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

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melinda Telli
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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.