Vitamin D and Breast Cancer Biomarkers in Female Patients

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01224678
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2017-03-06
• Results First Submitted QC: 2018-06-20
• Results First Posted: 2018-06-25
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-23
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (102)

Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Contra Costa Regional Medical Center; 🇺🇸 Martinez, California, United States

Camino Medical Group - Treatment Center; 🇺🇸 Mountain View, California, United States

El Camino Hospital Cancer Center; 🇺🇸 Mountain View, California, 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

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States

Doctors Medical Center - San Pablo Campus; 🇺🇸 San Pablo, California, United States

Scroll for more (92 remaining)