Phase I/II Study of Panobinostat (LBH589) and Letrozole in Patients With Triple Negative 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (phase I)
Yes
Winston Tan, MD, FACP
Principal Investigator
Mayo Clinic
Unspecified
CDR0000669300
NCT01105312
September 2010
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
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 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
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 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Eureka Community Hospital | Eureka, Illinois 61530 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Oncology Services of Aberdeen | Aberdeen, South Dakota 57401 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
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 - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Monter Cancer Center of the North Shore-LIJ Health System | Lake Success, New York 11042 |
Hematology Oncology Center | Elyria, Ohio 44035 |
Community Cancer Center | Elyria, Ohio 44035 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Resurrection Medical Center | Chicago, Illinois 60631 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Carthage | Carthage, Illinois 62321 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Havana | Havana, Illinois 62644 |
Illinois CancerCare - Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
OSF Holy Family Medical Center | Monmouth, Illinois 61462 |
Illinois CancerCare - Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Pekin | Pekin, Illinois 61603 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Princeton | Princeton, Illinois 61356 |
Illinois CancerCare - Spring Valley | Spring Valley, Illinois 61362 |
Fountain Valley, California 92708 | |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
Florida Hospital Memorial Medical Center | Daytona Beach, Florida 32117 |
Castle Medical Center | Kailua, Hawaii 96734 |
Kauai Medical Clinic | Lihue, Hawaii 96766 |
Lakeside Hospital | Omaha, Nebraska 68130 |
St. Nicholas Hospital | Sheboygan, Wisconsin 53081 |
Kuakini Medical Center | Honolulu, Hawaii 96817 |
Oncare Hawaii, Incorporated - Pali Momi | Aiea, Hawaii 96701 |