Vitamin D and Breast Cancer: Does Weight Make a Difference?
Trial ID or NCT#
NCT01472445
Status
NOT RECRUITING
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?
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
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.
Investigator(s)
Robert W Carlson
Contact us to find out if this trial is right for you.
Contact
ccto-office@stanford.edu
650-498-7061
View on ClinicalTrials.gov
