3315 N. Seminary Street
Galesburg, Illinois 61401
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Goldsboro, North Carolina 27534
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960 S. Columbia Rd.
Grand Forks, North Dakota 58201
701-780-5400
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1801 16th St
Greeley, Colorado 80631
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114 Woodland St, Hartford
Hartford, Connecticut 06105
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520 E. Franklin
Havana, Illinois 62644
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1740 E Broad St
Hazleton, Pennsylvania 18201
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800 N Justice St
Hendersonville, North Carolina 28791
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1301 Punchbowl Street
Honolulu, Hawaii 96813
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Queen's Cancer Institute at Queen's Medical Center The Queen
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1329 Lusitana St. Ste 307
Honolulu, Hawaii 96813
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1319 Punahou St
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347 N Kuakini St
Honolulu, Hawaii 96817
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Honolulu, Hawaii 96817
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
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205 North East Avenue
Jackson, Michigan 49201
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Jacksonville, Florida 32216
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640 Ulukahiki St,
Kailua, Hawaii 96734
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205 Tenney St
Kewanee, Illinois 61443
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-2890
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325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
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315 W. 15th St.
Liberal, Kansas 67905
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Lihue, Hawaii 96766
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1001 Bellefontaine Ave
Lima, Ohio 45804
(419) 228-3335
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Lima, OH
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4600 Valley Rd # 336
Lincoln, Nebraska 68510
(402) 483-2827
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Lincoln, NE
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36475 Five Mile
Livonia, Michigan 48154
734-655-4800
St. Mary Mercy Hospital St. Mary Mercy Hospital, located at 36475 Five Mile Road at...
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Livonia, MI
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10101 RidgeGate Pkwy
Lone Tree, Colorado 80124
720) 225-1000
Sky Ridge Medical Center HealthONE is the largest healthcare system in the metro Denver area...
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Lone Tree, CO
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1950 Mountain View Ave
Longmont, Colorado 80501
303.651.5111
Hope Cancer Care Center at Longmont United Hospital Patients treated at the Hope Cancer Care...
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Longmont, CO
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2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
McKee Medical Center Through the years, McKee has led the way in health care innovation....
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Loveland, CO
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501 E Grant
Macomb, Illinois 61455
309-833-3503
Illinois CancerCare - Macomb Illinois CancerCare is one of the largest private oncology and hematology...
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Macomb, IL
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