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Eribulin in HER2 Negative Metastatic BrCa

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ClinicalTrials.gov Identifier: NCT01827787
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Erica Mayer, MD, MPH, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Eribulin
Enrollment 83
Recruitment Details Participants were enrolled between May 2013 and March 2016.
Pre-assignment Details  
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC
Hide Arm/Group Description

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Period Title: Overall Study
Started 45 38
Completed 45 38
Not Completed 0 0
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC Total
Hide Arm/Group Description

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Total of all reporting groups
Overall Number of Baseline Participants 45 38 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 38 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
  77.8%
33
  86.8%
68
  81.9%
>=65 years
10
  22.2%
5
  13.2%
15
  18.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 38 participants 83 participants
59
(34 to 87)
53
(38 to 76)
56
(34 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 38 participants 83 participants
Female
45
 100.0%
38
 100.0%
83
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 38 participants 83 participants
Hispanic or Latino
41
  91.1%
35
  92.1%
76
  91.6%
Not Hispanic or Latino
1
   2.2%
1
   2.6%
2
   2.4%
Unknown or Not Reported
3
   6.7%
2
   5.3%
5
   6.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 38 participants 83 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
   7.9%
3
   3.6%
White
42
  93.3%
34
  89.5%
76
  91.6%
More than one race
1
   2.2%
0
   0.0%
1
   1.2%
Unknown or Not Reported
2
   4.4%
1
   2.6%
3
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 38 participants 83 participants
45 38 83
Eastern Cooperative Oncology Group Performance Score (ECOG PS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 38 participants 83 participants
ECOG PS0
33
  73.3%
26
  68.4%
59
  71.1%
ECOG PS1
11
  24.4%
12
  31.6%
23
  27.7%
ECOG PS2
1
   2.2%
0
   0.0%
1
   1.2%
[1]
Measure Description: ECOG PS0: Fully active, able to carry on all pre-disease performance without restriction ECOG PS1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG PS2: Ambulatory and capable of all self-care but unable to carry out any work activities; Up and about more than 50% of waking hours
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time Frame Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 45 38
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
35.6
(24 to 49)
13.2
(5 to 26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: HR+/HER2-
Comments

Using a one sample binomial design, with 45 patients there was 90% power to detect a null hypothesis 30% overall response rate (historical control) versus an alternative hypothesis of 53% overall response rate assuming a two-sided 10% alpha.

Of note, cohort 2: TNBC did not fully accrue 45 patients so a testing was not done.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Time Frame Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) PFS follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled participants.
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 45 38
Mean (90% Confidence Interval)
Unit of Measure: months
6.2
(5.9 to 8.7)
4.0
(3.5 to 4.8)
3.Secondary Outcome
Title Time to First Response (TTR)
Hide Description TTR is defined as the time from first dose of study treatment until the earliest date that complete response (CR) or partial response (PR) based on RECIST 1.1 criteria is objectively documented. Non-CR, non-PR participants are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response requires 4 week or later confirmation and assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time Frame Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled participants.
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 45 38
Median (Full Range)
Unit of Measure: months
10.6
(1.7 to 14.9)
NA [1] 
(1.9 to 4.3)
[1]
Median was not reached.
4.Secondary Outcome
Title Duration of Overall Response (DOR)
Hide Description DOR is defined as the that response criteria for CR or PR (whichever is recorded first) are first met until the date that PD or death from any cause is first objectively documented. Participants who do not have PD will be censored on date of last disease assessment.
Time Frame Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) DOR follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all enrolled participants.
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 45 38
Median (Full Range)
Unit of Measure: months
6.5
(1.8 to 12.3)
1.9
(1.3 to 4.1)
5.Secondary Outcome
Title Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Sensory Neuropathy
Hide Description The percentage of treated participants experiencing grade 1-3 peripheral sensory neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.
Time Frame Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all treated participants. Per protocol, the cohorts were combined for this analysis.
Arm/Group Title Combined Cohort 1: HR+/HER2- and Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 83
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
36.1
(27.4 to 45.7)
6.Secondary Outcome
Title Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Motor Neuropathy
Hide Description TThe percentage of treated participants experiencing grade 1-3 peripheral motor neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.
Time Frame Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all treated participants.Per protocol, the cohorts were combined for this analysis.
Arm/Group Title Combined Cohort 1: HR+/HER2- and Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 83
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
22.9
(15.5 to 31.7)
7.Secondary Outcome
Title Functional Assessment of Cancer Therapy-Breast Cancer Subscale (FACT-BCS) Change Score From Baseline
Hide Description The FACT-BCS is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to breast cancer patients. (Brady MJ, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. JCO 1997; 15:974-86). The FACT-BCS has 9-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 36. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.
Time Frame Assessed at baseline and on treatment day 1 of cycles 2, 3, 5, 7, 9 and 11
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all participants who completed both QOL assessments required to calculate change from baseline. Per protocol, the cohorts were combined for this analysis.
Arm/Group Title Combined Group (Hormone Receptor Positive and Triple Negative)
Hide Arm/Group Description:

