Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01378533
Status:
UNKNOWN
Last Update Posted:
2011-12-28
First Post:
2011-06-17
Brief Title:
The Trial Comparing Dose-dense AC-T With PC as Adjuvant Therapy for TNBC
Sponsor:
Chinese Academy of Medical Sciences
Organization:
ChineseAMS
Study Overview
Official Title:
Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2011-12
Last Known Status:
RECRUITING
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 purpose of this trial is to compare the 3 years DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer
The other purpose of this trial is to observe the patients tolerance
The other purpose of this trial is to observe the patients tolerance
Detailed Description:
Breast cancer are heterogeneous group of tumors with diverse behavior outcome and sensitivity to therapyIn recent years the term triple negative TN breast cancer has emerged to describe those cancers which do not express oestrogen ER progesterone PR receptors or Her2 Many studies had estimated that TN cases represents between 12-20 of all breast cancers Those TN case constitute one of the most challenging breast cancer groups with only systemic chemotherapy is currently available for their treatment
BRCA1 protein normally functions as a negative regulator of the cell cycle also BRCA1-positive tumors encompass a heterogeneous group of tumors that show distinctive pathological and clinical features BRCA1-associated cancers are typically high-grade invasive duct carcinoma and are mostly triple negativeThe phenotypic and molecular similarity of the TNBCs to BRCA1-associated BCs might be of use in designing their treatment protocol There is increasing evidence that the DNA repair defects that are characteristic of BRCA-1 related cancers may provide sensitivity to certain systemic agents to treat TNBC patients such as the bifunctional alkylating agents and platinum drugs
Dose density refers to the administration of drugs with a shortened intertreatment interval It is based on the observation that in experimental models a given dose always kills a certain fraction rather than a certain number of exponentially growing cancer cells Because human cancers in general and breast cancers in particular usually grow by nonexponential Gompertzian kinetics this model has been extended to those situations Regrowth of cancer cells between cycles of cytoreduction is more rapid in volume-reduced Gompertzian cancer models than in exponential models Hence it has been hypothesized that the more frequent administration of cytotoxic therapy would be a more effective way of minimizing residual tumor burden than dose escalation In the INT C9741 trial the dose-dense schedule is accomplished by using granulocyte colony-stimulating factor filgrastim to permit every-2-week recycling of the drugs A T and C at their optimal dose levels rather than at the conventional 3-week intervalsSequential therapy refers to the application of treatments one at a time rather than concurrently It does not challenge the concept that multiple drugs are needed to maximally perturb cancers that are composed of cells heterogeneous in drug sensitivity Rather it hypothesizes that for slow-growing cancers like most breast cancers it is more important to preserve dose density than to force a combination especially if that combination would be more toxic and requires dose-reductions or delays in drug administration If dose density is the same in a sequential combination chemotherapy regimen and a concurrent combination regimen theoretical considerations indicate that the therapeutic result should be the same even if the sequential pattern happens to be less toxic
In our trial we want to compare the 3 years DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancerThe other purpose of this trial is to observe the patients tolerance
BRCA1 protein normally functions as a negative regulator of the cell cycle also BRCA1-positive tumors encompass a heterogeneous group of tumors that show distinctive pathological and clinical features BRCA1-associated cancers are typically high-grade invasive duct carcinoma and are mostly triple negativeThe phenotypic and molecular similarity of the TNBCs to BRCA1-associated BCs might be of use in designing their treatment protocol There is increasing evidence that the DNA repair defects that are characteristic of BRCA-1 related cancers may provide sensitivity to certain systemic agents to treat TNBC patients such as the bifunctional alkylating agents and platinum drugs
Dose density refers to the administration of drugs with a shortened intertreatment interval It is based on the observation that in experimental models a given dose always kills a certain fraction rather than a certain number of exponentially growing cancer cells Because human cancers in general and breast cancers in particular usually grow by nonexponential Gompertzian kinetics this model has been extended to those situations Regrowth of cancer cells between cycles of cytoreduction is more rapid in volume-reduced Gompertzian cancer models than in exponential models Hence it has been hypothesized that the more frequent administration of cytotoxic therapy would be a more effective way of minimizing residual tumor burden than dose escalation In the INT C9741 trial the dose-dense schedule is accomplished by using granulocyte colony-stimulating factor filgrastim to permit every-2-week recycling of the drugs A T and C at their optimal dose levels rather than at the conventional 3-week intervalsSequential therapy refers to the application of treatments one at a time rather than concurrently It does not challenge the concept that multiple drugs are needed to maximally perturb cancers that are composed of cells heterogeneous in drug sensitivity Rather it hypothesizes that for slow-growing cancers like most breast cancers it is more important to preserve dose density than to force a combination especially if that combination would be more toxic and requires dose-reductions or delays in drug administration If dose density is the same in a sequential combination chemotherapy regimen and a concurrent combination regimen theoretical considerations indicate that the therapeutic result should be the same even if the sequential pattern happens to be less toxic
In our trial we want to compare the 3 years DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancerThe other purpose of this trial is to observe the patients tolerance
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 |
|---|---|---|---|
| CH-BC-012 | OTHER | cancer hospital chinese academy of medical sciences | None |