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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Inclusion Criteria:

- 3.1.1 Women who have undergone a core needle biopsy demonstrating an operable breast
cancer whom have not yet had any further therapy.

- 3.1.2 No prior therapy for breast cancer.

- 3.1.4 Age 18 years or older.

- 3.1.5 Any menopausal status

- 3.1.6 Planned surgical resection of breast cancer or repeat core biopsy tissue
sampling prior to initiation of neoadjuvant systemic chemotherapy.

- 3.1.7 Availability of tissue blocks from initial core needle biopsy.

- 3.1.8 Signed informed consent.

- 3.1.9 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.

Exclusion Criteria:

- 3.2.1 Presence of any Metastatic lesion.

- 3.2.2 History of parathyroid disease, hypercalcemia, or kidney stones.

- 3.2.3 History of SERM or aromatase inhibitor therapy.

- 3.2.4 Taking metformin.

- 3.2.5 History of renal failure requiring dialysis or kidney transplantation.

- 3.2.6 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.)

- 3.2.7 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

- 3.2.8 Patients with locally advanced breast cancer.

- 3.2.9 Any condition potentially interfering with subjects ability to comply with
taking study medication.

- 3.2.10 Any medical condition that would potentially interfere with vitamin D

- 3.2.11 Current participation in another research study that would increase risk to
subject, in the opinion of the investigators.

- 3.2.12 Patients currently taking more than 2000 IU of Vitamin D.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Outcome Measure:

Measurement of gene expression at the mRNA (Messenger Ribonucleic acid) level using PCR (polymerase chain reaction) arrays

Outcome Time Frame:

30 months

Safety Issue:


Principal Investigator

Melinda Telli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Vitamin D
  • Obesity
  • Breast Neoplasms



Stanford University Cancer Institute Stanford, California  94305