Status: Closed
Activation Date: 2003FEB25
Closing Date: 2009JUN08
Phase: I-II
Description: A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer
Eligibility: To determine MTD and recommended phase II dose of docetaxel and epirubicin with pegfilgrastim in a phase I dose escalation study as 1st line therapy. To evaluate toxicity of the combination at the recommended phase II dose. To evaluate response rate and duration of the combination as first-line therapy at the recommended phase II dose.
Objective: Women with locally advanced or inflammatory breast cancer; no previous surgical systemic or radiation treatment for breast cancer other than biopsy for diagnosis; ECOG 0, 1, 2; adequate blood counts; LVEF > institutional lower normal limit; no history of cardiac disease.
Participation: Limited
Lay Description: The purpose of this study is to find out what effect these drugs (epirubicin and docetaxel) have on and to find a more effective treatment for this type of breast cancer. It is thought that the two drugs, epirubicin and docetaxel when given together may be effective in shrinking tumours. This study will evaluate the safety and effectiveness of docetaxel and epirubicin when they are given together.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BREAST | MA22 | 93 | 41 | 40 | 41 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| BREAST | MA22 | 93 | 3 | 40 |
| 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 |
| BREAST | MA22 | 93 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |