Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer
Recruitment status was: Recruiting
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving combination chemotherapy together with or without bevacizumab is more effective in treating patients with nonmetastatic breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy works compared with giving combination chemotherapy together with bevacizumab in treating patients with nonmetastatic breast cancer.
Drug: epirubicin hydrochloride
Procedure: assessment of therapy complications
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ARTemis - Avastin Randomized Trial With Neo-Adjuvant Chemotherapy for Patients With Early Breast Cancer|
- Complete pathological response rates (tumor and lymph nodes) [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Pathological complete response rate in breast alone [ Designated as safety issue: No ]
- Radiological response after 3 and 6 courses of chemotherapy [ Designated as safety issue: No ]
- Rate of breast conservation [ Designated as safety issue: No ]
- Toxicities, including cardiac safety and surgical complications (wound healing, bleeding, and thrombosis) [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
- To compare the efficacy of neoadjuvant therapy comprising docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide with versus without bevacizumab in patients with HER2-negative nonmetastatic breast cancer.
- To assess quality of life of female patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 50 years old vs > 50 years old), estrogen receptor status (negative [Allred score 0-2] vs weakly positive [Allred score 3-5] vs strongly positive [Allred score 6-8]), total tumor size* (≤ 50 mm vs > 50 mm), clinical involvement of axillary nodes (yes vs no), and inflammatory/locally advanced disease (T4) (yes vs no). Patients are randomized to 1 of 2 treatment arms.
NOTE: *In cases with multifocal disease in one breast, or bilateral disease, the size to be used for the stratification is the sum of the single largest diameter of all measurable tumors.
- Arm I: Patients receive docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1 (FEC). Treatment with fluorouracil, epirubicin hydrochloride, and cyclophosphamide repeats every 3 weeks for 3 courses.
- Arm II: Patients receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive FEC as in arm I. Treatment with FEC repeats every 3 weeks for 3 courses. Patients also receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1 in FEC course 1 only.
Within 3-6 weeks after completion of last dose of study therapy, patients in both arms undergo surgery. Within 4-8 weeks after surgery, patients undergo radiotherapy according to standard protocol.
Women complete quality-of-life questionnaires (FACT-B and EuroQoL) at baseline and during and after completion of study treatment.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093235
|Cambridge, England, United Kingdom, CB2 2QQ|
|Principal Investigator:||Helena Earl, MBBS, PhD, FRCP||Cambridge University Hospitals NHS Foundation Trust|