此項試驗之目的在於了解BMS-247550在於與已經核可之藥物capecitabine併用比得單用capecitabine是否可以達到較好的治療反應，治療之病患為對於anthracycline(小紅莓類藥物)及taxane(紫杉醇類藥物)都已經反應不佳之病患。關於此項治療之安全性亦將同時探討。

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

　

Condition	Treatment or Intervention	Phase
轉移性乳癌患者 Metastatic breast cancer	藥物代表名稱: BMS-247550	第三期人體試驗 Phase III

可進入試驗之條件：18歲以上之女性轉移性乳癌患者。

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

執行定義

Criteria

• Patients must have recieved either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy (At least one regimen given in the metastatic setting).

• Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).

• Patients must have recieved a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.

• Patients must be resistant to taxane therapy.

• Patients may not have any history of brain and/or leptomeningeal metastases.

• Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).

• Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)