JPRN-UMIN000028476
Completed
Phase 3
Cohort Study to Evaluate the Efficacy and Safety of Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients - Cohort Study accompanying with N-SAS BC07/RESPECT
RESPECT executive committee0 sites300 target enrollmentAugust 1, 2017
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HER2 positive primary breast cancer in elderly
- Sponsor
- RESPECT executive committee
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs) 2\. Postoperative histological axillary lymph node metastasis \>\=4 3\. Axillary lymph node is not histologically evaluated 4\. Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site) 5\. History of drug\-related allergy which could hinder planned treatment 6\. Any history or complication of following cardiac disorders \- History of congestive heart failure, cardiac infarction \- Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease 7\. Poorly controlled hypertension (ex. Systolic arterial pressure \>\=180 mmHg or diastolic blood pressure \>\=100 mmHg) 8\. Poorly controlled diabetes 9\. Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (ADL) 10\. Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms 11\. Ineligible to the trial based on decision of an investigator
Outcomes
Primary Outcomes
Not specified
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