A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial.

A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial. Research Abstract Details 

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A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial. Abstract Text:

Daigo Yamamoto,Satoru Iwase,Kaoru Kitamura,Hiroki Odagiri,Chizuko Yamamoto,Yoshinori Nagumo,Daigo Yamamoto,Satoru Iwase,Kaoru Kitamura,Hiroki Odagiri,Chizuko Yamamoto,Yoshinori Nagumo,

PURPOSE: To determine the response rate and toxicity profile of trastuzumab and capecitabine in women with HER2-overexpressing advanced breast cancer. PATIENTS AND METHODS: A total of 59 patients from 6 participating centers in Japan entered onto the study of trastuzumab and capecitabine. Eighty six percent of women had received prior chemotherapy as part of adjuvant (21.4%) or metastatic treatment (48.2%), or both (16.1%), including substantial portions of patients who had previously received either CMF (7.1%), anthracyclines (28.6%), taxanes (25.0%), or both types (25.0%) of chemotherapy. RESULTS: Responses were observed in 28 of 56 patients (overall response rate, 50%). The response rate was 65.0% in patients treated with trastuzumab and capecitabine as first-line therapy for metastatic disease, and 62.5% among HER2 +3 positive patients, while high response rates were also seen in women treated with second- or third-line therapy. Patients receiving trastuzumab and capecitabine as first-line therapy had a longer TTP than did patients receiving this treatment as second- or third-line therapy (median TTP, 280 vs. 130 days, P < 0.05). Further, patients receiving trastuzumab and capecitabine as first-line therapy had longer OS than did patients receiving this treatment as second- or third-line therapy (median OS, 780 days vs. 480 weeks, P < 0.05). The treatment-related adverse events were hand-foot syndrome (30.4%), nausea (25%), diarrhea (10.7%), stomatitis (10.7%), fatigue (7.1%), and vomiting (5.4%). However, the majority were Grade 1-2 adverse events and only six patients experienced Grade 3 adverse events. Further Grade 1 cardiac toxicity was observed in one patient, while there were no cases of alopecia and treatment-related death. CONCLUSION: Trastuzumab in combination with capecitabine is highly active in women with HER2-overexpressing metastatic breast cancer and is well tolerated.

A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial. Publishing Authors By Initials

D Yamamoto,S Iwase,K Kitamura,H Odagiri,C Yamamoto,Y Nagumo,D Yamamoto,S Iwase,K Kitamura,H Odagiri,C Yamamoto,Y Nagumo,

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A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Cancer chemotherapy and pharmacology

VOLUME: 61

Page Numbers: 509-14

Journal Abbreviation: Cancer Chemother. Pharmacol.

ISSN: 0344-5704

DAY: 22

MONTH: 05

YEAR: 2007

A phase II study of trastuzumab and capecitabine for patients with HER2-overexpressing metastatic breast cancer: Japan Breast Cancer Research Network (JBCRN) 00 Trial. Information

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LANGUAGE: eng

NlmUniqueID: 7806519

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AFFILIATION: Department of Surgery, Kansai Medical University Hirakata Hospital, Hirakata, Osaka, 573-1191, Japan, yamamotd@hirakata.kmu.ac.jp.

Country: Germany

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MEDLINETA: Cancer Chemother Pharmacol

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