A phase III randomized study of capecitabine as adjuvant chemotherapy versus observation in breast cancer with pathologic residual tumors after preoperative chemotherapy(JBCRG-04)
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000000843
- Lead Sponsor
- JBCRG (Japan Breast Cancer Research Group) KBCS(Korean Breast Cancer Society) KCSG(Korean Cancer Study Group)
- Brief Summary
RESULTS: DFS was longer in the capecitabine group than in the control group (74.1% vs. 67.6%). OS was longer in the capecitabine group than in the control group (89.2% vs. 83.6%). CONCLUSIONS: After standard neoadjuvant chemotherapy, the addition of adjuvant capecitabine therapy was safe and effective in prolonging DFS and OS among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 910
Not provided
1. The patient is considered to require postoperative chemotherapy other than capecitabine. 2. The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable). 3. The patient has either simultaneous or non-simultaneous bilateral breast cancer. 4. The Patients has or has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible. 5. The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding. 6. The patient has previously had an organ transplant. 7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane. 8. The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months. 9. The patient has a fever, and there is the possibility that she has an infection. 10. The patient has been shown to have metastasis to other organs. 11. The patient requires treatment for epilepsy and/or central nervous system disorders. 12. The patient is currently being treated for, or has a history of, psychiatric disease. 13. It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome. 14. For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival
- Secondary Outcome Measures
Name Time Method Overall survival, safety, cost-effectiveness, Time to recurrence, time to death