Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer

Inclusion Criteria

• Histologically confirmed invasive breast cancer

  • Metastatic or recurrent disease
  • Patients with bone metastasis only are eligible and evaluable for time to progression
• Candidate for taxane or ixabepilone therapy
• At least one lesion that can be measured in at least one diameter ≥ 2 cm by CT scan
• No symptomatic brain metastases or other symptomatic CNS metastases
• ECOG performance status 0 or 1
• Life expectancy > 3 months
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 2.0 g/dL
• Albumin corrected serum calcium < 10.5 mg/dL
• Fertile patients must use effective contraception during and for at least 1 year after study participation
• At least 2 weeks since prior chemotherapy or radiation therapy
• Prior and concurrent taxane or ixabepilone therapy allowed
• Concurrent oral multivitamins allowed (i.e., Centrum or One a Day)
• Concurrent bisphosphonates allowed

Exclusion Criteria

• History of allergy to calcitriol, paricalcitol, or other Vitamin D compounds
• History of drug or alcohol abuse within the past 6 months
• History of other malignancy except inactive nonmelanoma skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or other cancer if the patient has been disease-free for 5 or more years
• Serious medical illness that would limit survival to < 3 months
• Active, uncontrolled bacterial, viral or fungal infection
• Poorly controlled diabetes
• Concurrent supplemental calcium
• Concurrent digitalis compounds
• Concurrent chemotherapy
• Concurrent biologic therapy, including trastuzumab and bevacizumab
• Concurrent hormonal agents for breast cancer except luteinizing hormone-releasing hormone agonists