Eribulin Monotherapy

Eribulin: Intravenously on Day 1 and 8 of each cycle

Overall Number of Participants Analyzed 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 2 Change from Baseline Number Analyzed 43 participants
1.0  (4.6)
Cycle 3 Change from Baseline Number Analyzed 40 participants
0.6  (5.1)
Cycle 5 Change from Baseline Number Analyzed 26 participants
0.1  (4.4)
Cycle 7 Change from Baseline Number Analyzed 18 participants
0.6  (3.2)
Cycle 9 Change from Baseline Number Analyzed 13 participants
1.8  (5.0)
Cycle 11 Change from Baseline Number Analyzed 9 participants
1.1  (2.9)
8.Secondary Outcome
Title Functional Assessment of Cancer Therapy-Neurotoxicity Subscale (FACT-Ntx) Change Score From Baseline
Hide Description The FACT-Ntx is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to patients suffering from neurotoxicity. (Calhoun EA, et al. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer 2003; 13:741-8). The FACT-Ntx has 11-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 44. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.
Time Frame Assessed at baseline and on treatment day 1 of cycles 2, 3, 5, 7, 9 and 11
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all participants who completed both QOL assessments required to calculate change from baseline. Per protocol, the cohorts were combined for this analysis.
Arm/Group Title Combine Cohort 1: HR+/HER2- and Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cycle 2 Change from Baseline -0.1  (3.0)
Cycle 3 Change from Baseline -0.3  (4.7)
Cycle 5 Change from Baseline -1.6  (5.5)
Cycle 7 Change from Baseline -4.5  (6.4)
Cycle 9 Change from Baseline -1.8  (5.9)
Cycle 11 Change from Baseline -1.6  (4.7)
9.Post-Hoc Outcome
Title Overall Survival
Hide Description OS based on Kaplan-Meier is defined as the time from study entry to death or censored at date last known alive.
Time Frame Overall median survival follow-up was 5.9 months including a maximum of 27 months for Cohort 1 and 15 months for Cohort 2.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC
Hide Arm/Group Description:

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Overall Number of Participants Analyzed 45 38
Median (90% Confidence Interval)
Unit of Measure: months
20 [1] 
(20 to NA)
11.3 [1] 
(9.1 to NA)
[1]
Follow-up is not long enough/Data is not mature to provide upper bound 90% CI.
Time Frame Adverse events (AEs) were assessed every cycle on treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2).
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
 
