Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829890
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2021-03-29
Brief Title:
Adjuvant Chemotherapy With Epirubicin CMF and Weekly Docetaxel or Weekly Paclitaxel in Patients With Resected High-risk Breast Cancer
Sponsor:
Hellenic Cooperative Oncology Group
Organization:
Hellenic Cooperative Oncology Group
Study Overview
Official Title:
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
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 po 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None