title: 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.
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.
authors: Department of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan. tshien@md.okayama-u.ac.jp
authors: Tadahiko
authors: T
authors: Shien
authors: Kenichi
authors: K
authors: Nakamura
authors: Taro
authors: T
authors: Shibata
authors: Takayuki
authors: T
authors: Kinoshita
authors: Kenjiro
authors: K
authors: Aogi
authors: Tomomi
authors: T
authors: Fujisawa
authors: Norikazu
authors: N
authors: Masuda
authors: Kenichi
authors: K
authors: Inoue
authors: Haruhiko
authors: H
authors: Fukuda
authors: Hiroji
authors: H
authors: Iwata
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077289:Letrozole; D008408:Mastectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D009570:Nitriles / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage; D000068878:Trastuzumab; D014230:Triazoles / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D000077289:Letrozole; D000068878:Trastuzumab; D017239:Paclitaxel