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

Sponsor:

Collaborator:

United States Department of Defense

Information provided by (Responsible Party):

Duke University

Study Type	Interventional
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

Participant Flow

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
Arm/Group Description	Genomically-guided >60% probability...	Genomically-guided treatment >60% p...	Genomics guided treatment <60% prob...	Genomics guided treatment <60% prob...	Non-genomics guided treatment; rand...	Non-genomics guided treatment; rand...
Arm/Group Description	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.

Baseline Characteristics

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
Arm/Group Description		Genomically-guided >60% probability...	Genomically-guided treatment >60% p...	Genomics guided treatment <60% prob...	Genomics guided treatment <60% prob...	Non-genomics guided treatment; rand...	Non-genomics guided treatment; rand...	[Not Specified]	Total of all reporting groups
Arm/Group Description		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
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All patients who signed a consent form are included in the baseline analysis.
Age, Continuous Median (Standard Deviation) Unit of measure: Years
	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
	Number Analyzed	6 participants	7 participants	6 participants	6 participants	6 participants	7 participants	18 participants	56 participants
	Female	6 100.0%	7 100.0%	6 100.0%	6 100.0%	6 100.0%	7 100.0%	18 100.0%	56 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	6 participants	7 participants	6 participants	6 participants	6 participants	7 participants	18 participants	56 participants
United States		6	7	6	6	6	7	18	56

Outcome Measures

1.Primary Outcome


Title	Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer
Description	Pathological complete response (pCR) was defined as the disappearance ...
Description	Pathological complete response (pCR) was defined as the disappearance of all invasive disease in the breast or if only residual in situ or lymph node disease is found. The pCR rate is presented with its 95% confidence interval for the Guided and Non-guided arms.
Time Frame	4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks

Outcome Measure Data

Analysis Population Description

All eligible treated patients. The three patients not included are two who had allergic reactions to the assigned treatment, and one with metastatic disease on biopsy of a spine lesion at the end of assigned treatment so never went to surgery.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	24	11
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	16.7 (4.7 to 37.4)	9.1 (0.2 to 41.3)

2.Secondary Outcome


Title	Probabilities of Being Sensitive to AC and TC as Determined by the Patient's Genomic Signatures
Description	To determine in early stage breast cancer treated with PST whether gen...
Description	To determine in early stage breast cancer treated with PST whether genomic profiling can identify drug-sensitive and drug-resistant patients including a comparison of subgroups for the two individual regimens (i.e. AC and TC). To determine if the 60% cutoff for the genomic profiles is optimal in predicting the response to chemotherapy regimens.To describe the performance of the genomic profiles in assessing the relative responsiveness of: 1) Patients predicted to be resistant to both chemotherapy regimens; and 2) Patients randomly assigned to one treatment whose genomic profiles suggest receiving the other regimen (in both AC and TC subgroups).
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

3.Secondary Outcome


Title	Percentage of Patients Who Had Breast-conserving Surgery With Negative Margins
Description	The percentage of patients who had breast-conserving surgery with nega...
Description	The percentage of patients who had breast-conserving surgery with negative margins, measured in patients with T2 and T3 tumors classified as requiring mastectomy at baseline.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Since final margin status was not collected, this analysis could not be done.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

4.Secondary Outcome


Title	To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.
Description	The percentage of patients who had breast-conserving surgery at first ...
Description	The percentage of patients who had breast-conserving surgery at first attempt, measured only in patients with T2 tumors classified as potential candidates for breast conservation.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data from all eligible patients with non-missing values on this outcome were used.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	3	1
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of T2 tumor patients
	67 (9 to 99)	100 ^[1] (NA to NA)

[1]

can not calculate confidence interval N of 1.

5.Secondary Outcome


Title	Clinical Response Using WHO Criteria
Description	WHO criteria are based on the sum of the products of the longest axis ...
Description	WHO criteria are based on the sum of the products of the longest axis and the longest perpendicular axis. Bi-dimensional measurements were taken of all breast lesions and axillary nodes using the best imaging modality performed after completion of assigned therapy. Clinical Complete Response (cCR): Disappearance of all target lesions by physical exam and best imaging modality. Clinical Partial Response (cPR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum LD at treatment initiation. Patients having a documented response with no reconfirmation of the response will be listed with stable disease. Progression (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesion.
Time Frame	12 weeks, 2-3 weeks after the fourth cycle of chemotherapy

Outcome Measure Data

Analysis Population Description

All eligible treated patients were used in this analysis.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	25	13
Measure Type: Number Unit of Measure: participants
Complete Response (cCR)	2	2
Partial Response (cPR)	15	7
Stable Disease	6	2
Progressive Disease	1	0
Not Evaluable/Not Assessed	1	2

6.Secondary Outcome


Title	Disease-free Survival
Description	Disease-free survival is defined as the length of time from enrollment...
Description	Disease-free survival is defined as the length of time from enrollment to local or distant disease recurrence, whichever comes first; disease-free deaths are censored. The 2-year disease-free survival rate is estimated with its 95% confidence interval.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

All eligible treated patients were used in this analysis.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	25	13
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: estimated % of participants disease-free
	92 (71 to 98)	89 (43 to 98)

7.Secondary Outcome


Title	Sites of Recurrence
Description	Sites of Recurrence is a categorical outcome whose possible values are...
Description	Sites of Recurrence is a categorical outcome whose possible values are the organ-specific sites at which disease recurrence was observed. A patient may recur at more than one site.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

All eligible treated patients. Four of these 38 participants experienced recurrence of their breast cancer; two of the four patients had multiple sites of recurrence.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	25	13
Measure Type: Number Unit of Measure: participants
Bone	3	1
Brain	1	0
Chest Wall	1	0
Liver	2	0
Lung	1	0

8.Secondary Outcome


Title	Overall Survival
Description	Overall survival is defined as the time from enrollment to death due t...
Description	Overall survival is defined as the time from enrollment to death due to any cause. The 2-year overall survival rate is estimated with the Kaplan-Meier method.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

All eligible treated patients with known follow-up status.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	24	12
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Estimated % of participants surviving
	96 (74 to 99)	100 ^[1] (NA to NA)

[1]

Since no deaths occurred on or before the 2-year time point a confidence interval cannot be estimated.

9.Secondary Outcome


Title	Economic Impact of Using Genomic Assessment to Guide Management.
Description	Economic Impact (i.e., cost of care) will be calculated by first asses...
Description	Economic Impact (i.e., cost of care) will be calculated by first assessing the quantity of clinical resources used by each patient in the study arm, and then assigning a cost to each resource using cost information derived from a costing study to be undertaken outside of this protocol.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Since these data were not collected, this analysis could not be done.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

10.Secondary Outcome


Title	Patients' Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for PST of Early-stage Breast Cancer.
Description	A short questionnaire was administered at baseline (the day chemothera...
Description	A short questionnaire was administered at baseline (the day chemotherapy was started) and following post-surgical medical oncology evaluation to assess the patient's understanding of the study being conducted, and the patient's expectations of the treatment. Due to space limitations, the full survey is presented in the Detailed Description.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The overall enrollment was insufficient to provide for any substantive analysis.


