Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer
OBJECTIVES:
- To assess whether mammographic density is reduced in premenopausal women at high risk
of breast cancer taking high-dose vitamin D3 (oral cholecalciferol 20,000 IU weekly) vs
placebo for 1 year.
- To assess whether proliferation as measured by Ki-67 staining of breast epithelial
cells is reduced in women receiving these treatments.
- To explore the difference in the expression of other biomarkers (including cleaved
caspase-3 [apoptosis marker], ER, vitamin D receptor [VDR], and 1α-hydroxylase) in
breast tissue obtained from these women.
- To assess whether parathyroid hormone, IGF-1, IGFBP-3, 25(OH)D, and 1,25(OH)D serum
levels are altered in these women at baseline and at 6 and 12 months.
- To explore whether a change in mammographic density correlates with polymorphisms in
the VDR gene.
- To assess other sources of vitamin D (sunlight exposure, diet) in these women using a
validated questionnaire administered at baseline and at 12 and 24 months.
- To collect and bank serum, plasma, and breast tissue from these women before and after
a 1-year intervention with vitamin D for future biomarker analysis.
- To assess the toxicity of high-dose cholecalciferol compared to placebo in this
setting.
OUTLINE: This is a multicenter study. Participants are stratified according to baseline
serum 25(OH)D level (< 20 ng/mL vs 20-32 ng/mL or < 50 nmol/L vs 50-80 nmol/L), baseline
mammographic density (11-50% vs > 50%), and designated biopsy site (yes vs no). Participants
are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive oral cholecalciferol once weekly and oral vitamin D once
daily. Treatment repeats for 12 months in the absence of evidence of cancer or
unacceptable toxicity.
- Arm II: Participants receive oral placebo once weekly and oral vitamin D once daily.
Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable
toxicity.
Blood samples are collected at baseline and periodically thereafter for biomarkers and
25(OH)D level. Participants undergo a mammogram at baseline and at 12 months. Participants
may also undergo random core-needle breast biopsy at baseline and at 12 months.
Participants complete a questionnaire at baseline and at 12 and 24 months.
After completion of study therapy, participants are followed up at 1 and 12 months.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Change in mammographic density at 12 months compared to baseline
12 months
No
Laurence H. Baker, DO, FACOI
Principal Investigator
Southwest Oncology Group - Group Chair's Office
United States: Food and Drug Administration
CDR0000668698
NCT01097278
November 2011
July 2015
Name | Location |
---|---|
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
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 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Greenville | Greenville, South Carolina 29615 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Winthrop University Hospital | Mineola, New York 11501 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Highland General Hospital | Oakland, California 94602 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
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 |
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 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
Legacy Salmon Creek Medical Center | Vancouver, Washington 98686 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Methodist Hospital | Houston, Texas 77030 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Greer Medical Oncology | Greer, South Carolina 29650 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Phelps County Regional Medical Center | Rolla, Missouri 65401 |
Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center | Normal, Illinois 61761 |
Rockwood Clinic Cancer Treatment Center | Spokane, Washington 99204-2967 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Midwest Hematology Oncology Group, Incorporated | Saint Louis, Missouri 63109 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
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 |
Caritas St. Elizabeth's Medical Center | Brighton, Massachusetts 02135-2997 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Lovelace Medical Center - Downtown | Albuquerque, New Mexico 87102 |
Regional Medical Center | Anniston, Alabama 36202 |
Cancer Centers of the Carolinas - Easley | Easley, South Carolina 29640 |
Self Regional Cancer Center at Self Regional Medical Center | Greenwood, South Carolina 29646 |
Cancer Centers of the Carolinas - Greer Radiation Oncology | Greer, South Carolina 29650 |
Falck Cancer Center at Arnot Ogden Medical Center | Elmira, New York 14905 |
Castle Medical Center | Kailua, Hawaii 96734 |
Kauai Medical Clinic | Lihue, Hawaii 96766 |
Central Dupage Cancer Center | Warrenville, Illinois 60555 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
Providence Newberg Medical Center | Newberg, Oregon 97132 |
Willamette Falls Hospital | Oregon City, Oregon 97045 |
Southern Ohio Medical Center Cancer Center | Portsmouth, Ohio 45662 |
Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |
Kuakini Medical Center | Honolulu, Hawaii 96817 |
Mountain States Tumor Institute - Meridian | Meridian, Idaho 83642 |
Mountain States Tumor Institute at St. Luke's | Twin Falls, Idaho 83301 |
Central Care Cancer Center at Carrie J. Babb Cancer Center | Bolivar, Missouri 65613 |
Carolina Blood and Cancer Care | Rock Hill, South Carolina 29732 |
Mercy Clinic Cancer and Hematology - Rolla | Rolla, Missouri 65401 |
Oncare Hawaii, Incorporated - Pali Momi | Aiea, Hawaii 96701 |
Epic Care - Oakland | Oakland, California 94612 |
Delnor Hospital - Geneva | Geneva, Illinois 60134 |