In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, PreventionActive18 to 50NCI, OtherS0812
U10CA037429, NCI-2011-02032, SWOG-S0812, NCT01097278

Trial Description

Summary

RATIONALE: Cholecalciferol may prevent breast cancer in premenopausal women.

PURPOSE: This randomized phase II trial is studying how well cholecalciferol works in preventing breast cancer in premenopausal women.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • At an elevated risk of breast cancer by at least one of the following criteria:
  • Diagnosis of ADH, ALH, lobular carcinoma in situ (LCIS) or resected ductal carcinoma in situ (DCIS) or small invasive breast cancers (pTmi or pT1a N0) if no pior RT, tamoxifen, or systemic breast cancer treatment within 28 days prior to registration OR diagnosis of resected Stage I (T1b-c N0-N1mi) through Stage II breast cancer for which the participant has been disease-free for at least 5 years and has completed all adjuvant treatment OR
  • A known* deleterious mutation in BRCA1, BRCA2, PTEN, or TP53 NOTE: *The participant must be a documented carrier to meet this criterion. If there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per NCCN clinical guidelines to be eligible per this criterion.
  • Modified Gail Model/CARE model** risk at 5 years ≥ 1.67% or lifetime risk ≥ 20% by Claus, BRCAPro, Tyrer-Cuzick or IBIS models OR
  • Mammographic density ≥ 50% (heterogenously dense) NOTE: **Risk models are to be used only if there is no known previous diagnosis of resected DCIS or LCIS and there is no known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53.
  • At least one breast available for imaging and biopsy (a previously irradiated breast [i.e., for resected DCIS] is not evaluable for breast imaging or biopsy)
  • Baseline mammogram (performed within 10 days after starting their last menstrual period on a digital mammography machine) that shows either normal or benign findings
  • Baseline mammographic density > 10% based upon the classification system (2 = 11-50%, "scattered fibroglandular densities"; 3 = 51-75%, "heterogeneously dense"; 4 = >75, "extremely dense". Women with a baseline mammographic density of ≤ 10% (1 = ≤ 10% breasts are almost entirely fat)will not be eligible.

PATIENT CHARACTERISTICS:

  • Premenopausal, defined as ≥ 1 of the following criteria:
  • Less than 6 months since the last menstrual period, no prior bilateral oophorectomy, and no use of hormone-replacement therapy
  • Has undergone a prior hysterectomy but no prior bilateral oophorectomy AND follicle-stimulating hormone values measured within the past 28 days are consistent with the normal values for the premenopausal state
  • Zubrod performance status 0-1
  • Serum creatinine ≤ upper limit of normal (ULN)
  • Serum calcium or corrected calcium ≤ ULN
  • Spot urine calcium:creatinine ratio < 0.37 mg/dL
  • INR ≤ 1.5 times ULN+
  • PT and PTT ≤ ULN*
  • Baseline serum 25(OH)D level ≤ 32 ng/mL (or 80 nmol/L)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except for the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Adequately treated stage I or II (including resected Stage I, T1b-c N0-N1mi through Stage II breast cancer) from which the participant is currently in complete remission
  • Any other cancer (including contralateral breast) for which the participant has been disease-free for ≥ 5 years
  • No history of kidney stones
  • No medical conditions requiring calcium or vitamin D supplementation (i.e., osteoporosis)
  • No known hypersensitivity to vitamin D
  • No known allergy to soy NOTE: +For patients undergoing breast biopsy.

PRIOR CONCURRENT THERAPY:

  • Prior breast reduction surgery allowed
  • No bilateral breast implants
  • More than 1 month since prior surgery or radiotherapy to the breast for resected DCIS
  • At least 28 days since prior tamoxifen
  • Prior anticoagulant therapy allowed provided it is discontinued ≥ 7 days before breast biopsy
  • No concurrent calcium or additional vitamin D supplements
  • Concurrent multivitamins allowed provided that the dose of vitamin D in the multivitamin does not exceed 400 IU daily
  • No concurrent participation in any other clinical trial for the treatment or prevention of cancer unless the participant is no longer receiving the intervention and is in the follow-up phase only (participants must not join such a trial while participating in this study)

