Status: Closed
Activation Date: 2012JUL30
Closing Date: 2016APR20
Phase: II
Description: A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer
Eligibility: Patients with histoligical/cytological diagnosis of metastatic breast cancer, that is advanced and/or metastatic, with no curative therapy and for which systemic therapy is indicated. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. Patients must have received at least one prior chemotherapy regimen for advanced or metastatic disease, unless they have relapsed within 6 months of completion of adjuvant chemotherapy or they have received taxane and/or anthracycline containing adjuvant chemotherapy. ECOG 0-2. No neuropathy > grade 1.
Objective: Primary Objective: To evaluate the effect of reolysin in combination with standard paclitaxel chemotherapy on the progression free survival of patients with advanced or metastatic breast cancer Secondary Objectives: a) to determine the tolerability and toxicity of reolysin and paclitaxel when given in combination. b) to investigate additional potential measures of efficacy including: objective response rate, overall survival, CTC counts c) to explore potential molecular factors predictive of response by assessment of archival tumour tissue and CTCs, including EGFR and KRAS status.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to discover if adding reolysin to standard chemotherapy (paclitaxel) is as effective as standard chemotherapy (paclitaxel) alone. If patient is randomized to Arm A, they will be given reolysin by needle through a vein in their arm over 1 hour. Reolysin is given on days 1,2,8,9, 15 and 16 every 4 weeks. Paclitaxel will be given by needle into a vein over 1 hour on days 1, 8 and 15 every 4 weeks. If patient is randomized to Arm B, they will receive paclitaxel, given by needle into one of their veins over 1 hour on days 1, 8 and 15 every 4 weeks. Side-effects and safety of reolysin and paclitaxel in combination will be monitored. Additional research will investigate tissue samples from previously removed breast tissue.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I213 | 81 | 73 | 76 | 80 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I213 | 81 | 1 | 32 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I213 | 81 | 69 | 0 | 0 | 0 | 64 | 70 | 0 | 0 |