Conditions: Metastatic Breast Cancer
Keywords: breast
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
Primary Objectives

* Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy
* Detailed characterization of peripheral neuropathy in patients who receive ixabepilone

Secondary Objectives

* Clinical benefit rate
* Time to progression ( TTP)
* Toxicity
* Exploratory studies:

  * Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons.
  * Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.

Detailed description:
Eligible patient population:

* Stage 4 breast cancer
* Resolution from toxicity of prior therapy to ≤ CTC grade 1 ( except alopecia)
* No limit on prior number of therapies to treat cancer
* Adequate organ function
* Life expectancy greater than 3 months

Treatment: ixabepilone 40 mg/m2 Q3w over 3 hours

Evaluation on Study:

I. Efficacy evaluation:

* Baseline CT chest, abdomen and pelvis and bone scan within 4 weeks of starting therapy
* Evaluation of disease every 2 cycles of chemotherapy
* Ongoing toxicity evaluation using NCI CTC 3.

II. Neurological evaluation:

* Detailed neurologic exam using Neuropathy Assessment Instrument (represents a standard neurological exam)
* Serum NGF, IL 8,10, prior to starting therapy and prior to each cycle of ixabepilone
* DNA for assessment of TRK A and MDR1 polymorphisms
* Punch biopsy of skin prior to starting therapy and after every 2 cycles. Laboratory evaluation of peripheral nerve biopsies will be conducted at Rockefeller University under the direction of Dr. Carlson in Dr. Strickland's Lab.

Arms:
arm 1: Participants are treated with Ixabepilone. arm 2: None

Interventions: intervention 1: ixabepilone
Intervention descriptions: intervention 1: ixabepilone 40 mg/m2 Q3w over 3 hours

Protocol document: