Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129896
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2005-08-11
Brief Title:
Neoadjuvant Chemotherapy With MyocetTaxotereHerceptin for HER2 Positive Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Open-label Phase I-II Clinical Trial to Evaluate Treatment With MyocetTaxotereHerceptin as Primary Chemotherapy Treatment for HER2neu Positive Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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 is an open-label study to assess the efficacy and tolerability of the combination MyocetTaxotereHerceptin as primary treatment for HER2 positive breast cancer patients HER2 status will be confirmed centrally by fluorescence in situ hybridization FISH
Phase I Initial doses will be
Myocet 50-60 mgm² day 1 every 3 weeks Taxotere 60-75 mgm² day 1 every 3 weeks and Herceptin 4 2 mgkg weekly
Sample size will depend on the number of patients recruited during dose escalation Three patients must be recruited in each dose level If one out of three experiences a dose-limiting toxicity DLT 3 more patients must be recruited in the same dose level Considering that there are 4 dose levels to be tested the estimated number of patients is 9 to 24 Patients receiving the recommended dose RD will be incorporated into phase II of the study
Phase I Initial doses will be
Myocet 50-60 mgm² day 1 every 3 weeks Taxotere 60-75 mgm² day 1 every 3 weeks and Herceptin 4 2 mgkg weekly
Sample size will depend on the number of patients recruited during dose escalation Three patients must be recruited in each dose level If one out of three experiences a dose-limiting toxicity DLT 3 more patients must be recruited in the same dose level Considering that there are 4 dose levels to be tested the estimated number of patients is 9 to 24 Patients receiving the recommended dose RD will be incorporated into phase II of the study
Detailed Description:
Phase II The average pathological complete response rate reported in other trials is around 11 The investigators expect to achieve an increase of 14 on this rate that is they expect a pathological response rate of 25 With a 005 and β02 18 patients are initially needed If at least 3 pathological complete responses are achieved recruitment will continue to up to 53 patients At least 10 pathological complete responses are needed to probe the hypothesis Considering a 10 post-randomization drop-out rate a total of 59 patients must be recruited for the trial
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