Conditions: Neoplasms Breast Neoplasms Breast Cancer
Keywords: Cancer Tumour Breast cancer Metastatic Secondary
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 330
Healthy volunteers: no

Brief summary:
The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.

Detailed description:

Arms:
arm 1: AZD8931 plus Paclitaxel arm 2: Placebo plus Paclitaxel

Interventions: intervention 1: AZD8931 intervention 2: Paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Tablet Oral bid intervention 2: IV once weekly for 3 weeks followed by a week off (repeated cycles) intervention 3: Oral bid (twice daily)

Protocol document: