| General information |
| Database: | DB01037 |
| Objective: | Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary infl ammatory human epidermal growth factor receptor 2positive breast cancer (BEVERLY2) |
| Authors: | JeanYves Pierga |
| Title: | Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory human epidermal growth factor receptor 2positive breast cancer (BEVERLY2): an openlabel, singlearmphase 2 study. |
| Journal: | Lancet Oncology |
| Year: | 2012 |
| PMID: | 22377126 |
| Trial Design |
| Clinical Trial Id: | NCT00717405 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 13 |
| Therapeutic Combination Content: | Neoadjuvant bevacizumab, trastuzumab, and chemotherapy |
| Study Type: | phase II, multicentre, openlabel, singlearm, noncomparative trial |
| Key Patients Feature: | women (aged more than and equal to 18 years) with histologically confi rmed human epidermal growth factor receptor 2positive nonmetastatic infl ammatory breast cancer at private or public oncology centres in France. Inflammatory breast cancer was defi ned as T4d (any N), stage II (inflammation, erythema, and/or oedema localised to <50% of the breast surface), or stage III (generalised inflammation and oedema on >50% of the breast surface) by Institut GustaveRoussy classification 26 or as presence of tumour emboli in the lymph vessels of the superfi cial derma on skin biopsy sampling. Eligible patients had to have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, life expectancy of 3 months or more, human epidermal growth factor receptor 2positive tumours (assessed locally but revietheyd centrally after the last inclusion), known hormone receptor status, and no metastases. Hormone receptor positivity was defined as overexpression of 10% or more. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Before surgery, patients were treated with fl uorouracil, epirubicin, cyclophosphamide, and bevacizumab (cycles 1-4) and docetaxel, bevacizumab, and trastuzumab (cycles 5-8) in 3week cycles. After surgery, patients received adjuvant radiotherapy, trastuzumab, and bevacizumab. |
| Primary End Point: | to assesse the proportion of patients who achieved a pathological complete response (defined by central review of surgical specimens according to Sataloff classifi cation, counting missing data as failure) and adverse events in all enrolled patients. |
| Secondary End Point: | NA |
| Patients Number: | 52 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 44 (98%) of 45 assessable patients had a clinical response |
| 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 common adverse events were asthenia and nausea (both occurred in 36 [69%] of 52 patients). 25 (48%) patients had grade 3-4 neutropenia, which was the most common grade 3-4 adverse event. Only one grade 3 or worse adverse event regarded as related to bevacizumab was reported (hypertension, one patient). Four patients (8%) had cardiac failure. |
| Conclusions: | Neoadjuvant treatment with bevacizumab, trastuzumab, and chemotherapy was effi cacious and well tolerated in patients with previously untreated primary infl ammatory breast cancer. Further confi rmation of use of bevacizumab in infl ammatory breast cancer is needed. |