Capecitabine with/without vinorelbine after sequential dose-dense epirubicin and paclitaxel in high-risk early breast cancer

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of the breast

• Registration Number: ISRCTN38983527
• Lead Sponsor: AGO Breast Study Group (Arbeitsgeinschaft für Gynäkolgische Onkologie) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Aged 18 to 65 years, female
2. Histologically confirmed stage II/IIIA breast cancer with four or more positive axillary lymph nodes
3. Had undergone surgery (complete surgical resection [R0] of breast tumour and axilla) before inclusion in the study
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Left ventricular ejection fraction within the normal institutional range
6. Adequate haematological, renal and hepatic function
7. Provided written informed consent

Exclusion Criteria

1. Inflammatory breast cancer
2. Received neoadjuvant endocrine therapy, chemotherapy or radiotherapy
3. Known dihydropyrimidine dehydrogenase deficiency
4. Creatinine clearance less than 30 mL/min
5. Impaired organ function
6. Metastatic disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity, assessed during treatment

Secondary Outcome Measures

Name	Time	Method
1. Disease free survivial at 3 years<br>2. Overall survival at 3 years