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Trial Outcomes & Findings for Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer (NCT NCT00636441)

NCT ID: NCT00636441

Last Updated: 2015-12-11

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks

Results posted on

2015-12-11

Participant Flow

Participant milestones

Participant milestones
Measure
Guided AC Sensitive
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
Guided TC Sensitive
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
Guided AC Non-sensitive
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
Guided TC Non-Sensitive
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-guided AC
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-guided TC
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 Failure
Overall Study
STARTED
6
7
6
6
6
7
18
Overall Study
Assigned Treatment
6
7
6
6
6
7
1
Overall Study
COMPLETED
6
6
5
6
6
6
0
Overall Study
NOT COMPLETED
0
1
1
0
0
1
18

Reasons for withdrawal

Reasons for withdrawal
Measure
Guided AC Sensitive
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
Guided TC Sensitive
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
Guided AC Non-sensitive
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
Guided TC Non-Sensitive
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-guided AC
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-guided TC
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 Failure
Overall Study
Adverse Event
0
1
1
0
0
1
0
Overall Study
Late, ineligible
0
0
0
0
0
0
1
Overall Study
Screen Failure
0
0
0
0
0
0
17

Baseline Characteristics

Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Guided AC Sensitive
n=6 Participants
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
Guided TC Sensitive
n=7 Participants
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
Guided AC Non-sensitive
n=6 Participants
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
Guided TC Non-Sensitive
n=6 Participants
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-guided AC
n=6 Participants
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-guided TC
n=7 Participants
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 Failure
n=18 Participants
Total
n=56 Participants
Total of all reporting groups
Age, Continuous
48.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
51.2 years
STANDARD_DEVIATION 7.3 • n=7 Participants
52.6 years
STANDARD_DEVIATION 8.0 • n=5 Participants
48.8 years
STANDARD_DEVIATION 9.1 • n=4 Participants
53.5 years
STANDARD_DEVIATION 6.7 • n=21 Participants
58.9 years
STANDARD_DEVIATION 12.9 • n=10 Participants
52.5 years
STANDARD_DEVIATION 13.0 • n=115 Participants
52.4 years
STANDARD_DEVIATION 10.5 • n=6 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
7 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
6 Participants
n=21 Participants
7 Participants
n=10 Participants
18 Participants
n=115 Participants
56 Participants
n=6 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
Region of Enrollment
United States
6 participants
n=5 Participants
7 participants
n=7 Participants
6 participants
n=5 Participants
6 participants
n=4 Participants
6 participants
n=21 Participants
7 participants
n=10 Participants
18 participants
n=115 Participants
56 participants
n=6 Participants

PRIMARY outcome

Timeframe: 4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Guided Arm
n=24 Participants
Genomically-guided treatment allocation.
Non-Guided Arm
n=11 Participants
Non-genomically-guided treatment allocation.
Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer
16.7 percentage of participants
Interval 4.7 to 37.4
9.1 percentage of participants
Interval 0.2 to 41.3

SECONDARY outcome

Timeframe: 10 years

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

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Outcome measures
Measure
Guided Arm
n=3 Participants
Genomically-guided treatment allocation.
Non-Guided Arm
n=1 Participants
Non-genomically-guided treatment allocation.
To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.
67 percentage of T2 tumor patients
Interval 9.0 to 99.0
100 percentage of T2 tumor patients
can not calculate confidence interval N of 1.

SECONDARY outcome

Timeframe: 12 weeks, 2-3 weeks after the fourth cycle of chemotherapy

Population: All eligible treated patients were used in this analysis.

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.

Outcome measures

Outcome measures
Measure
Guided Arm
n=25 Participants
Genomically-guided treatment allocation.
Non-Guided Arm
n=13 Participants
Non-genomically-guided treatment allocation.
Clinical Response Using WHO Criteria
Complete Response (cCR)
2 participants
2 participants
Clinical Response Using WHO Criteria
Partial Response (cPR)
15 participants
7 participants
Clinical Response Using WHO Criteria
Stable Disease
6 participants
2 participants
Clinical Response Using WHO Criteria
Progressive Disease
1 participants
0 participants
Clinical Response Using WHO Criteria
Not Evaluable/Not Assessed
1 participants
2 participants

SECONDARY outcome

Timeframe: 2 years

Population: All eligible treated patients were used in this analysis.

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.

Outcome measures

Outcome measures
Measure
Guided Arm
n=25 Participants
Genomically-guided treatment allocation.
Non-Guided Arm
n=13 Participants
Non-genomically-guided treatment allocation.
Disease-free Survival
92 estimated % of participants disease-free
Interval 71.0 to 98.0
89 estimated % of participants disease-free
Interval 43.0 to 98.0

SECONDARY outcome

Timeframe: 10 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Guided Arm
n=25 Participants
Genomically-guided treatment allocation.
Non-Guided Arm
n=13 Participants
Non-genomically-guided treatment allocation.
Sites of Recurrence
Bone
3 participants
1 participants
Sites of Recurrence
Brain
1 participants
0 participants
Sites of Recurrence
Chest Wall
1 participants
0 participants
Sites of Recurrence
Liver
2 participants
0 participants
Sites of Recurrence
Lung
1 participants
0 participants

SECONDARY outcome

Timeframe: 2 years

Population: All eligible treated patients with known follow-up status.

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.

Outcome measures

Outcome measures
Measure
Guided Arm
n=24 Participants
Genomically-guided treatment allocation.
Non-Guided Arm
n=12 Participants
Non-genomically-guided treatment allocation.
Overall Survival
96 Estimated % of participants surviving
Interval 74.0 to 99.0
100 Estimated % of participants surviving
Since no deaths occurred on or before the 2-year time point a confidence interval cannot be estimated.

SECONDARY outcome

Timeframe: 5 years

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Guided AC Sensitive

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

Guided TC Sensitive

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Guided AC Non-sensitive

Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths

Guided TC Non-Sensitive

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

Non-guided AC

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Non-guided TC

Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths

Screen Failures

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Guided AC Sensitive
n=6 participants at risk
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
Guided TC Sensitive
n=7 participants at risk
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
Guided AC Non-sensitive
n=6 participants at risk
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
Guided TC Non-Sensitive
n=6 participants at risk
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-guided AC
n=6 participants at risk
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-guided TC
n=7 participants at risk
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
n=18 participants at risk
Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
Blood and lymphatic system disorders
Anemia
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
5.6%
1/18
Blood and lymphatic system disorders
Febrile neutropenia
16.7%
1/6
0.00%
0/7
16.7%
1/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Ear and labyrinth disorders
Ear and labyrinth disorders: ear complete hearing loss
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Gastrointestinal disorders
Abdominal pain
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Immune system disorders
Allergic reaction
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Infections and infestations
Infections and infestations: Infection with neutrophils: Abdomen NOS
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Infections and infestations
Infections and infestations: UTI
16.7%
1/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Investigations
Neutrophil count decreased
33.3%
2/6
0.00%
0/7
33.3%
2/6
16.7%
1/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Investigations
White blood cell decreased
16.7%
1/6
0.00%
0/7
16.7%
1/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18

