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Protocol No. UW16151

Principal Investigator Burkard, Mark

Phase Pilot/Feasibility

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Pharmacodynamic biomarkers of standard anti-microtubule drugs as assessed by early tumor biopsy

Objective Chemotherapy remains a key treatment option for metastatic breast cancer. Amongst all chemotherapy options, agents such as paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, and eribulin are the most effective. Although these agents are proven effective on patients with metastatic breast cancer, only a portion of individual patients will benefit.
Your blood and tissue samples will be used in laboratory experiments to increase our understanding of what is happening in the cells when people are given chemotherapy. The results of these laboratory tests will help researchers figure out who is likely to benefit from chemotherapy with these agents and who will not. This will help physicians choose a treatment option that is better suited for each individual patient.

Treatment Treatment will be administered on an outpatient basis per discretion of the treating physician. The drug, dose, and schedule of administration will be determined by the treating physician. The first dose will be coordinated in conjunction with research staff who will schedule a research biopsy to be completed on Day 2 of the first planned chemotherapy treatment cycle.

Description Pilot/Feasibility study, pharmacodynamic biomarkers of standard anti-microtubule drugs as assessed by early tumor biopsy. Using standard of care treatment and a controlled arm

Key Eligibility
  • Men and women with histologically or cytologically demonstrated breast cancer that is deemed metastatic or incurable by the treating physician
  • Medically appropriate to treat the patient with an antimitotic agent or an intravenous control chemotherapeutic agent by IV infusion at standard doses as per the treating physician.
  • Measureable disease as determined by RECIST 1.1
  • Archived tissue is available from either primary, metastatic site or both
  • Safe and feasible to obtain a research tumor biopsy on cycle 1 day 2 with a biopsy of an accessible lesion such as liver, lung, lymph node, skin, breast, or bone.
  • No HER2+ breast cancer by standard criteria
  • Pregnant women are excluded from this study because systemic chemotherapy may cause deleterious effects to the fetus.
  • No planned treatment with hormonal therapy, or targeted oral therapy during trial enrollment

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics