669 A phase III randomized trial of bendamustinehydrochloride, methotrexate, and 5-FU (BMF) versus CMF as first-line treatment of patients with metastatic breast cancer

2003 ◽  
Vol 1 (5) ◽  
pp. S201
Author(s):  
G. von Minckwitz ◽  
I. Chemozemsky ◽  
R. Souchon ◽  
N. Stuart ◽  
J. Vermorken ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Randomized Trial ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

scholarly journals Prospective Multicenter Randomized Phase III Study of Weekly versus Standard Docetaxel (D2) for First-Line Treatment of Metastatic Breast Cancer

Oncology ◽  
2010 ◽  
Vol 79 (3-4) ◽  
pp. 197-203 ◽  
Author(s):  
Hans-Joachim Stemmler ◽  
Nadia Harbeck ◽  
Isolde Gröll de Rivera ◽  
Ursula Vehling Kaiser ◽  
Gerhard Rauthe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Phase Iii Study ◽  
First Line Treatment

High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial.

1995 ◽  
Vol 13 (10) ◽  
pp. 2483-2489 ◽  
Author(s):  
W R Bezwoda ◽  
L Seymour ◽  
R D Dansey
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Randomized Trial ◽  
Metastatic Breast ◽  
High Dose ◽  
Line Treatment ◽  
First Line ◽  
Conventional Dose ◽  
Duration Of Response ◽  
First Line Treatment

PURPOSE The aims of this study were to compare in a randomized trial the results of high-dose versus conventional-dose chemotherapy as first-line treatment for metastatic breast cancer. The comparison included complete response (CR) rate, duration of response, and duration of survival. PATIENTS AND METHODS Ninety patients were entered onto a study to compare two cycles of high-dose cyclophosphamide 2.4 g/m2, mitoxantrone 35 to 45 mg/m2, and etoposide (VP16) 2.5 g/m2 (HD-CNV) versus six to eight cycles of conventional-dose cyclophosphamide 600 mg/m2, mitoxantrone 12 mg/m2, and vincristine 1.4 mg/m2 (CNV) as first-line treatment for metastatic breast cancer. The high-dose regimen included either autologous bone marrow or peripheral-blood stem-cell rescue. All 90 patients are assessable. RESULTS The response rates were significantly different. The overall response rate for HD-CNV was 43 of 45 (95%), with 23 of 45 patients (51%) achieving CR. Twenty-four of 45 patients (53%) who received conventional CNV have responded, with only two patients achieving CR. Both duration of response and duration of survival were significantly longer for patients, who received HD-CNV. Toxicity of the high-dose therapy was moderate in most patients. Grade 2 to 3 mucositis and hematologic suppression that required supportive treatment was universal, but hematologic recovery to a neutrophil count more than 500/microL and platelet count more than 40,000/microL occurred at day 18 (median) after therapy. CONCLUSION HD-CNV appears to be a promising schedule that results in a significant proportion of CRs and increased survival in patients with metastatic breast cancer.

RIBBON-1: Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Chemotherapy With or Without Bevacizumab for First-Line Treatment of Human Epidermal Growth Factor Receptor 2–Negative, Locally Recurrent or Metastatic Breast Cancer

2011 ◽  
Vol 29 (10) ◽  
pp. 1252-1260 ◽  
Author(s):  
Nicholas J. Robert ◽  
Véronique Diéras ◽  
John Glaspy ◽  
Adam M. Brufsky ◽  
Igor Bondarenko ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Objective Response ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Epidermal Growth ◽  
First Line Treatment

Purpose This phase III study compared the efficacy and safety of bevacizumab (BV) when combined with several standard chemotherapy regimens versus those regimens alone for first-line treatment of patients with human epidermal growth factor receptor 2–negative metastatic breast cancer. Patients and Methods Patients were randomly assigned in 2:1 ratio to chemotherapy plus BV or chemotherapy plus placebo. Before random assignment, investigators chose capecitabine (Cape; 2,000 mg/m2 for 14 days), taxane (Tax) -based (nab-paclitaxel 260 mg/m2, docetaxel 75 or 100 mg/m2), or anthracycline (Anthra) -based (doxorubicin or epirubicin combinations [doxorubicin/cyclophosphamide, epirubicin/cyclophosphamide, fluorouracil/epirubicin/cyclophosphamide, or fluorouracil/doxorubicin/cyclophosphamide]) chemotherapy administered every 3 weeks. BV or placebo was administered at 15 mg/kg every 3 weeks. The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), 1-year survival rate, objective response rate, duration of objective response, and safety. Two independently powered cohorts defined by the choice of chemotherapy (Cape patients or pooled Tax/Anthra patients) were analyzed in parallel. Results RIBBON-1 (Regimens in Bevacizumab for Breast Oncology) enrolled 1,237 patients (Cape cohort, n = 615; Tax/Anthra cohort, n = 622). Median PFS was longer for each BV combination (Cape cohort: increased from 5.7 months to 8.6 months; hazard ratio [HR], 0.69; 95% CI, 0.56 to 0.84; log-rank P < .001; and Tax/Anthra cohort: increased from 8.0 months to 9.2 months; HR, 0.64; 95% CI, 0.52 to 0.80; log-rank P < .001). No statistically significant differences in OS between the placebo- and BV-containing arms were observed. Safety was consistent with results of prior BV trials. Conclusion The combination of BV with Cape, Tax, or Anthra improves clinical benefit in terms of increased PFS in first-line treatment of metastatic breast cancer, with a safety profile comparable to prior phase III studies.

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