Arm/Group Title	Guided Arm	Non-Guided Arm
Arm/Group Description:	Genomically-guided treatment alloca...	Non-genomically-guided treatment al...
Arm/Group Description:	Genomically-guided treatment allocation.	Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Guided AC Sensitive	Guided TC Sensitive	Guided AC Non-sensitive	Guided TC Non-Sensitive	Non-guided AC	Non-guided TC	Screen Failures
Arm/Group Description	Genomically-guided >60% probability...	Genomically-guided treatment >60% p...	Genomics guided treatment <60% prob...	Genomics guided treatment <60% prob...	Non-genomics guided treatment; rand...	Non-genomics guided treatment; rand...	Screen failures constitute patients...
Arm/Group Description	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	Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
All-Cause Mortality
	Guided AC Sensitive	Guided TC Sensitive	Guided AC Non-sensitive	Guided TC Non-Sensitive	Non-guided AC	Non-guided TC	Screen Failures
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Guided AC Sensitive	Guided TC Sensitive	Guided AC Non-sensitive	Guided TC Non-Sensitive	Non-guided AC	Non-guided TC	Screen Failures
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/6 (33.33%)	0/7 (0.00%)	3/6 (50.00%)	2/6 (33.33%)	1/6 (16.67%)	2/7 (28.57%)	1/18 (5.56%)
Blood and lymphatic system disorders
Anemia ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	1/18 (5.56%)
Febrile neutropenia ^† 1	1/6 (16.67%)	0/7 (0.00%)	1/6 (16.67%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Ear and labyrinth disorders
Ear and labyrinth disorders: ear complete hearing loss ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Immune system disorders
Allergic reaction ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Infections and infestations
Infections and infestations: Infection with neutrophils: Abdomen NOS ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Infections and infestations: UTI ^† 1	1/6 (16.67%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Investigations
Neutrophil count decreased ^† 1	2/6 (33.33%)	0/7 (0.00%)	2/6 (33.33%)	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
White blood cell decreased ^† 1	1/6 (16.67%)	0/7 (0.00%)	1/6 (16.67%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE (4.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Guided AC Sensitive	Guided TC Sensitive	Guided AC Non-sensitive	Guided TC Non-Sensitive	Non-guided AC	Non-guided TC	Screen Failures
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/6 (100.00%)	7/7 (100.00%)	6/6 (100.00%)	6/6 (100.00%)	6/6 (100.00%)	7/7 (100.00%)	1/18 (5.56%)
Blood and lymphatic system disorders
Anemia ^† 1	3/6 (50.00%)	3/7 (42.86%)	1/6 (16.67%)	2/6 (33.33%)	1/6 (16.67%)	3/7 (42.86%)	0/18 (0.00%)
Lymph node pain ^† 1	2/6 (33.33%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Cardiac disorders
Cardiac disorders: Tachycardia ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Cardiac disorders: palpitations ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Palpitations ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	1/6 (16.67%)	2/6 (33.33%)	1/7 (14.29%)	0/18 (0.00%)
Ear and labyrinth disorders
External ear inflammation ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Tinnitus ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Eye disorders
Blurred vision ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	2/7 (28.57%)	0/18 (0.00%)
Dry eye ^† 1	0/6 (0.00%)	0/7 (0.00%)	2/6 (33.33%)	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
Extraocular muscle paresis ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Eye disorders: eye lids twitching ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Watering eyes ^† 1	0/6 (0.00%)	2/7 (28.57%)	1/6 (16.67%)	1/6 (16.67%)	1/6 (16.67%)	2/7 (28.57%)	0/18 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/6 (16.67%)	0/7 (0.00%)	0/6 (0.00%)	2/6 (33.33%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Anal mucositis ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Ascites ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Constipation ^† 1	2/6 (33.33%)	5/7 (71.43%)	4/6 (66.67%)	3/6 (50.00%)	4/6 (66.67%)	3/7 (42.86%)	0/18 (0.00%)
Diarrhea ^† 1	1/6 (16.67%)	4/7 (57.14%)	1/6 (16.67%)	3/6 (50.00%)	1/6 (16.67%)	3/7 (42.86%)	0/18 (0.00%)
Dry mouth ^† 1	1/6 (16.67%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Dyspepsia ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	2/6 (33.33%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Dysphagia ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Esophagitis ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Gastrointestinal disorders: inflamed gums ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Hemorrhoids ^† 1	2/6 (33.33%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	1/6 (16.67%)	2/7 (28.57%)	0/18 (0.00%)
Mucositis oral ^† 1	2/6 (33.33%)	3/7 (42.86%)	2/6 (33.33%)	3/6 (50.00%)	1/6 (16.67%)	3/7 (42.86%)	0/18 (0.00%)
