Clinical trial · Interventional
Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more sensitive to the drugs. PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and to see how well it works when given together with chemotherapy in treating patients with metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| ixabepilone | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Nab-paclitaxel | ALIAS |
| paricalcitol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paricalcitol (Zemplar)
- description
- Paricalcitol (Zemplar)
- interventionNames
- Drug: docetaxel
- Drug: ixabepilone
- Drug: paclitaxel
- Drug: paclitaxel albumin-stabilized nanoparticle formulation
- Drug: paricalcitol
Primary outcomes (1)
- measure
- Clinical feasibility of therapy administration
- timeFrame
- Baseline to 8 weeks
- description
- To test the clinical/logistical feasibility of using a titrated dose of the vitamin D analog (paracalcitol or Zemplar) in combination with a taxane or ixabepilone primarily by measuring the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available