Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301548
Status:
COMPLETED
Last Update Posted:
2006-03-13
First Post:
2006-03-09
Brief Title:
Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2006-01
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 role of early timing of adjuvant chemotherapy was postulated to be particularly important for patients with endocrine non-responsive disease The role of cytotoxicity during the period of breast surgery itself and immediately after perioperative chemotherapy remained unknown We investigated in a randomized trial the role of perioperative chemotherapy in patients treated with a preoperative chemotherapy for locally advanced breast cancer and compare it to the preoperative chemotherapy without additional cytotoxic therapy during and immediately after definitive surgery Patients with T2-3 N0-2 M0 breast cancer with both estrogen receptors ER and progesterone receptors PgR expressed in less than 20 of tumor cells or with absence of progesterone receptors received up to 6 courses of primary systemic therapy with epirubicin 25 mgm2 intravenously iv on days 1 and 2 cisplatin 60 mgm2 iv on day 1 and 5-fluorouracil 200 mgm2 iv daily as continuous infusion ECF Patients achieving a partial or complete remission were randomized to continue the infusion of fluorouracil until 2 weeks after surgery perioperative treatment arm or to stop fluorouracil infusion one week before surgery on day 21 of the sixth cycle control arm
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