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

Tadahiko Shien, Kenichi Nakamura, Taro Shibata, Takayuki Kinoshita, Kenjiro Aogi, Tomomi Fujisawa, Norikazu Masuda, Kenichi Inoue, Haruhiko Fukuda, Hiroji Iwata

Research output: Contribution to journalArticle

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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 languageEnglish
Article numberhys120
Pages (from-to)970-973
Number of pages4
JournalJapanese Journal of Clinical Oncology
Volume42
Issue number10
DOIs
Publication statusPublished - Oct 2012

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Medical Oncology
Japan
Randomized Controlled Trials
Breast Neoplasms
Neoplasms
Survival
Therapeutics
Random Allocation
Estrogen Receptors
Patient Selection
Disease-Free Survival
Ulcer
Disease Progression
Hemorrhage
Morbidity
Recurrence
Drug Therapy

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 journalArticle

Shien, Tadahiko ; Nakamura, Kenichi ; Shibata, Taro ; Kinoshita, Takayuki ; Aogi, Kenjiro ; Fujisawa, Tomomi ; Masuda, Norikazu ; Inoue, Kenichi ; Fukuda, Haruhiko ; Iwata, Hiroji. / 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. In: Japanese Journal of Clinical Oncology. 2012 ; Vol. 42, No. 10. pp. 970-973.
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