Nausea ^† 1	2/6 (33.33%)	2/7 (28.57%)	4/6 (66.67%)	2/6 (33.33%)	2/6 (33.33%)	3/7 (42.86%)	0/18 (0.00%)
Rectal hemorrhage ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
Rectal pain ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
Vomiting ^† 1	3/6 (50.00%)	1/7 (14.29%)	3/6 (50.00%)	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
General disorders
Edema face ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Edema limbs ^† 1	2/6 (33.33%)	3/7 (42.86%)	1/6 (16.67%)	1/6 (16.67%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Edema trunk ^† 1	2/6 (33.33%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Fatigue ^† 1	2/6 (33.33%)	5/7 (71.43%)	5/6 (83.33%)	6/6 (100.00%)	5/6 (83.33%)	6/7 (85.71%)	0/18 (0.00%)
Fever ^† 1	1/6 (16.67%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
General disorders and administration site conditions: cold intolerance ^† 1	1/6 (16.67%)	2/7 (28.57%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Non-cardiac chest pain ^† 1	0/6 (0.00%)	1/7 (14.29%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Pain ^† 1	1/6 (16.67%)	1/7 (14.29%)	1/6 (16.67%)	2/6 (33.33%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Immune system disorders
Allergic reaction ^† 1	0/6 (0.00%)	2/7 (28.57%)	1/6 (16.67%)	1/6 (16.67%)	0/6 (0.00%)	2/7 (28.57%)	0/18 (0.00%)
Infections and infestations
Infections and infestations: UTI ^† 1	2/6 (33.33%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Lymph gland infection ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Urinary tract infection ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Vaginal infection ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Injury, poisoning and procedural complications
Bruising ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	0/6 (0.00%)	1/7 (14.29%)	1/6 (16.67%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Alkaline phosphatase increased ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Aspartate aminotransferase increased ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Neutrophil count decreased ^† 1	1/6 (16.67%)	0/7 (0.00%)	3/6 (50.00%)	1/6 (16.67%)	2/6 (33.33%)	1/7 (14.29%)	0/18 (0.00%)
Platelet count decreased ^† 1	1/6 (16.67%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Weight gain ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Weight loss ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
White blood cell decreased ^† 1	2/6 (33.33%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	2/6 (33.33%)	2/7 (28.57%)	0/18 (0.00%)
Metabolism and nutrition disorders
Acidosis ^† 1	1/6 (16.67%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Anorexia ^† 1	0/6 (0.00%)	2/7 (28.57%)	1/6 (16.67%)	5/6 (83.33%)	1/6 (16.67%)	5/7 (71.43%)	0/18 (0.00%)
Hyperglycemia ^† 1	2/6 (33.33%)	2/7 (28.57%)	0/6 (0.00%)	2/6 (33.33%)	0/6 (0.00%)	4/7 (57.14%)	0/18 (0.00%)
Hyperkalemia ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Hypernatremia ^† 1	1/6 (16.67%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Hypocalcemia ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Hypokalemia ^† 1	1/6 (16.67%)	0/7 (0.00%)	2/6 (33.33%)	1/6 (16.67%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Hyponatremia ^† 1	1/6 (16.67%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	2/6 (33.33%)	2/7 (28.57%)	3/6 (50.00%)	2/6 (33.33%)	0/6 (0.00%)	5/7 (71.43%)	0/18 (0.00%)
Arthritis ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Back pain ^† 1	4/6 (66.67%)	1/7 (14.29%)	0/6 (0.00%)	1/6 (16.67%)	1/6 (16.67%)	2/7 (28.57%)	0/18 (0.00%)
Bone pain ^† 1	0/6 (0.00%)	1/7 (14.29%)	1/6 (16.67%)	1/6 (16.67%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Chest wall pain ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Generalized muscle weakness ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Musculoskeletal and connective tissue disorder : muscle tightness ^† 1	0/6 (0.00%)	1/7 (14.29%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Myalgia ^† 1	1/6 (16.67%)	2/7 (28.57%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Neck pain ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	2/7 (28.57%)	0/18 (0.00%)
Pain in extremity ^† 1	2/6 (33.33%)	2/7 (28.57%)	1/6 (16.67%)	1/6 (16.67%)	1/6 (16.67%)	2/7 (28.57%)	0/18 (0.00%)
Nervous system disorders
Ataxia ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Dizziness ^† 1	0/6 (0.00%)	2/7 (28.57%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	2/7 (28.57%)	0/18 (0.00%)
Dysgeusia ^† 1	3/6 (50.00%)	3/7 (42.86%)	2/6 (33.33%)	3/6 (50.00%)	0/6 (0.00%)	4/7 (57.14%)	0/18 (0.00%)
Headache ^† 1	5/6 (83.33%)	4/7 (57.14%)	5/6 (83.33%)	5/6 (83.33%)	4/6 (66.67%)	3/7 (42.86%)	0/18 (0.00%)
Memory impairment ^† 1	1/6 (16.67%)	1/7 (14.29%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Peripheral sensory neuropathy ^† 1	3/6 (50.00%)	3/7 (42.86%)	2/6 (33.33%)	1/6 (16.67%)	2/6 (33.33%)	4/7 (57.14%)	0/18 (0.00%)
Sinus pain ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Syncope ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Psychiatric disorders
Agitation ^† 1	1/6 (16.67%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Anxiety ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	3/6 (50.00%)	1/7 (14.29%)	0/18 (0.00%)
Depression ^† 1	1/6 (16.67%)	4/7 (57.14%)	0/6 (0.00%)	2/6 (33.33%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Insomnia ^† 1	3/6 (50.00%)	4/7 (57.14%)	3/6 (50.00%)	4/6 (66.67%)	2/6 (33.33%)	4/7 (57.14%)	0/18 (0.00%)
Renal and urinary disorders
Cystitis noninfective ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Urinary frequency ^† 1	1/6 (16.67%)	0/7 (0.00%)	2/6 (33.33%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Urinary tract pain ^† 1	1/6 (16.67%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
Reproductive system and breast disorders
Breast pain ^† 1	2/6 (33.33%)	3/7 (42.86%)	1/6 (16.67%)	3/6 (50.00%)	3/6 (50.00%)	0/7 (0.00%)	1/18 (5.56%)
Uterine pain ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Vaginal discharge ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Vaginal dryness ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Vaginal pain ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^† 1	3/6 (50.00%)	2/7 (28.57%)	6/6 (100.00%)	3/6 (50.00%)	3/6 (50.00%)	3/7 (42.86%)	0/18 (0.00%)
Bronchospasm ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Cough ^† 1	3/6 (50.00%)	0/7 (0.00%)	2/6 (33.33%)	2/6 (33.33%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Dyspnea ^† 1	1/6 (16.67%)	1/7 (14.29%)	3/6 (50.00%)	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Laryngeal mucositis ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Pharyngolaryngeal pain ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	2/7 (28.57%)	0/18 (0.00%)
Respiratory, thoracic and mediastinal disorders: dyspnea on exertion ^† 1	0/6 (0.00%)	1/7 (14.29%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Sinus disorder ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
Voice alteration ^† 1	0/6 (0.00%)	1/7 (14.29%)	2/6 (33.33%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	5/6 (83.33%)	5/7 (71.43%)	2/6 (33.33%)	2/6 (33.33%)	5/6 (83.33%)	2/7 (28.57%)	0/18 (0.00%)
Dry skin ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Hyperhidrosis ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/6 (16.67%)	0/7 (0.00%)	0/18 (0.00%)
Nail loss ^† 1	1/6 (16.67%)	0/7 (0.00%)	2/6 (33.33%)	0/6 (0.00%)	1/6 (16.67%)	3/7 (42.86%)	0/18 (0.00%)
Palmar-plantar erythrodysesthesia syndrome ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Pruritus ^† 1	3/6 (50.00%)	1/7 (14.29%)	1/6 (16.67%)	1/6 (16.67%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Purpura ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Rash acneiform ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Rash maculo-papular ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Skin and subcutaneous tissue disorders: nose sores ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Skin ulceration ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Vascular disorders
Flushing ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Hematoma ^† 1	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/7 (14.29%)	0/18 (0.00%)
Hot flashes ^† 1	2/6 (33.33%)	3/7 (42.86%)	3/6 (50.00%)	1/6 (16.67%)	2/6 (33.33%)	3/7 (42.86%)	0/18 (0.00%)
Hypertension ^† 1	1/6 (16.67%)	0/7 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/7 (14.29%)	0/18 (0.00%)
Vascular disorders: easy bruising ^† 1	0/6 (0.00%)	0/7 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
Vascular disorders: epitaxsis ^† 1	0/6 (0.00%)	1/7 (14.29%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/18 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE (4.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	P. Kelly Marcom, M.D.
Organization:	Duke University Medical Center
Phone:	919-684-3877
EMail:	marco001@mc.duke.edu

Publications:

Potti A, Dressman HK, Bild A, Riedel RF, Chan G, Sayer R, Cragun J, Cottrill H, Kelley MJ, Petersen R, Harpole D, Marks J, Berchuck A, Ginsburg GS, Febbo P, Lancaster J, Nevins JR. Genomic signatures to guide the use of chemotherapeutics. Nat Med. 2006 Nov;12(11):1294-300. Epub 2006 Oct 22. Erratum in: Nat Med. 2007 Nov;13(11):1388. Nat Med. 2008 Aug;14(8):889. Retraction in: Potti A, Dressman HK, Bild A, Riedel RF, Chan G, Sayer R, Cragun J, Cottrill H, Kelley MJ, Petersen R, Harpole D, Marks J, Berchuck A, Ginsburg GS, Febbo P, Lancaster J, Nevins JR. Nat Med. 2011 Jan;17(1):135.

Retraction in: Potti A, Dressman HK, Bild A, Riedel RF, Chan G, Sayer R, Cragun J, Cottrill H, Kelley MJ, Petersen R, Harpole D, Marks J, Berchuck A, Ginsburg GS, Febbo P, Lancaster J, Nevins JR. Nat Med. 2011 Jan;17(1):135

Layout table for additonal information

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

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