Status:
COMPLETED
Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer
Lead Sponsor:
Hellenic Cooperative Oncology Group
Conditions:
Breast Cancer
Adenocarcinoma of Breast
Eligibility:
FEMALE
18+ years
Brief Summary
This study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide fo...
Detailed Description
This was a transnational analysis of biological material from patients with resected high risk breast cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG) affiliated departments of on...
Eligibility Criteria
Inclusion
- Histology-confirmed epithelial cancer of the mammary gland.
- Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 M0) or high-risk N0 patients. A N0 patient is considered "high-risk" if she fulfills at least one of the following criteria; T\>= 2cm, Estrogen Receptor (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3.
- White Blood Cell count (WBC) \> 4 x 109 / l, platelets \> 100 x 109 / l.
- Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.
- Performance status (WHO) 0 or 1.
- Age \>=18 years
- Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin of 2 cm or more and the results of the axillary node dissection available.
- No evidence of significant cardiac disease
Exclusion
- History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP\> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multigated acquisition (MUGA) scan or echocardiogram.
- No previous antitumor chemotherapy or radiation
- Time from surgery 2 to 4 weeks
Key Trial Info
Start Date :
February 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04829890
Start Date
February 1 2004
End Date
November 1 2014
Last Update
April 6 2021
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