| General information |
| Database: | DB01034 |
| Objective: | Combined Neoadjuvant Chemotherapy With Bevacizumab Improves Pathologic Complete Response in Patients With Hormone Receptor Negative Operable or Locally Advanced Breast Cancer |
| Authors: | Issam Makhoul |
| Title: | Combined neoadjuvant chemotherapy with bevacizumab improves pathologic complete response in patients with hormone receptor negative operable or locally advanced breast cancer. |
| Journal: | American Journal of Clinical Oncology |
| Year: | 2015 |
| PMID: | 23563210 |
| Trial Design |
| Clinical Trial Id: | NCT00203502 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Combined neoadjuvant chemotherapy with bevacizumab |
| Study Type: | A prospective singlearm, singleinstitutionphase II trial evaluate the pathologic complete response (pCR) and safety of bevacizumab (B) with chemotherapy in the neoadjuvant setting of breast cancer (BC). |
| Key Patients Feature: | Patients eligible for the study were women older than 18 years with histologically proven BC (TNM stage IIAB/IIIABC). Patients with inflammatory BC (T4d) were not eligible. |
| Biomarker: | hormone receptor negative |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received neoadjuvant docetaxel, cyclophosphamide, bevacizumab every 3 weeks for 4 cycles followed by doxorubicin every 3 weeks for 4 cycles followed by surgery. After healing, bevacizumab was given every 3 weeks for 9 cycles. Radiation therapy, trastuzumab and endocrine therapy were given as indicated. |
| Primary End Point: | pCR |
| Secondary End Point: | NA |
| Patients Number: | 39 |
| 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: | NA |
| Adverse Event(agent arm): | The most serious grade more than and equal to 3 adverse events were infection, congestive heart failure, and pulmonary embolism. |
| Conclusions: | Chemotherapy with B improved pCR in BC patients, but was associated with significant toxicity and rare but very serious complications. The improvement was more pronounced in AA patients, those with ductal carcinoma, and those with estrogen receptor progesteron receptor BC. |