Entry Detail
| General information | |
| Database: | DB01042 |
| Objective: | A pilot study of adjuvant doxorubicin and cyclophosphamide followed by paclitaxel and sorafenib in women with nodepositive or highrisk earlystage breast cancer. |
| Authors: | Spigel DR |
| Title: | A pilot study of adjuvant doxorubicin and cyclophosphamide followed by paclitaxel and sorafenib in women with nodepositive or highrisk earlystage breast cancer. |
| Journal: | Clin Adv Hematol Oncol. |
| Year: | 2011 |
| PMID: | 21558987 |
| Trial Design | |
| Clinical Trial Id: | NCT00544167 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | adjuvant doxorubicin and cyclophosphamide followed by paclitaxel and sorafenib |
| Study Type: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Key Patients Feature: | mastectomy/breastconserving surgery; axillary node assessment for stage I/II/IIIA/IIIC (T13, N3a only) breast cancer; nodepositive/highrisk nodenegative (tumor size >2 cm; hormonereceptor negative; grade 2/3; or age <35 years); Eastern Cooperative Oncology Group performance status (ECOGPS) 01; and adequate organ function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | doxorubicin (60 mg/m(2) intravenous) and cyclophosphamide (600 mg/m(2) intravenous; AC) on day 1, every 3 weeks (x 4 cycles), followed by paclitaxel 175 mg/m(2) intravenous on day 1, (every 3 weeks x 4 cycles) or 80 mg/m(2) intravenous (every week/x 12 cycles), combined with sorafenib (400 mg oral twice a week; TS) for 12 months or less. |
| Primary End Point: | The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Lifethreatening Side Effects Per CTCAE Version 3.0. |
| Secondary End Point: | NA |
| Patients Number: | 45 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | After a median followup of 21.0 months (range, 18.925.9), all patients were alive and without recurrence. |
| Adverse Event(agent arm): | Severe toxicities during sorafenib therapy were limited, including neutropenia, anorexia, arthralgia, diarrhea, and dyspnea. |
| Conclusions: | Sorafenib was generally associated with limited severe toxicity when combined with paclitaxel following AC. Hotheyver, many patients discontinued sorafenib early due to grade 12 toxicity, physicianpatient decision, and treatment compliance. Additional studies of sorafenib in breast cancer in the neoadjuvant and triplenegative settings are warranted. |