Other adverse events

Other adverse events
Measure
Guided AC Sensitive
n=6 participants at risk
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
Guided TC Sensitive
n=7 participants at risk
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
Guided AC Non-sensitive
n=6 participants at risk
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
Guided TC Non-Sensitive
n=6 participants at risk
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-guided AC
n=6 participants at risk
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-guided TC
n=7 participants at risk
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
n=18 participants at risk
Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
Blood and lymphatic system disorders
Anemia
50.0%
3/6
42.9%
3/7
16.7%
1/6
33.3%
2/6
16.7%
1/6
42.9%
3/7
0.00%
0/18
Blood and lymphatic system disorders
Lymph node pain
33.3%
2/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Cardiac disorders
Cardiac disorders: Tachycardia
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Cardiac disorders
Cardiac disorders: palpitations
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Cardiac disorders
Palpitations
0.00%
0/6
0.00%
0/7
16.7%
1/6
16.7%
1/6
33.3%
2/6
14.3%
1/7
0.00%
0/18
Ear and labyrinth disorders
External ear inflammation
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Ear and labyrinth disorders
Tinnitus
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Eye disorders
Blurred vision
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
28.6%
2/7
0.00%
0/18
Eye disorders
Dry eye
0.00%
0/6
0.00%
0/7
33.3%
2/6
0.00%
0/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Eye disorders
Extraocular muscle paresis
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Eye disorders
Eye disorders: eye lids twitching
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Eye disorders
Watering eyes
0.00%
0/6
28.6%
2/7
16.7%
1/6
16.7%
1/6
16.7%
1/6
28.6%
2/7
0.00%
0/18
Gastrointestinal disorders
Abdominal pain
16.7%
1/6
0.00%
0/7
0.00%
0/6
33.3%
2/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Gastrointestinal disorders
Anal mucositis
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Gastrointestinal disorders
Ascites
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Gastrointestinal disorders
Constipation
33.3%
2/6
71.4%
5/7
66.7%
4/6
50.0%
3/6
66.7%
4/6
42.9%
3/7
0.00%
0/18
Gastrointestinal disorders
Diarrhea
16.7%
1/6
57.1%
4/7
16.7%
1/6
50.0%
3/6
16.7%
1/6
42.9%
3/7
0.00%
0/18
Gastrointestinal disorders
Dry mouth
16.7%
1/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Gastrointestinal disorders
Dyspepsia
0.00%
0/6
0.00%
0/7
16.7%
1/6
33.3%
2/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Gastrointestinal disorders
Dysphagia
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Gastrointestinal disorders
Esophagitis
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Gastrointestinal disorders
Gastrointestinal disorders: inflamed gums
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Gastrointestinal disorders
Hemorrhoids
33.3%
2/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
16.7%
1/6
28.6%
2/7
0.00%
0/18
Gastrointestinal disorders
Mucositis oral
33.3%
2/6
42.9%
3/7
33.3%
2/6
50.0%
3/6
16.7%
1/6
42.9%
3/7
0.00%
0/18
Gastrointestinal disorders
Nausea
33.3%
2/6
28.6%
2/7
66.7%
4/6
33.3%
2/6
33.3%
2/6
42.9%
3/7
0.00%
0/18
Gastrointestinal disorders
Rectal hemorrhage
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Gastrointestinal disorders
Rectal pain
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Gastrointestinal disorders
Vomiting
50.0%
3/6
14.3%
1/7
50.0%
3/6
0.00%
0/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
General disorders
Edema face
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
General disorders
Edema limbs
33.3%
2/6
42.9%
3/7
16.7%
1/6
16.7%
1/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
General disorders
Edema trunk
33.3%
2/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
General disorders
Fatigue
33.3%
2/6
71.4%
5/7
83.3%
5/6
100.0%
6/6
83.3%
5/6
85.7%
6/7
0.00%
0/18
General disorders
Fever
16.7%
1/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
General disorders
General disorders and administration site conditions: cold intolerance
16.7%
1/6
28.6%
2/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
General disorders
Non-cardiac chest pain
0.00%
0/6
14.3%
1/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
General disorders
Pain
16.7%
1/6
14.3%
1/7
16.7%
1/6
33.3%
2/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Immune system disorders
Allergic reaction
0.00%
0/6
28.6%
2/7
16.7%
1/6
16.7%
1/6
0.00%
0/6
28.6%
2/7
0.00%
0/18
Infections and infestations
Infections and infestations: UTI
33.3%
2/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Infections and infestations
Lymph gland infection
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Infections and infestations
Urinary tract infection
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Infections and infestations
Vaginal infection
0.00%
0/6
14.3%
1/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Injury, poisoning and procedural complications
Bruising
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Investigations
Alanine aminotransferase increased
0.00%
0/6
14.3%
1/7
16.7%
1/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Investigations
Alkaline phosphatase increased
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Investigations
Aspartate aminotransferase increased
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Investigations
Neutrophil count decreased
16.7%
1/6
0.00%
0/7
50.0%
3/6
16.7%
1/6
33.3%
2/6
14.3%
1/7
0.00%
0/18
Investigations
Platelet count decreased
16.7%
1/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Investigations
Weight gain
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Investigations
Weight loss
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Investigations
White blood cell decreased
33.3%
2/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
33.3%
2/6
28.6%
2/7
0.00%
0/18
Metabolism and nutrition disorders
Acidosis
16.7%
1/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Metabolism and nutrition disorders
Anorexia
0.00%
0/6
28.6%
2/7
16.7%
1/6
83.3%
5/6
16.7%
1/6
71.4%
5/7
0.00%
0/18
Metabolism and nutrition disorders
Hyperglycemia
33.3%
2/6
28.6%
2/7
0.00%
0/6
33.3%
2/6
0.00%
0/6
57.1%
4/7
0.00%
0/18
Metabolism and nutrition disorders
Hyperkalemia
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Metabolism and nutrition disorders
Hypernatremia
16.7%
1/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Metabolism and nutrition disorders
Hypocalcemia
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Metabolism and nutrition disorders
Hypokalemia
16.7%
1/6
0.00%
0/7
33.3%
2/6
16.7%
1/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Metabolism and nutrition disorders
Hyponatremia
16.7%
1/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Arthralgia
33.3%
2/6
28.6%
2/7
50.0%
3/6
33.3%
2/6
0.00%
0/6
71.4%
5/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Back pain
66.7%
4/6
14.3%
1/7
0.00%
0/6
16.7%
1/6
16.7%
1/6
28.6%
2/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/6
14.3%
1/7
16.7%
1/6
16.7%
1/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Chest wall pain
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder : muscle tightness
0.00%
0/6
14.3%
1/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Myalgia
16.7%
1/6
28.6%
2/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
28.6%
2/7
0.00%
0/18
Musculoskeletal and connective tissue disorders
Pain in extremity
33.3%
2/6
28.6%
2/7
16.7%
1/6
16.7%
1/6
16.7%
1/6
28.6%
2/7
0.00%
0/18
Nervous system disorders
Ataxia
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Nervous system disorders
Dizziness
0.00%
0/6
28.6%
2/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
28.6%
2/7
0.00%
0/18
Nervous system disorders
Dysgeusia
50.0%
3/6
42.9%
3/7
33.3%
2/6
50.0%
3/6
0.00%
0/6
57.1%
4/7
0.00%
0/18
Nervous system disorders
Headache
83.3%
5/6
57.1%
4/7
83.3%
5/6
83.3%
5/6
66.7%
4/6
42.9%
3/7
0.00%
0/18
Nervous system disorders
Memory impairment
16.7%
1/6
14.3%
1/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Nervous system disorders
Peripheral sensory neuropathy
50.0%
3/6
42.9%
3/7
33.3%
2/6
16.7%
1/6
33.3%
2/6
57.1%
4/7
0.00%
0/18
Nervous system disorders
Sinus pain
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Nervous system disorders
Syncope
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Psychiatric disorders
Agitation
16.7%
1/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Psychiatric disorders
Anxiety
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
50.0%
3/6
14.3%
1/7
0.00%
0/18
Psychiatric disorders
Depression
16.7%
1/6
57.1%
4/7
0.00%
0/6
33.3%
2/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Psychiatric disorders
Insomnia
50.0%
3/6
57.1%
4/7
50.0%
3/6
66.7%
4/6
33.3%
2/6
57.1%
4/7
0.00%
0/18
Renal and urinary disorders
Cystitis noninfective
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Renal and urinary disorders
Urinary frequency
16.7%
1/6
0.00%
0/7
33.3%
2/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Renal and urinary disorders
Urinary tract pain
16.7%
1/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Reproductive system and breast disorders
Breast pain
33.3%
2/6
42.9%
3/7
16.7%
1/6
50.0%
3/6
50.0%
3/6
0.00%
0/7
5.6%
1/18
Reproductive system and breast disorders
Uterine pain
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Reproductive system and breast disorders
Vaginal discharge
0.00%
0/6
14.3%
1/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Reproductive system and breast disorders
Vaginal dryness
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Reproductive system and breast disorders
Vaginal pain
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
50.0%
3/6
28.6%
2/7
100.0%
6/6
50.0%
3/6
50.0%
3/6
42.9%
3/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Cough
50.0%
3/6
0.00%
0/7
33.3%
2/6
33.3%
2/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Dyspnea
16.7%
1/6
14.3%
1/7
50.0%
3/6
16.7%
1/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
28.6%
2/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders: dyspnea on exertion
0.00%
0/6
14.3%
1/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Sinus disorder
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Respiratory, thoracic and mediastinal disorders
Voice alteration
0.00%
0/6
14.3%
1/7
33.3%
2/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Alopecia
83.3%
5/6
71.4%
5/7
33.3%
2/6
33.3%
2/6
83.3%
5/6
28.6%
2/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
16.7%
1/6
0.00%
0/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Nail loss
16.7%
1/6
0.00%
0/7
33.3%
2/6
0.00%
0/6
16.7%
1/6
42.9%
3/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Pruritus
50.0%
3/6
14.3%
1/7
16.7%
1/6
16.7%
1/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/6
0.00%
0/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Rash acneiform
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/6
14.3%
1/7
0.00%
0/6
16.7%
1/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders: nose sores
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Skin and subcutaneous tissue disorders
Skin ulceration
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Vascular disorders
Flushing
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Vascular disorders
Hematoma
0.00%
0/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
14.3%
1/7
0.00%
0/18
Vascular disorders
Hot flashes
33.3%
2/6
42.9%
3/7
50.0%
3/6
16.7%
1/6
33.3%
2/6
42.9%
3/7
0.00%
0/18
Vascular disorders
Hypertension
16.7%
1/6
0.00%
0/7
0.00%
0/6
0.00%
0/6
16.7%
1/6
14.3%
1/7
0.00%
0/18
Vascular disorders
Vascular disorders: easy bruising
0.00%
0/6
0.00%
0/7
16.7%
1/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18
Vascular disorders
Vascular disorders: epitaxsis
0.00%
0/6
14.3%
1/7
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/7
0.00%
0/18

Additional Information

P. Kelly Marcom, M.D.

Duke University Medical Center

Phone: 919-684-3877

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place