Abstract
This trial is being conducted to confirm the superiority, in terms of overall survival, of primary tumour resection plus systemic therapy to systemic therapy alone in patients with Stage IV breast cancer who are not refractory to primary systemic therapy. The inclusion criteria for the study are as follows: untreated patients with histologically confirmed invasive breast cancer with one or more measurable metastatic lesions diagnosed by radiological examination. All patients receive primary systemic therapy according to the estrogen receptor and human epidermal growth factor receptor type-2 status of the primary breast cancer after the first registration. After 3 months, the patients without disease progression are randomized to the primary tumour resection plus systemic therapy arm or the systemic therapy alone arm. The primary endpoint is the overall survival, and the secondary endpoints are proportion of patients without tumour progression at the metastatic sites, yearly local recurrence-free survival, proportion of local ulcer/local bleeding, yearly primary tumour resection-free survival, adverse events of chemotherapy, operative morbidity and serious adverse events. The patient recruitment was commenced in May 2011. Enrolment of 410 patients for randomization is planned over a 5 year recruitment period. We hereby report the details of the study.
| Original language | English |
|---|---|
| Article number | hys120 |
| Pages (from-to) | 970-973 |
| Number of pages | 4 |
| Journal | Japanese Journal of Clinical Oncology |
| Volume | 42 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Oct 2012 |
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Keywords
- Breast medicine
- Breast-basic
- Metastasis
- Surgery
ASJC Scopus subject areas
- Oncology
- Cancer Research
- Radiology Nuclear Medicine and imaging
Cite this
A randomized controlled trial comparing primary tumour resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (PRIM-BC) : Japan Clinical Oncology Group Study JCOG1017. / Shien, Tadahiko; Nakamura, Kenichi; Shibata, Taro; Kinoshita, Takayuki; Aogi, Kenjiro; Fujisawa, Tomomi; Masuda, Norikazu; Inoue, Kenichi; Fukuda, Haruhiko; Iwata, Hiroji.
In: Japanese Journal of Clinical Oncology, Vol. 42, No. 10, hys120, 10.2012, p. 970-973.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized controlled trial comparing primary tumour resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (PRIM-BC)
T2 - Japan Clinical Oncology Group Study JCOG1017
AU - Shien, Tadahiko
AU - Nakamura, Kenichi
AU - Shibata, Taro
AU - Kinoshita, Takayuki
AU - Aogi, Kenjiro
AU - Fujisawa, Tomomi
AU - Masuda, Norikazu
AU - Inoue, Kenichi
AU - Fukuda, Haruhiko
AU - Iwata, Hiroji
PY - 2012/10
Y1 - 2012/10
N2 - This trial is being conducted to confirm the superiority, in terms of overall survival, of primary tumour resection plus systemic therapy to systemic therapy alone in patients with Stage IV breast cancer who are not refractory to primary systemic therapy. The inclusion criteria for the study are as follows: untreated patients with histologically confirmed invasive breast cancer with one or more measurable metastatic lesions diagnosed by radiological examination. All patients receive primary systemic therapy according to the estrogen receptor and human epidermal growth factor receptor type-2 status of the primary breast cancer after the first registration. After 3 months, the patients without disease progression are randomized to the primary tumour resection plus systemic therapy arm or the systemic therapy alone arm. The primary endpoint is the overall survival, and the secondary endpoints are proportion of patients without tumour progression at the metastatic sites, yearly local recurrence-free survival, proportion of local ulcer/local bleeding, yearly primary tumour resection-free survival, adverse events of chemotherapy, operative morbidity and serious adverse events. The patient recruitment was commenced in May 2011. Enrolment of 410 patients for randomization is planned over a 5 year recruitment period. We hereby report the details of the study.
AB - This trial is being conducted to confirm the superiority, in terms of overall survival, of primary tumour resection plus systemic therapy to systemic therapy alone in patients with Stage IV breast cancer who are not refractory to primary systemic therapy. The inclusion criteria for the study are as follows: untreated patients with histologically confirmed invasive breast cancer with one or more measurable metastatic lesions diagnosed by radiological examination. All patients receive primary systemic therapy according to the estrogen receptor and human epidermal growth factor receptor type-2 status of the primary breast cancer after the first registration. After 3 months, the patients without disease progression are randomized to the primary tumour resection plus systemic therapy arm or the systemic therapy alone arm. The primary endpoint is the overall survival, and the secondary endpoints are proportion of patients without tumour progression at the metastatic sites, yearly local recurrence-free survival, proportion of local ulcer/local bleeding, yearly primary tumour resection-free survival, adverse events of chemotherapy, operative morbidity and serious adverse events. The patient recruitment was commenced in May 2011. Enrolment of 410 patients for randomization is planned over a 5 year recruitment period. We hereby report the details of the study.
KW - Breast medicine
KW - Breast-basic
KW - Metastasis
KW - Surgery
UR - http://www.scopus.com/inward/record.url?scp=84866756749&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84866756749&partnerID=8YFLogxK
U2 - 10.1093/jjco/hys120
DO - 10.1093/jjco/hys120
M3 - Article
C2 - 22833684
AN - SCOPUS:84866756749
VL - 42
SP - 970
EP - 973
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
SN - 0368-2811
IS - 10
M1 - hys120
ER -