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

National Cancer Institute

Katherine D. Crew, MD, MSPrincipal Investigator

Patricia O'KanePh: 2106148808 Ext.1011
  Email: pokane@swog.org

Trial Sites

U.S.A.
Alabama
  Mobile
 Providence Cancer Center at Providence Hospital
 Thaddeus A Beeker Ph: 877-904-4367
Arkansas
  Rogers
 Highlands Oncology Group - Bentonville
 Joseph Thaddeus Beck Ph: 800-381-6939
California
  Castro Valley
 East Bay Radiation Oncology Center
 James H. Feusner Ph: 510-450-7600
  Concord
 Cancer Care Center at John Muir Health - Concord Campus
 Deborah L. Kerlin Ph: 925-674-2580
  Dublin
 Epic Care-Dublin
 James H. Feusner Ph: 510-450-7600
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Agustin Garcia Ph: 323-865-0451
 Agustin Garcia Ph: 323-865-0451
  Oakland
 Bay Area Breast Surgeons, Incorporated
 James H. Feusner Ph: 510-450-7600
 Larry G Strieff MD Medical Corporation
 James H. Feusner Ph: 510-450-7600
  Pleasant Hill
 East Bay Medical Oncology Hematology Associates - Pleasant Hill
 James H. Feusner Ph: 510-450-7600
  Santa Ana
 Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
 John S. Link Ph: 562-981-6101
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Deborah L. Kerlin Ph: 925-674-2580
  Whittier
 Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
 Dustin E Stevenson Ph: 562-698-0811
Florida
  Stuart
 Robert and Carol Weissman Cancer Center at Martin Memorial
 James J. Vopal Ph: 772-288-5858ext4
 James J. Vopal Ph: 772-288-5858ext4
 James J. Vopal Ph: 772-288-5858ext4
Georgia
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Jayanthi Srinivasiah Ph: 404-501-3279
Hawaii
  Honolulu
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
Illinois
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Decatur
 CCOP - Central Illinois
 Katherine D Crew
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon Ph: 574-234-5123
 Elkhart General Hospital
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Robin Zon Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Robin Zon Ph: 574-234-5123
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Robin Zon Ph: 574-234-5123
 Saint Joseph's Medical Center
 Robin Zon Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Robin Zon Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon Ph: 574-234-5123
 Memorial Hospital of South Bend
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon Ph: 574-234-5123
 South Bend Clinic
 Robin Zon Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology-PC Westville
 Robin Zon Ph: 574-234-5123
Kansas
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  McPherson
 Cancer Center of Kansas, PA - McPherson
 Shaker R. Dakhil Ph: 316-262-4467
Louisiana
  Baton Rouge
 Hematology-Oncology Clinic
 Hana F Safah Ph: 504-988-6121
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 John T Cole Ph: 888-562-4763
 Tulane Cancer Center at Tulane University Hospital and Clinic
 Hana F Safah Ph: 504-988-6121
Michigan
  Detroit
 Wayne State University
 Sayeh M Lavasani Ph: 313-576-9363
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-4673
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Robin Zon Ph: 574-234-5123
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Robin Zon Ph: 574-234-5123
  Troy
 William Beaumont Hospital - Troy Campus
 Padmaja V Venuturumilli Ph: 248-551-7695
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Louis Park
 CCOP - Metro-Minnesota
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Joplin
 St. John's Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Montana
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 402-280-4100
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 402-280-4100
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 402-280-4100
 Creighton University Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Immanuel Medical Center
 Gamini S. Soori Ph: 402-280-4100
 Lakeside Hospital
 Gamini S. Soori Ph: 402-280-4100
New Hampshire
  Nashua
 Oncology Center at St. Joseph Hospital
 Mary Ann Voltz Ph: 603-880-3408
  Email: carcieri@sjh-nh.org
New Mexico
  Albuquerque
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Melanie E. Royce Ph: 505-727-8000
New York
  Auburn
 Hematology Oncology Associates of Central New York-Auburn
 Jeffrey J. Kirshner Ph: 315-472-7504
  Rome
 Hematology-Oncology Associates of New York - Rome
 Jeffrey J. Kirshner Ph: 315-472-7504
  Syracuse
 Hematology Oncology Associates of Central New York-Onondaga Hill
 Jeffrey J. Kirshner Ph: 315-472-7504
North Carolina
  Asheboro
 Randolph Hospital
 Peter Rubin Ph: 336-832-0821
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Peter Rubin Ph: 336-832-0821
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Hendersonville Hematology and Oncology
 James E. Radford Ph: 828-696-4716
 Park Ridge Hospital Breast Health Center
 James Dewitt Bearden Ph: 800-486-5941
  Reidsville
 Annie Penn Cancer Center
 Peter Rubin Ph: 336-832-0821
  Winston-Salem
 CCOP - Southeast Cancer Control Consortium
 Katherine D Crew Ph: 212-305-1732
  Email: kd59@columbia.edu
North Dakota
  Minot
 Trinity CancerCare Center
 Stephen N Makoni Ph: 800-862-0005
Ohio
  Columbus
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 William C Dooley Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
South Carolina
  Anderson
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
 James Dewitt Bearden Ph: 800-486-5941
  Florence
 McLeod Regional Medical Center
 Rajesh Bajaj Ph: 843-679-7256
  Greenville
 Greenville Memorial Hospital
 Jeffrey Kent Giguere Ph: 864-241-6251
  Lancaster
 Carolina Blood and Cancer Care Associates, PA
 James Dewitt Bearden Ph: 800-486-5941
Texas
  Amarillo
 Texas Tech University Health Sciences Center School of Medicine - Amarillo
 Rakhshanda L Rahman Ph: 806-354-5411
  Dallas
 Baylor University Medical Center - Dallas
 Michael D. Grant Ph: 800-422-9567
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Therese B Bevers Ph: 713-792-3245
  Laredo
 Doctor's Hospital of Laredo
 Gary W. Unzeitig Ph: 888-823-5923
  Email: ctsucontact@westat.com
Washington
  Spokane
 Rockwood Clinic Cancer Treatment Center
 Kirk A. Lund Ph: 509-755-5800
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Alison K Conlin Ph: 503-215-6412
West Virginia
  Princeton
 Princeton Community Hospital
 Rowena Gonzales-Chambers Ph: 304-487-7000
Wisconsin
  Janesville
 Mercy Regional Cancer Center
 Robert Delaune Ph: 800-928-1103
  New Richmond
 Cancer Center of Western Wisconsin
 Joseph W Leach Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01097278
ClinicalTrials.gov processed this data on April 06, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top