Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425516
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2007-01-22
Brief Title:
Breast Cancer Treated by Neoadjuvant Chemotherapy
Sponsor:
Centre Jean Perrin
Organization:
Centre Jean Perrin
Study Overview
Official Title:
Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response
Status:
COMPLETED
Status Verified Date:
2007-02
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:
Neoadjuvant chemotherapy known as first or induction chemotherapy in the therapeutic assumption of breast cancer is based on the narrow dependence preclinically revealed between primary tumour tumoral angiogenesis and growth of distant metastases
The results of the Aberdeen Group Smith et al 2002 Hutcheon et al 2003 of the NSABP B27 trial Bear et al 2003 and of the Gepar-Duo Group Von Minckwitz et al 2002 have shown that a sequential protocol using docetaxel after an anthracycline-based combination allowed a better clinical response leading to more frequent conservative surgeries and more importantly to an increase in the rate of complete pathological response assessing a better efficacy
The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and the same chemotherapy given as an induction treatment Even keeping the principle of a sequential treatment a crucial question is to know if this sequential treatment should be the same for all patients or if the oncologist could get a better complete pathological response disease-free or overall survival rates by an adaptation of treatment to the objective result beginning after 2 FEC 100 courses by modulation of the following courses
We will use as a primary regimen 3 FEC cycles 3 TAXOTERE cycles a standard adjuvant regimen noted in the Temporary Protocol of Treatment of the Inca page 5 October 2005 as well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy Oncologie -- volume 7 - N5 August 2005 p 370 This standard treatment will be compared to the same chemotherapy modulated in its repartition according to results obtained by subsequent tumor evaluations during induction therapy
The results of the Aberdeen Group Smith et al 2002 Hutcheon et al 2003 of the NSABP B27 trial Bear et al 2003 and of the Gepar-Duo Group Von Minckwitz et al 2002 have shown that a sequential protocol using docetaxel after an anthracycline-based combination allowed a better clinical response leading to more frequent conservative surgeries and more importantly to an increase in the rate of complete pathological response assessing a better efficacy
The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and the same chemotherapy given as an induction treatment Even keeping the principle of a sequential treatment a crucial question is to know if this sequential treatment should be the same for all patients or if the oncologist could get a better complete pathological response disease-free or overall survival rates by an adaptation of treatment to the objective result beginning after 2 FEC 100 courses by modulation of the following courses
We will use as a primary regimen 3 FEC cycles 3 TAXOTERE cycles a standard adjuvant regimen noted in the Temporary Protocol of Treatment of the Inca page 5 October 2005 as well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy Oncologie -- volume 7 - N5 August 2005 p 370 This standard treatment will be compared to the same chemotherapy modulated in its repartition according to results obtained by subsequent tumor evaluations during induction therapy
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