Ignite Creation Date:
2024-05-05 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00636441
Status:
TERMINATED
Last Update Posted:
2015-12-11
First Post:
2008-03-09
Brief Title:
Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Randomized Phase II Trial Evaluating the Performance of Genomic Expression Profiles to Direct the Use of Preoperative Chemotherapy for Early Stage Breast Cancer
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to reproducibility issues with genomics prediction model
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer patients to receive preoperative systemic chemotherapy in either a genomic-guided arm or a non-guided arm The genomic-guided method Arm 1 used genomic expression profiling to assign the preoperative therapy DoxorubicinCyclophosphamide AC versus DocetaxelCyclophosphamide TC while Arm 2 used random assignment to these two therapies
Detailed Description:
Primary Objective 1 was to test for an arm difference in pathological complete response rates Secondary Objective 2 was to estimate and test the difference in pathologic complete response rates between drug-sensitive patients who received their preferred drug and drug-resistant patients randomized to AC or TC
Secondary objectives included to determine the 60 cutoff for the genomic profiles resulted in a larger pathologic CR rate for the guided arm than for the unguided arm to compare the pathologic CR rates of patients whose genomic predictive probabilities indicated that they were resistant to both chemotherapy regimens with the pathologic CR rates of patients whose genomic predictive probabilities indicated that they were sensitive to only one treatment and who were then randomly assigned to a treatment for which they were resistant combining AC and TC subgroups Secondary Objective 3 in patients with T2 and T3 tumors classified as requiring mastectomy at baseline compare the guided and non-guided treatment arms on rates of breast conserving surgery with negative final margins Secondary Objective in patients with T2 tumors classified as potential candidates for breast conservation compare the guided and non-guided arms on rates of breast conserving surgery at first attempt Secondary Objectives 5 6 7 and 8 to correlate genomic profiles ie genomic predictive probabilities with clinical response disease-free survival sites of recurrence and overall survival Secondary Objective 9to compare the mean cost of guided versus non-guided treatment and Secondary Objective 10 to assess patient perceptions of participating in a clinical trial that evaluated cancer genomics for preoperative systemic therapy of early-stage breast cancer
Objective 10 details Due to space limitations in the Outcome Measure Description field details are supplied here
To assess patient motivation and participation for study participation in a clinical trial evaluating cancer genomics for treatment patients provided responses for the following questions at both baseline the day of chemotherapy start and following post-surgical medical oncology evaluation
One of the goals of this study is to tailor your cancer treatments for you based upon a genomic analysis of your tumor How much did the knowledge that the treatment is potentially tailored specifically for your tumor influence your decision to participate in this study Select One
Response 1 I did not know that the treatment was tailored
Response 2 I do not understand what tailored treatment based upon genomic analysis of my tumor means
Response 3 The information that this was a tailored treatment based upon genomic analysis of my tumor decreased my willingness to participate in this study
Response 4 The information that this was a tailored treatment based upon genomic analysis of my tumor was of neutral value in the decision making process to participate in this study and did not influence my decision to participate
Response 5 The information that this was a tailored treatment based upon genomic analysis of my tumor played a minor role in helping me decide to participate in the study
Response 6 The information that this was a tailored treatment based upon genomic analysis of my tumor played a major role in helping me decide to participate in the study
Response 7 The information that this was a tailored treatment based upon genomic analysis of my tumor was the primary reason that I decided to participate in the study
Secondary objectives included to determine the 60 cutoff for the genomic profiles resulted in a larger pathologic CR rate for the guided arm than for the unguided arm to compare the pathologic CR rates of patients whose genomic predictive probabilities indicated that they were resistant to both chemotherapy regimens with the pathologic CR rates of patients whose genomic predictive probabilities indicated that they were sensitive to only one treatment and who were then randomly assigned to a treatment for which they were resistant combining AC and TC subgroups Secondary Objective 3 in patients with T2 and T3 tumors classified as requiring mastectomy at baseline compare the guided and non-guided treatment arms on rates of breast conserving surgery with negative final margins Secondary Objective in patients with T2 tumors classified as potential candidates for breast conservation compare the guided and non-guided arms on rates of breast conserving surgery at first attempt Secondary Objectives 5 6 7 and 8 to correlate genomic profiles ie genomic predictive probabilities with clinical response disease-free survival sites of recurrence and overall survival Secondary Objective 9to compare the mean cost of guided versus non-guided treatment and Secondary Objective 10 to assess patient perceptions of participating in a clinical trial that evaluated cancer genomics for preoperative systemic therapy of early-stage breast cancer
Objective 10 details Due to space limitations in the Outcome Measure Description field details are supplied here
To assess patient motivation and participation for study participation in a clinical trial evaluating cancer genomics for treatment patients provided responses for the following questions at both baseline the day of chemotherapy start and following post-surgical medical oncology evaluation
One of the goals of this study is to tailor your cancer treatments for you based upon a genomic analysis of your tumor How much did the knowledge that the treatment is potentially tailored specifically for your tumor influence your decision to participate in this study Select One
Response 1 I did not know that the treatment was tailored
Response 2 I do not understand what tailored treatment based upon genomic analysis of my tumor means
Response 3 The information that this was a tailored treatment based upon genomic analysis of my tumor decreased my willingness to participate in this study
Response 4 The information that this was a tailored treatment based upon genomic analysis of my tumor was of neutral value in the decision making process to participate in this study and did not influence my decision to participate
Response 5 The information that this was a tailored treatment based upon genomic analysis of my tumor played a minor role in helping me decide to participate in the study
Response 6 The information that this was a tailored treatment based upon genomic analysis of my tumor played a major role in helping me decide to participate in the study
Response 7 The information that this was a tailored treatment based upon genomic analysis of my tumor was the primary reason that I decided to participate in the study
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 |
|---|---|---|---|
| BC060228-W81XWH-07-1-0394 | None | None | None |
| W81XWH-07-1-0394 | None | None | None |