David Feldman
Development of Vitamin D as a Therapy for Breast Cancer - Phase II
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Vitamin D
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Women undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. Women who have undergone a core needle biopsy demonstrating breast cancer who have not yet had any further therapy are also eligible so long as their core needle biopsy is available for analysis.
- No prior therapy for breast cancer.
- Age 18 years or older.
- Ability to understand and the willingness to sign a written informed consent document.
-Signed informed consent
Key Exclusion Criteria:
-History of parathyroid disease, hypercalcemia, or kidney stones.
- Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (e.g. calcium citrate with vitamin D) within the prior 6 months.
- 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.)
- Supplemental calcium greater than 600 mg calcium per day during study.
- Patients for who initial treatment of their breast cancer will not be with breast conserving surgery or mastectomy.
- Patients with locally advanced breast cancer
- Patients planned for neoadjuvant
chemotherapy, hormonal therapy, or other systemic therapy.
- Patients planned for preoperative radiation therapy.
- Patients with planned surgical therapy of their breast cancer that would not allow for at least 10 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, such as celiac sprue, ulcerative colitis.
- Current participation in another research study that would increase risk to subject, in the opinion of the investigators
Additional Study Details
Official Title:
Development of Vitamin D as a Therapy for Breast Cancer - Phase IIAnticipated start date:
4/15/2008Lead Sponsor:
Stanford UniversityCollaborator(s):
- Department of Defense
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Gene expression profile in BCa specimens post Vit D Rx to see if profile is modified by Vit D Rx
- Gene expression profile in BCa specimens post Vit D Rx to see if profile is modified by Vit D Rx
Total Number to be Enrolled:
250Total Number to be Enrolled at Stanford:
250More Information
Secondary ID(s):
- 98671
- BRSNSTU0026
- NCT00656019
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/4/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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