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Vitamin D and Breast Cancer: Does Weight Make a Difference?
Not Recruiting
Trial ID: NCT01472445
Purpose
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.
Official Title
Vitamin D and Breast Cancer: Does Weight Make a Difference?
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Intervention(s):
drug: Vitamin D
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
ccto-office@stanford.edu
650-498-7061