NCT04829890

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

Adjuvant Dose-dense Sequential Chemotherapy With Epirubicin, CMF, and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer: A Hellenic Cooperative Oncology Group (HeCOG) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 89 (actual)
• Sponsor: Hellenic Cooperative Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer
• Adenocarcinoma of Breast

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-04-01
• Completion: 2014-11-01
• First posted: 2021-04-02
• Last updated: 2021-04-06