Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)

Phase 2

• Conditions: Breast cancer

• Registration Number: JPRN-UMIN000001582
• Lead Sponsor: Kyushu Breast Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-17
• Study Completion: 2015-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

1.History of bilateral breast cancer 2.History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 3.Inflammatory breast cancer 4.Male 5.A history of hypersensitivity reaction to any drugs. 6.Uncontrolled medical conditions. 7.Suspected of infection with fever 8.Severe peripheral neuropathy (>grade 1) 9.Symptomatic varicella. 10.HBs antigen positive 11.Treatment required pleural or pericardial effusions 12.Severe peripheral edema (>grade 1) 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.Patients who are required concurrent treatment by corticosteroids except for premedication 15.Severe psychiatric disorders 16.Pregnant or lactation women, or women with suspected pregnancy 17.Patients judged by the investigator to be unfit to be enrolled into the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
completion rate

Secondary Outcome Measures

Name	Time	Method
safety, disease-free survival