Breast CancerPhase 3NCT01224678

Vitamin D and Breast Cancer Biomarkers in Female Patients

A Phase 3 study testing vitamin D in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 103 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages Up to 55 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: vitamin D
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 103 sitesUnited States
Study dates: Oct 2010to Dec 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 55 years
Women only
No healthy volunteers
Child, Adult

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.
Women with breast density ≥ 25% (scattered fibroglandular densities or greater) are eligible.
Prior Treatment
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.
Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.
Vitamin D Use
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.
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.
Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.
Patients with a history of breast implants or breast reduction are not eligible.
Patients with two or more bone fractures in the past five years are not eligible.
Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.
Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.
Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.
Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.
Required initial laboratory values - Calcium < 10.5 mg/dL

Trial locations and contacts

103 sites in 1 country.

City, postcode or hospital

103 sites in 1 country

United States103 sites

Regional Medical Center
Anniston, Alabama, 36207
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017
Mountainview Medical
Berlin Corners, Vermont, 05602
National Naval Medical Center
Bethesda, Maryland, 20889-5600
Mecosta County Medical Center
Big Rapids, Michigan, 49307
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701
St. Joseph Medical Center
Bloomington, Illinois, 61701
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Illinois CancerCare - Canton
Canton, Illinois, 61520
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549
Saint Luke's Hospital
Chesterfield, Missouri, 63017
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, 03301
Duke Cancer Institute
Durham, North Carolina, 27710
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Elmhurst Hospital Center
Elmhurst, New York, 11373
Eureka Community Hospital
Eureka, Illinois, 61530
Illinois CancerCare - Eureka
Eureka, Illinois, 61530
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Galesburg Clinic, PC
Galesburg, Illinois, 61401
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, 12801
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, 29605
CCOP - Greenville
Greenville, South Carolina, 29615
Bendheim Cancer Center at Greenwich Hospital
Greenwich, Connecticut, 06830
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37662
Howard Community Hospital
Kokomo, Indiana, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Lakes Region General Hospital
Laconia, New Hampshire, 03246
Doctor's Hospital of Laredo
Laredo, Texas, 78045
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
St. Rita's Medical Center
Lima, Ohio, 45801
Lowell General Hospital
Lowell, Massachusetts, 01854
Illinois CancerCare - Macomb
Macomb, Illinois, 61455
McDonough District Hospital
Macomb, Illinois, 61455
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470
Camino Medical Group - Treatment Center
Mountain View, California, 94040
El Camino Hospital Cancer Center
Mountain View, California, 94040
Mercy General Health Partners
Muskegon, Michigan, 49444
Mount Sinai Medical Center
New York, New York, 10029
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
BroMenn Regional Medical Center
Normal, Illinois, 61761
Community Cancer Center
Normal, Illinois, 61761
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761
Bay Area Breast Surgeons, Incorporated
Oakland, California, 94609
CCOP - Bay Area Tumor Institute
Oakland, California, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, 94609
Tom K Lee, Incorporated
Oakland, California, 94609
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, 73120
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, 32803-1273
Community Hospital of Ottawa
Ottawa, Illinois, 61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350
Palo Alto Medical Foundation
Palo Alto, California, 94301
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554
Illinois CancerCare - Pekin
Pekin, Illinois, 61603
Proctor Hospital
Peoria, Illinois, 61614
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Illinois CancerCare - Peru
Peru, Illinois, 61354
Illinois Valley Community Hospital
Peru, Illinois, 61354
Study site
Pismo Beach, California, 93449
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, 27607
Rex Cancer Center of Wakefield
Raleigh, North Carolina, 27614
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085
Doctors Medical Center - San Pablo Campus
San Pablo, California, 94806
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, 29672
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, 02190
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, 29307
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, 61362
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Munson Medical Center
Traverse City, Michigan, 49684
Faxton Regional Cancer Center
Utica, New York, 13502
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Vitamin D and Breast Cancer Biomarkers

RATIONALE: Vitamin D may help prevent breast cancer.

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

Read the detailed 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.

Conditions: Breast Cancer
Being tested: vitamin D, placebo
Keywords: breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vitamin DDietary supplement
Given orally
placeboOther
Given orally

Study groups in NCT01224678
Study group	Role	What they receive
Placebo	Placebo comparator	Patients receive oral placebo once daily for 12 months. Receives: Other: placebo
Vitamin D	Experimental	Patients receive oral vitamin D (2000 IU) once daily for 12 months. Receives: Dietary Supplement: vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Dec 2014

First posted20 Oct 2010 (estimated)
Study startOct 2010
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01224678
Sponsor's protocol ID: CALGB-70806
Other IDs: CALGB-70806, CDR0000687263
Status last verified: Sep 2024
First submitted: 19 Oct 2010
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin D and Breast Cancer Biomarkers
ClinicalTrials.gov ID: NCT01224678
Acronym / sponsor ID: CALGB-70806
Conditions: Breast Cancer
Keywords: breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Alliance for Clinical Trials in OncologyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Oct 2010 (actual)
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 20 Oct 2010 (estimated)
Results: Posted 25 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Vitamin D may help prevent breast cancer.

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

Detailed 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.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: placeboPatients receive oral placebo once daily for 12 months.
Vitamin D	Experimental	Dietary Supplement: vitamin DPatients receive oral vitamin D (2000 IU) once daily for 12 months.

Who may qualify

Ages: Up to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vitamin DGiven orally	Dietary supplement	Vitamin D
placeboGiven orally	Other	Placebo

Primary outcome

Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms
Time frame: 12 months
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.

Results and safety

Results posted to the registry on 25 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	150	150
Vitamin D	150	150

Primary outcome: Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms

Time frame: 12 months. Mean (Standard Deviation). Unit: percent change

Measure	Placebo n = 46	Vitamin D n = 40
Value	-3.4 (7.1)	-1.4 (11.9)

Population analysed: 86 of the 300 patients were analyzed for the primary endpoint

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 150 (0%)	1 of 150 (0.7%)	Not reported
Vitamin D	0 of 150 (0%)	1 of 150 (0.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marie E. Wood, MD study chair

University of Vermont

103 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vitamin D in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 103 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01224678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.