Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer
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ClinicalTrials.gov Identifier: NCT00636441 |
Recruitment Status :
Terminated
(Study terminated due to reproducibility issues with genomics prediction model)
First Posted : March 14, 2008
Results First Posted : October 7, 2014
Last Update Posted : December 11, 2015
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Early-Stage Breast Cancer |
Intervention |
Drug: Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC) |
Enrollment | 56 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Guided AC Sensitive | Guided TC Sensitive | Guided AC Non-sensitive | Guided TC Non-Sensitive | Non-guided AC | Non-guided TC | Screen Failure |
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Genomically-guided >60% probability of response to AC AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Genomically-guided treatment >60% probability of response to TC TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Non-genomics guided treatment; randomized to AC AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Non-genomics guided treatment; randomized to TC TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy |
[Not Specified] |
Period Title: Overall Study | |||||||
Started | 6 | 7 | 6 | 6 | 6 | 7 | 18 |
Assigned Treatment | 6 | 7 | 6 | 6 | 6 | 7 | 1 [1] |
Completed | 6 | 6 | 5 | 6 | 6 | 6 | 0 |
Not Completed | 0 | 1 | 1 | 0 | 0 | 1 | 18 |
Reason Not Completed | |||||||
Adverse Event | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
Late, ineligible | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Screen Failure | 0 | 0 | 0 | 0 | 0 | 0 | 17 |
[1]
This is a late determined ineligibility.
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Arm/Group Title | Guided AC Sensitive | Guided TC Sensitive | Guided AC Non-sensitive | Guided TC Non-Sensitive | Non-guided AC | Non-guided TC | Screen Failure | Total | |
---|---|---|---|---|---|---|---|---|---|
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Genomically-guided >60% probability of response to AC AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Genomically-guided treatment >60% probability of response to TC TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Non-genomics guided treatment; randomized to AC AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy |
Non-genomics guided treatment; randomized to TC TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy |
[Not Specified] | Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 7 | 6 | 6 | 6 | 7 | 18 | 56 | |
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All patients who signed a consent form are included in the baseline analysis.
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Age, Continuous
Median (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 6 participants | 7 participants | 6 participants | 6 participants | 6 participants | 7 participants | 18 participants | 56 participants | |
48.6 (8.7) | 51.2 (7.3) | 52.6 (8.0) | 48.8 (9.1) | 53.5 (6.7) | 58.9 (12.9) | 52.5 (13.0) | 52.4 (10.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 7 participants | 6 participants | 6 participants | 6 participants | 7 participants | 18 participants | 56 participants | |
Female |
6 100.0%
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7 100.0%
|
6 100.0%
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6 100.0%
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6 100.0%
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7 100.0%
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18 100.0%
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56 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 6 participants | 7 participants | 6 participants | 6 participants | 6 participants | 7 participants | 18 participants | 56 participants |
6 | 7 | 6 | 6 | 6 | 7 | 18 | 56 |
Name/Title: | P. Kelly Marcom, M.D. |
Organization: | Duke University Medical Center |
Phone: | 919-684-3877 |
EMail: | marco001@mc.duke.edu |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00636441 |
Other Study ID Numbers: |
Pro00001345 W81XWH-07-1-0394 BC060228-W81XWH-07-1-0394 |
First Submitted: | March 9, 2008 |
First Posted: | March 14, 2008 |
Results First Submitted: | May 7, 2014 |
Results First Posted: | October 7, 2014 |
Last Update Posted: | December 11, 2015 |