Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

208

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach

1 country

360 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.8 years study duration

First Submitted

Initial submission to the registry

March 31, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed

1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed

Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

5.8 years

First QC Date

March 31, 2010

Last Update Submit

November 21, 2017

Conditions

brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer

Keywords

breast cancerductal breast carcinoma in situlobular breast carcinoma in situBRCA1 mutation carrierBRCA2 mutation carrier

Outcome Measures

Primary Outcomes (1)

Change in mammographic density at 12 months compared to baseline
12 months

Secondary Outcomes (1)

Ki-67 as assessed in tissue obtained in breast biopsies at baseline and at 12 months
12 months

Study Arms (2)

Arm I

EXPERIMENTAL

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.

Dietary Supplement: cholecalciferol

Arm II

ACTIVE COMPARATOR

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.

Dietary Supplement: cholecalciferolOther: placebo

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Given orally

Arm IArm II

placeboOTHER

Given orally

Arm II

Eligibility Criteria

Age18 Years - 50 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (360)

Northeast Alabama Regional Medical Center

Anniston, Alabama, 36202, United States

Location

Providence Hospital

Mobile, Alabama, 36608, United States

Location

Alaska Breast Care and Surgery LLC