Adjuvant Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer

Completed

• Conditions: Adenocarcinoma of Breast; Breast Cancer

• Registration Number: NCT04829890
• Lead Sponsor: Hellenic Cooperative Oncology Group

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 followed by weekly docetaxel or weekly paclitaxel.

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 oncology. This study was a pooled analysis of two separate sequential feasibility studies who received the below described treatment. Patients who participated were 18 years old or older, women of any menopausal status who received epirubicin for 3 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3 weeks later by 9 weekly cycles with docetaxel or paclitaxel. G-CSF was given on days 2-7 of each cycle during treatment with Epirubicin and cyclophosphamide. All premenopausal patients with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. All postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5 years. RT was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size \> 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2006-04
• Study Completion: 2014-11
• Status Verified: 2021-03
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-02
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluating the feasibility profile of dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.	Up to 147 days
Number of Participants with Treatment-Related Adverse Events treated with dose dense sequential chemotherapy with Epirubicin, cyclophosphamide and weekly docetaxel or weekly paclitaxel.	Up to 147 days