Statement: Patients with cytologically confirmed breast cancer, who's Locally recurrent disease is amenable to radiation with curative intent are not eligible for the secondary trial, but are eligible for the primary trial.
Primary_evidence: Inclusion Criteria:   Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.   Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.   Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.   If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.   Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.   Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.   Subject must have adequate bone marrow, renal and hepatic function.   Subject must not be pregnant or plan to conceive a child. Exclusion Criteria:   Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.   More than 2 prior lines of cytotoxic chemotherapy.   Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.   Prior taxane therapy for metastatic breast cancer.   A history of or evidence of brain metastases or leptomeningeal disease.   A history of uncontrolled seizure disorder.   Pre-existing neuropathy from any cause in excess of Grade 1.   Known history of allergic reaction to cremophor/paclitaxel.   Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.   Pregnant or breastfeeding.
Secondary_evidence: INCLUSION CRITERIA:   Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.   Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.   No prior therapy for breast cancer within the past 5 years.   18 years of age or older.   Ability to understand and the willingness to sign a written informed consent document. 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 (eg, calcium citrate with vitamin D) within the prior 6 months.   History of renal failure requiring dialysis or kidney transplantation.   Pregnant or nursing   Receiving supplemental calcium > 1200 mg calcium per day during study.   Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.   Locally-advanced breast cancer   Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy   Plans for preoperative radiation therapy   Plans for breast cancer surgery, and does 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