Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Sorafenib Nexavar Ixabepilone Ixempra
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 83
Healthy volunteers: no

Brief summary:
In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC.

This trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.

Detailed description:

Arms:
arm 1: Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m\^2) arm 2: Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m\^2) arm 3: Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m\^2)

Interventions: intervention 1: Sorafenib intervention 2: Ixabepilone
Intervention descriptions: intervention 1: Dose Level 1 - Sorafenib PO BID (200mg) Dose Level -1 - Sorafenib PO BID (200mg) Dose Level 1a - Sorafenib PO BID (400mg) intervention 2: Dose Level 1 - Ixabepilone IV every 21 days (40mg/m\^2) Dose Level -1 - Ixabepilone IV every 21 days (32mg/m\^2) Dose Level 1a - Ixabepilone IV every 21 days (32mg/m\^2)

Protocol document: