Vitamin D and Breast Cancer: Does Weight Make a Difference?

NCT01472445 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-21034SU-09262011-8486BRSADJ0024
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight.

Conditions

Breast Cancer

Keywords

Vitamin D; Obesity

Outcome Measures

Primary Outcomes (1)

• Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene

  To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non-obese subjects diagnosed with breast cancer. IGFBP-3 is an endocrine factors. Insulin-like growth factor-binding protein 3 (IGFBP-3) gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and \> 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect.

  up to 6 weeks

Secondary Outcomes (2)

• Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene

  up to 6 weeks

• Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene

  up to 6 weeks

Other Outcomes (6)

• Expression Level of MKI67 Gene

  up to 6 weeks

• Expression Level of ESR1 Gene

  up to 6 weeks

• Leptin to Adiponectin Ratio (Leptin:Adiponectin) in Blood

  up to 6 weeks

Study Arms (2)

Non-obese (Body Mass Index ≤ 25)

EXPERIMENTAL

Non-obese participants receive Vitamin D at 400 or 10,000 IU/day

Drug: Vitamin D

Obese (Body Mass Index > 25)

EXPERIMENTAL

Obese participants receive Vitamin D at 400 or 10,000 IU/day

Drug: Vitamin D

Interventions

Vitamin D DRUG

Also known as: cholecalciferol

Non-obese (Body Mass Index ≤ 25); Obese (Body Mass Index > 25)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy.
• No prior therapy for breast cancer.
• Age 18 years or older.
• Any menopausal status
• Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy.
• Availability of tissue blocks from initial core needle biopsy.
• Signed informed consent.
• Willing to discontinue use of all supplements containing Vitamin D for the duration of the study, and take only the Vitamin D provided by the study.

You may not qualify if:

• Presence of any Metastatic lesion.
• History of parathyroid disease, hypercalcemia, or kidney stones.
• History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor therapy.
• Receiving metformin.
• History of renal failure requiring dialysis or kidney transplantation.
• Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
• Patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin D intervention
• Any condition potentially interfering with subjects ability to comply with taking study medication.
• Any medical condition that would potentially interfere with vitamin D absorption.
• Current participation in another research study that would increase risk to subject, in the opinion of the investigators.
• Patients currently taking more than 2000 IU of Vitamin D.

Sponsors & Collaborators

• Melinda Telli: lead

Study Sites (1)

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Melinda Telli, Associate Professor of Medicine (Oncology)
• Organization: Stanford University

mtelli@stanford.edu

650-724-9533

Study Officials

• Melinda Telli, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: April 23, 2026
• Results First Posted: April 19, 2019

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)