Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01204437
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2010-09-10
Brief Title:
Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
Official Title:
An Investigational Randomized Study on Epirubicin Plus Cyclophospamide EC or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil CMF Versus Nab-paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast
Status:
COMPLETED
Status Verified Date:
2016-02
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:
ICE-II
Brief Summary:
Although approximately 50 of new diagnosis breast cancers are in patients above the age of 65 elderly people remain substantially under-represented in clinical trials and therefore are under-treated A recent trial of the CALBG in patients 65 years with medium risk of breast cancer demonstrated an improved disease-free and overall survival for those treated with AC or CMF compared to those treated with capecitabine alone
The primary aim of the ICE II trial is to determine the compliance and toxicity of epirubicin plus cyclophosphamide EC or CMF versus nab-paclitaxel plus capecitabine as adjuvant therapy in non frail elderly patients
The primary aim of the ICE II trial is to determine the compliance and toxicity of epirubicin plus cyclophosphamide EC or CMF versus nab-paclitaxel plus capecitabine as adjuvant therapy in non frail elderly patients
Detailed Description:
Primary Objective
Phase II
To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF ECCMF and nab-paclitaxel in combination with capecitabine PX
Secondary Objectives
1 To compare the disease-free survival DFS and distant disease free survival DDFS with epirubicin plus cyclophosphamide or CMF ECCMF vs nab-paclitaxel in combination with capecitabine PX
2 To compare the overall survival OS with epirubicin plus cyclophosphamide or CMF ECCMF vs nab-paclitaxel in combination with capecitabine PX
3 To analyze the efficacy of treatments in subgroups according to clinical stratification factors
4 To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect
5 To compare the geriatric assessments scores Charlson VES-13 IADL G8 at baseline and end of therapy
Phase II
To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF ECCMF and nab-paclitaxel in combination with capecitabine PX
Secondary Objectives
1 To compare the disease-free survival DFS and distant disease free survival DDFS with epirubicin plus cyclophosphamide or CMF ECCMF vs nab-paclitaxel in combination with capecitabine PX
2 To compare the overall survival OS with epirubicin plus cyclophosphamide or CMF ECCMF vs nab-paclitaxel in combination with capecitabine PX
3 To analyze the efficacy of treatments in subgroups according to clinical stratification factors
4 To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect
5 To compare the geriatric assessments scores Charlson VES-13 IADL G8 at baseline and end of therapy
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 |
|---|---|---|---|
| 2008-003995-23 | EUDRACT_NUMBER | None | None |