Conditions: Breast Neoplasms
Keywords: breast neoplasm breast cancer breast tumor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 104
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

Detailed description:
The primary objective is to determine the response rate (RR) to E7389 monotherapy administered as an IV bolus of 1.4 mg/m\^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with chemotherapy including an anthracycline and a taxane, with previously documented progression during or within six months following the last dose of prior chemotherapy.

The secondary objectives are to evaluate:

* The safety and tolerability of E7389 monotherapy in this patient population;
* The antitumor activity of E7389 as determined by duration of response, time to progression, and overall survival;
* Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire/tumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale (VAS), analgesics consumption, weight changes and performance status (PS);
* Tumor pharmacogenetics and their possible relationship to response (assessment of beta-tubulin isotype mRNA on biopsy sample) in patients who have signed a separate consent form

Arms:
arm 1: None

Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: The first cohort of subjects were to receive E7389 1.4 mg/m\^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m\^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.

Protocol document: