Vitamin D and Breast Cancer: Does Weight Make a Difference? (NCT01472445) | Clinical Trial Compass
TerminatedPhase 2
Vitamin D and Breast Cancer: Does Weight Make a Difference?
Stopped: Slow accrual
United States41 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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…
What they're measuring
1
Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene