| General information |
| Database: | DB01026 |
| Objective: | Hormonal therapy plus bevacizumab in postmenopausal patients who have hormone receptorpositive metastatic breast cancer: a phase II Trial of the Sarah Cannon Oncology Research Consortium. |
| Authors: | Denise A. Yardley |
| Title: | Hormonal therapy plus bevacizumab in postmenopausal patients who have hormone receptorpositive metastatic breast cancer: a phase II Trial of the Sarah Cannon Oncology Research Consortium. |
| Journal: | clinical breast cancer |
| Year: | 2011 |
| PMID: | 21665134 |
| Trial Design |
| Clinical Trial Id: | NCT00405938 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 17 |
| Therapeutic Combination Content: | Hormonal therapy plus bevacizumab |
| Study Type: | a phase II Trial of the Sarah Cannon Oncology Research Consortium |
| Key Patients Feature: | Postmenopausal women who had hormone receptor-positive (estrogen receptor- and/or progesterone receptor-positive) metastatic breast cancer were eligible for this trial. For the purposes ofthis trial postmenopausal status required at least one of the following: 1) age more than and equal to 60 years, 2) age<60 years and amenorrhea formore than and equal to 12 months, 3) age <60 years, amenorrheic <12 months, and postmenopausal levels of follicle stimulating hormone/luteinizing hormone, 4) previous bilateral oopharectomy, or 5) previous radiation castration with amenorrhea more than and equal to 6 months. Patients could not have received any previous systemic therapy for metastatic breast cancer, including chemotherapy, hormonal therapy, or targeted therapy. Additional eligibility requirements included: measurable or evaluable disease; no history of central nervous system metastases; Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; adequate bone marrow, kidney, and liver function. Patients who were to receive trastuzumab were required to have a normal cardiac left ventricular ejection fraction. Measurement ofhuman epidermal growth factor receptor 2 status was required in all patients. Concurrent bisphosphonate therapy was permitted if it was initiated before starting study treatment. All patients were required to provide written informed consent before entering the study. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Anastrozole/ Bevacizumab vs. Fulvestrant/ Bevacizumab |
| Treatment Info: | Patients who had relapsed while receiving, or less than and equal to 12 months after receiving, adjuvant aromatase inhibitor therapy were treated with bevacizumab (10 mg/kg intravenously every 2 weeks) and fulvestrant (loading dose 500 mg intramuscularly [IM], then 250 mg IM 2 weeks later, then 250 mg IM every 4 weeks). All other patients received fulvestrant/bevacizumab or anastrozole (1 mg orally daily)/bevacizumab. Patients who were human epidermal growth factor receptor 2positive could also receive trastuzumab (8 mg/kg loading dose, then 6mg/kg every 3 weeks). |
| Primary End Point: | median PFS. |
| Secondary End Point: | the objective response rate, disease control rate, response duration, and treatmentrelated toxicity. |
| Patients Number: | 79 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median PFS was 13.5 months (95% CI 8.819.1 months). 21 months (95% CI 14 months - not reached) for anastrozole/bevacizumab and 9 months (95% CI 513 months) for fulvestrant/bevacizumab. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Only one patient had a grade 4 toxicity considered possibly related to treatment (pulmonary embolism). Grade 3 toxicities probably related to bevacizumab included hypertension (14%), proteinuria (5%), venous thromboembolism (4%), and wound dehiscence (1%). An additional 16 patients (20%) had grade 2 hypertension; 15 patients (19%) had grade 2 proteinuria. |
| Conclusions: | Bevacizumab combined with either anastrozole or fulvestrant was feasible and active in the firstline treatment of patients who have hormone receptor-positive metastatic breast cancer.phase III trials evaluating the efficacy of bevacizumab added to endocrine therapy are in progress. |