Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196872
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2005-09-12
Brief Title:
A Study to Compare ETC vs EC-TX and Ibandronate vs Observation in Patients With Node-positive Primary Breast Cancer GAIN
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
Official Title:
A Phase III Trial to Compare ETC vs EC-TX and Ibandronate vs Observation in Patients With Node-positive Primary Breast Cancer GAIN
Status:
COMPLETED
Status Verified Date:
2012-08
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:
In the recent AGO-study a dose-dense and dose-intensified sequence of Epirubicin - Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed sequence of Epirubicin Cyclophosphamid and Paclitaxel and was therefore chosen as standard treatment in this study
The experimental arm of EC-TX combines several strategies the combination of EC will be administered every 2 weeks as a dose-dense regimen the combination of TX can also be considered as dose-dense due to the weekly application of paclitaxel Furthermore there is clinical evidence that a combination of capecitabine and Paclitaxel provide synergistic effects with improved tumour response A randomized phase III study could demonstrate a survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic breast cancer This synergistic effect is probably based on the preclinical observed taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell which give drive to an increased transformation of capecitabine to its active form 5-Fluorouracil Apart from this synergy the EC-TX regimen includes now 4 highly active compounds for the treatment of breast cancer The total doses of Epirubicin and Paclitaxel are identical in both arms The dosage of Cyclophosphamide is lower in the experimental arm which is preferred due to the induction of leukaemia at higher doses of Cyclophosphamide The duration of both arms with 18 and 20 weeks is nearly similar
The 2 by 2 factorial design of the trial provides the additional possibility to explore the efficacy of a bisphosphonate as another strategy to further improve the prognosis of node positive breast cancer
The experimental arm of EC-TX combines several strategies the combination of EC will be administered every 2 weeks as a dose-dense regimen the combination of TX can also be considered as dose-dense due to the weekly application of paclitaxel Furthermore there is clinical evidence that a combination of capecitabine and Paclitaxel provide synergistic effects with improved tumour response A randomized phase III study could demonstrate a survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic breast cancer This synergistic effect is probably based on the preclinical observed taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell which give drive to an increased transformation of capecitabine to its active form 5-Fluorouracil Apart from this synergy the EC-TX regimen includes now 4 highly active compounds for the treatment of breast cancer The total doses of Epirubicin and Paclitaxel are identical in both arms The dosage of Cyclophosphamide is lower in the experimental arm which is preferred due to the induction of leukaemia at higher doses of Cyclophosphamide The duration of both arms with 18 and 20 weeks is nearly similar
The 2 by 2 factorial design of the trial provides the additional possibility to explore the efficacy of a bisphosphonate as another strategy to further improve the prognosis of node positive breast cancer
Detailed Description:
Currently several strategies are under investigation to further improve adjuvant treatment of early node-positive breast cancer These are combination treatment of drugs with synergistic mode of action dose-dense application of cytotoxic drugs dose-intensification and the use of new non-cytotoxic approaches
In the recent AGO-study a dose-dense and dose-intensified sequence of Epirubicin - Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed sequence of Epirubicin Cyclophosphamid and Paclitaxel and was therefore chosen as standard treatment in this study
The experimental arm of EC-TX combines several of the above mentioned strategies the combination of EC will be administered every 2 weeks as a dose-dense regimen the combination of TX can also be considered as dose-dense due to the weekly application of paclitaxel Furthermore there is clinical evidence that a combination of capecitabine and Paclitaxel provide synergistic effects with improved tumour response A randomized phase III study could demonstrate a survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic breast cancer This synergistic effect is probably based on the preclinical observed taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell which give drive to an increased transformation of capecitabine to its active form 5-Fluorouracil Apart from this synergy the EC-TX regimen includes now 4 highly active compounds for the treatment of breast cancer The total doses of Epirubicin and Paclitaxel are identical in both arms The dosage of Cyclophosphamide is lower in the experimental arm which is preferred due to the induction of leukaemia at higher doses of Cyclophosphamide The duration of both arms with 18 and 20 weeks is nearly similar
The 2 by 2 factorial design of the trial provides the additional possibility to explore the efficacy of a bisphosphonate as another strategy to further improve the prognosis of node positive breast cancer As the mechanism of action of cytotoxic drugs and bisphosphonates appear to be independent the factorial design is an adequate statistical model for this trial Up to now only limited information is available on the potential role of bisphosphonates in this setting and they have all been generated by using the 1st generation bisphosphonate Clodronate 3rd generation bisphosphonates like ibandronate are much more active less toxic and their application is more convenient which is of high importance regarding the long duration of treatment
Primary aims of this trial are to improve disease-free survival by using the EC-TX regimen and by using ibandronate as adjuvant treatment for 2 years
In the recent AGO-study a dose-dense and dose-intensified sequence of Epirubicin - Paclitaxel - Cyclophosphamide has shown superior efficacy compared to a conventionally dosed sequence of Epirubicin Cyclophosphamid and Paclitaxel and was therefore chosen as standard treatment in this study
The experimental arm of EC-TX combines several of the above mentioned strategies the combination of EC will be administered every 2 weeks as a dose-dense regimen the combination of TX can also be considered as dose-dense due to the weekly application of paclitaxel Furthermore there is clinical evidence that a combination of capecitabine and Paclitaxel provide synergistic effects with improved tumour response A randomized phase III study could demonstrate a survival benefit of a combination of capecitabine with Docetaxel in patients with metastatic breast cancer This synergistic effect is probably based on the preclinical observed taxane-mediated up-regulation of thymidine phosphorylase in the tumour cell which give drive to an increased transformation of capecitabine to its active form 5-Fluorouracil Apart from this synergy the EC-TX regimen includes now 4 highly active compounds for the treatment of breast cancer The total doses of Epirubicin and Paclitaxel are identical in both arms The dosage of Cyclophosphamide is lower in the experimental arm which is preferred due to the induction of leukaemia at higher doses of Cyclophosphamide The duration of both arms with 18 and 20 weeks is nearly similar
The 2 by 2 factorial design of the trial provides the additional possibility to explore the efficacy of a bisphosphonate as another strategy to further improve the prognosis of node positive breast cancer As the mechanism of action of cytotoxic drugs and bisphosphonates appear to be independent the factorial design is an adequate statistical model for this trial Up to now only limited information is available on the potential role of bisphosphonates in this setting and they have all been generated by using the 1st generation bisphosphonate Clodronate 3rd generation bisphosphonates like ibandronate are much more active less toxic and their application is more convenient which is of high importance regarding the long duration of treatment
Primary aims of this trial are to improve disease-free survival by using the EC-TX regimen and by using ibandronate as adjuvant treatment for 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GAIN | None | None | None |