Vitamin D and Breast Cancer Biomarkers in Female Patients

Breast Cancer Clinical Trial

Official title:

Vitamin D and Breast Cancer Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224678
• Other study ID #: CALGB-70806
• Secondary ID: CALGB-70806CDR00
• Status: Completed
• Phase: Phase 3
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2018
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vitamin D may help prevent breast cancer.

PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in female patients.

Description:

OBJECTIVES:

Primary

• To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.

Secondary

• To explore changes in the serum biomarker IGF1 in response to one year of vitamin D or placebo supplementation in premenopausal women.

• To explore changes in cellular proliferation (atypia and Ki67) in response to one year of vitamin D or placebo supplementation in premenopausal women.

• To explore correlations between change in breast cancer biomarkers (density, IGF1, atypia, and Ki67) with each other and with change in vitamin D levels.

• To compare methods of mammographic density analysis.

• To validate a recently developed sunlight questionnaire.

OUTLINE: This is a multicenter study. Patients are stratified according to baseline vitamin D (sufficient [≥ 30 ng/mL or ≥ 75 mmol/L] vs insufficient [< 30 ng/mL or < 75 mmol/L]) and institutional random periareolar fine-needle aspiration (RPFNA) status (performs RPFNA vs does not perform RPFNA). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral placebo once daily for 12 months.

• Arm II: Patients receive oral vitamin D (2000 IU) once daily for 12 months. Tissue and blood samples are collected at baseline and at 12 months for laboratory biomarker analysis. Patients also complete questionnaires at baseline and at 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 55 Years

Eligibility

1. Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.

2. Women with breast density = 25% (scattered fibroglandular densities or greater) are eligible.

3. Prior Treatment

1. Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.

Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.

2. Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.

4. Vitamin D Use

1. Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.

2. Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.

5. Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.

6. Patients with a history of breast implants or breast reduction are not eligible.

7. Patients with two or more bone fractures in the past five years are not eligible.

8. Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.

9. Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.

10. Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.

11. Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.

12. Required initial laboratory values - Calcium < 10.5 mg/dL

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• vitamin D
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Regional Medical Center	Anniston	Alabama
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	Mountainview Medical	Berlin	Vermont
United States	National Naval Medical Center	Bethesda	Maryland
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Illinois CancerCare - Bloomington	Bloomington	Illinois
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Illinois CancerCare - Canton	Canton	Illinois
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Saint Luke's Hospital	Chesterfield	Missouri
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire
United States	Duke Cancer Institute	Durham	North Carolina
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Elkhart Clinic, LLC	Elkhart	Indiana
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Eureka Community Hospital	Eureka	Illinois
United States	Illinois CancerCare - Eureka	Eureka	Illinois
United States	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Galesburg Clinic, PC	Galesburg	Illinois
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Greenville Hospital Cancer Center	Greenville	South Carolina
United States	Bendheim Cancer Center at Greenwich Hospital	Greenwich	Connecticut
United States	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Howard Community Hospital	Kokomo	Indiana
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lakes Region General Hospital	Laconia	New Hampshire
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	St. Rita's Medical Center	Lima	Ohio
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Illinois CancerCare - Macomb	Macomb	Illinois
United States	McDonough District Hospital	Macomb	Illinois
United States	Contra Costa Regional Medical Center	Martinez	California
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana
United States	Saint Joseph Regional Medical Center	Mishawaka	Indiana
United States	Camino Medical Group - Treatment Center	Mountain View	California
United States	El Camino Hospital Cancer Center	Mountain View	California
United States	Mercy General Health Partners	Muskegon	Michigan
United States	Mount Sinai Medical Center	New York	New York
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Illinois CancerCare - Community Cancer Center	Normal	Illinois
United States	Bay Area Breast Surgeons, Incorporated	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Larry G Strieff MD Medical Corporation	Oakland	California
United States	Tom K Lee, Incorporated	Oakland	California
United States	Cancer Care Associates - Mercy Campus	Oklahoma City	Oklahoma
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	Illinois CancerCare - Pekin	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois CancerCare - Peru	Peru	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana
United States	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina
United States	Rex Cancer Center of Wakefield	Raleigh	North Carolina
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Dana-Farber/Brigham and Women's Cancer Center at South Shore	South Weymouth	Massachusetts
United States	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina
United States	Illinois CancerCare - Spring Valley	Spring Valley	Illinois
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Munson Medical Center	Traverse City	Michigan
United States	Faxton Regional Cancer Center	Utica	New York
United States	Michiana Hematology Oncology PC - La Porte	Westville	Indiana
United States	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms	To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.	12 months