Ignite Creation Date:
2024-05-05 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00793377
Status:
COMPLETED
Last Update Posted:
2008-11-19
First Post:
2008-11-17
Brief Title:
Neoadjuvant DoxorubicinCyclophosphamide Followed by Docetaxel AC-Doc Versus Dose-Dense Doxorubicin and Docetaxel ADoc in Breast Cancer
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
Official Title:
A Randomized Multicenter Open Phase III Study Comparing a Dose-Intensified 8 Week Schedule of Adriamycin and Docetaxel ADOC With a Sequential 24 Week Schedule of AdriamycinCyclophosphamide Followed by Docetaxel AC-DOC Regimen as Preoperative Therapy in Patients With Operable Carcinoma of the Breast T2-3 N0-2 M0
Status:
COMPLETED
Status Verified Date:
2008-11
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:
The primary objective of this trial is to compare the rate of pathologically complete remissions achieved using a preoperative dose-intensified 8 week therapy consisting of adriamycin and docetaxel with a preoperative sequential 24 week regimen consisting of adriamycincyclophosphamide followed by docetaxel in patients with operable carcinoma of the breast Secondary aims are to assess disease-free and overall survival the rate of complete and partial responses by palpation and imaging methods the rate of breast-conserving operations and the toxicity of the two chemotherapy regimens
Women meeting the following criteria will be eligible for the study those with operable breast cancer T2-3 N0-2 M0 with the diagnosis histologically confirmed by biopsy and measurable disease on mammography or sonography or breast MRI the most appropriate method should be chosen by the investigator After the patients have given written informed consent they will be randomly assigned to the study treatments Patients in group I will receive four cycles of combination chemotherapy consisting of adriamycin 50 mgm2 15 min iv infusion and docetaxel 75 mgm2 1 h iv infusion repeated every 14 days followed by surgery 9-10 weeks after the start of therapy Patients in group II will receive four cycles of adriamycin 60 mgm2 15 min iv and cyclophosphamide 600 mgm2 1 h iv every three weeks followed by four cycles of docetaxel 100 mgm2 1 h iv every three weeks Surgery will be performed during week 25 or 26 Patients in both groups will additionally receive oral doses of tamoxifen 20 mg once daily for 5 years starting on the first day of chemotherapy Surgery will consist of removal of the remaining tumor breast-conserving resection or mastectomy and axillary dissection Sentinel node biopsy is allowed if the patient is involved in a randomized trial Radiotherapy is applicated according to standard proceedings of participating center A second randomization for additional versus no additional postoperative chemotherapy is recommended in ypN disease Patients with disease progression during preoperative therapy chemotherapy can be stopped and surgery can be performed immediately
Women meeting the following criteria will be eligible for the study those with operable breast cancer T2-3 N0-2 M0 with the diagnosis histologically confirmed by biopsy and measurable disease on mammography or sonography or breast MRI the most appropriate method should be chosen by the investigator After the patients have given written informed consent they will be randomly assigned to the study treatments Patients in group I will receive four cycles of combination chemotherapy consisting of adriamycin 50 mgm2 15 min iv infusion and docetaxel 75 mgm2 1 h iv infusion repeated every 14 days followed by surgery 9-10 weeks after the start of therapy Patients in group II will receive four cycles of adriamycin 60 mgm2 15 min iv and cyclophosphamide 600 mgm2 1 h iv every three weeks followed by four cycles of docetaxel 100 mgm2 1 h iv every three weeks Surgery will be performed during week 25 or 26 Patients in both groups will additionally receive oral doses of tamoxifen 20 mg once daily for 5 years starting on the first day of chemotherapy Surgery will consist of removal of the remaining tumor breast-conserving resection or mastectomy and axillary dissection Sentinel node biopsy is allowed if the patient is involved in a randomized trial Radiotherapy is applicated according to standard proceedings of participating center A second randomization for additional versus no additional postoperative chemotherapy is recommended in ypN disease Patients with disease progression during preoperative therapy chemotherapy can be stopped and surgery can be performed immediately
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None