A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (JCOG1017, PRIM-BC).

Phase 3

• Conditions: Metastatic breast cancer

• Registration Number: JPRN-UMIN000005586
• Lead Sponsor: Japan Clinical Oncology Group (JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-11
• Last Update Posted: 17 October 2023
• Study Completion: 2025-05-11

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

First registration (no exclusion criteria at second registration) 1. Simultaneous or metachronous (within 5 years) double cancers. 2. Infectius disease to be treated. 3. Body temperature of 38C or higher. 4. Women during pregnancy or breast-feeding. 5. Psychiatric diseases. 6. Systemic and continuous steroids medication. 7. Comorbid unstable angina pectoris or history of myocardial infarction within 6 months. 8. Uncotrollable hypertension. 9. Diabetes mellitus uncontrollable or treated by continuous insulin administration .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Proportion of patients without progression in metastatic sites, yearly local recurrence-free survival, incidence of local ulcer/local bleeding, yearly primary tumor resection-free survival, adverse events of chemotherapy, operative morbidity, serious adverse events.