Arm/Group Title Cohort 1: HR+/HER2- Cohort 2: TNBC
Hide Arm/Group Description

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

All-Cause Mortality
Cohort 1: HR+/HER2- Cohort 2: TNBC
Affected / at Risk (%) Affected / at Risk (%)
Total   4/45 (8.89%)   9/38 (23.68%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: HR+/HER2- Cohort 2: TNBC
Affected / at Risk (%) Affected / at Risk (%)
Total   22/45 (48.89%)   13/38 (34.21%) 
Blood and lymphatic system disorders     
Anemia  1  0/45 (0.00%)  2/38 (5.26%) 
Febrile neutropenia  1  2/45 (4.44%)  2/38 (5.26%) 
Gastrointestinal disorders     
Diarrhea  1  1/45 (2.22%)  1/38 (2.63%) 
Mucositis oral  1  1/45 (2.22%)  0/38 (0.00%) 
Nausea  1  0/45 (0.00%)  1/38 (2.63%) 
Vomiting  1  1/45 (2.22%)  2/38 (5.26%) 
General disorders     
Fatigue  1  1/45 (2.22%)  0/38 (0.00%) 
Infections and infestations     
Lip infection  1  0/45 (0.00%)  1/38 (2.63%) 
Investigations     
Alkaline phosphatase increased  1  1/45 (2.22%)  0/38 (0.00%) 
Aspartate aminotransferase increased  1  1/45 (2.22%)  0/38 (0.00%) 
Lymphocyte count decreased  1  1/45 (2.22%)  0/38 (0.00%) 
Neutrophil count decreased  1  16/45 (35.56%)  4/38 (10.53%) 
White blood cell decreased  1  2/45 (4.44%)  1/38 (2.63%) 
Metabolism and nutrition disorders     
Dehydration  1  1/45 (2.22%)  0/38 (0.00%) 
Nervous system disorders     
Peripheral motor neuropathy  1  3/45 (6.67%)  0/38 (0.00%) 
Peripheral sensory neuropathy  1  2/45 (4.44%)  2/38 (5.26%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  2/45 (4.44%)  0/38 (0.00%) 
Vascular disorders     
Thromboembolic event  1  0/45 (0.00%)  1/38 (2.63%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: HR+/HER2- Cohort 2: TNBC
Affected / at Risk (%) Affected / at Risk (%)
Total   45/45 (100.00%)   37/38 (97.37%) 
Blood and lymphatic system disorders     
Anemia  1  9/45 (20.00%)  6/38 (15.79%) 
Febrile neutropenia  1  1/45 (2.22%)  0/38 (0.00%) 
Cardiac disorders     
Chest pain - cardiac  1  1/45 (2.22%)  1/38 (2.63%) 
Palpitations  1  0/45 (0.00%)  1/38 (2.63%) 
Sinus tachycardia  1  1/45 (2.22%)  0/38 (0.00%) 
Ear and labyrinth disorders     
Ear and labyrinth disorders - Other  1  1/45 (2.22%)  0/38 (0.00%) 
Ear pain  1  2/45 (4.44%)  0/38 (0.00%) 
Vertigo  1  2/45 (4.44%)  0/38 (0.00%) 
Eye disorders     
Blurred vision  1  1/45 (2.22%)  0/38 (0.00%) 
Cataract  1  1/45 (2.22%)  0/38 (0.00%) 
Conjunctivitis  1  1/45 (2.22%)  0/38 (0.00%) 
Eye disorders - Other  1  2/45 (4.44%)  1/38 (2.63%) 
Watering eyes  1  3/45 (6.67%)  1/38 (2.63%) 
Gastrointestinal disorders     
Abdominal distension  1  0/45 (0.00%)  1/38 (2.63%) 
Abdominal pain  1  2/45 (4.44%)  2/38 (5.26%) 
Colonic perforation  1  0/45 (0.00%)  1/38 (2.63%) 
Constipation  1  9/45 (20.00%)  12/38 (31.58%) 
Diarrhea  1  10/45 (22.22%)  4/38 (10.53%) 
Dry mouth  1  10/45 (22.22%)  3/38 (7.89%) 
Duodenal ulcer  1  1/45 (2.22%)  0/38 (0.00%) 
Dyspepsia  1  3/45 (6.67%)  3/38 (7.89%) 
Dysphagia  1  3/45 (6.67%)  0/38 (0.00%) 
Esophagitis  1  1/45 (2.22%)  0/38 (0.00%) 
Gastroesophageal reflux disease  1  4/45 (8.89%)  3/38 (7.89%) 
Gastrointestinal disorders - Other  1  2/45 (4.44%)  2/38 (5.26%) 
Mucositis oral  1  12/45 (26.67%)  5/38 (13.16%) 
Nausea  1  17/45 (37.78%)  17/38 (44.74%) 
Oral pain  1  3/45 (6.67%)  1/38 (2.63%) 
Rectal hemorrhage  1  0/45 (0.00%)  1/38 (2.63%) 
Stomach pain  1  1/45 (2.22%)  0/38 (0.00%) 
Toothache  1  1/45 (2.22%)  0/38 (0.00%) 
Vomiting  1  8/45 (17.78%)  7/38 (18.42%) 
General disorders     
Chills  1  1/45 (2.22%)  1/38 (2.63%) 
Edema limbs  1  3/45 (6.67%)  3/38 (7.89%) 
Fatigue  1  29/45 (64.44%)  25/38 (65.79%) 
Fever  1  4/45 (8.89%)  2/38 (5.26%) 
Flu like symptoms  1  1/45 (2.22%)  1/38 (2.63%) 
Gait disturbance  1  0/45 (0.00%)  1/38 (2.63%) 
General disorders and administration site conditions - Other  1  0/45 (0.00%)  0/38 (0.00%) 
Infusion site extravasation  1  0/45 (0.00%)  1/38 (2.63%) 
Non-cardiac chest pain  1  2/45 (4.44%)  1/38 (2.63%) 
Pain  1  12/45 (26.67%)  6/38 (15.79%) 
Hepatobiliary disorders     
Hepatobiliary disorders - Other  1  1/45 (2.22%)  0/38 (0.00%) 
Infections and infestations     
Breast infection  1  1/45 (2.22%)  0/38 (0.00%) 
Gum infection  1  1/45 (2.22%)  0/38 (0.00%) 
Infections and infestations - Other  1  1/45 (2.22%)  1/38 (2.63%) 
Lung infection  1  0/45 (0.00%)  1/38 (2.63%) 
Sinusitis  1  1/45 (2.22%)  0/38 (0.00%) 
Skin infection  1  1/45 (2.22%)  0/38 (0.00%) 
Tooth infection  1  2/45 (4.44%)  0/38 (0.00%) 
Upper respiratory infection  1  1/45 (2.22%)  3/38 (7.89%) 
Urinary tract infection  1  7/45 (15.56%)  3/38 (7.89%) 
Vaginal infection  1  0/45 (0.00%)  1/38 (2.63%) 
Injury, poisoning and procedural complications     
Venous injury  1  1/45 (2.22%)  0/38 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  8/45 (17.78%)  4/38 (10.53%) 
Alkaline phosphatase increased  1  4/45 (8.89%)  3/38 (7.89%) 
Aspartate aminotransferase increased  1  9/45 (20.00%)  3/38 (7.89%) 
Blood bilirubin increased  1  0/45 (0.00%)  1/38 (2.63%) 
CD4 lymphocytes decreased  1  1/45 (2.22%)  0/38 (0.00%) 
Investigations - Other  1  2/45 (4.44%)  1/38 (2.63%) 
Lymphocyte count decreased  1  1/45 (2.22%)  0/38 (0.00%) 
Neutrophil count decreased  1  2/45 (4.44%)  5/38 (13.16%) 
Platelet count decreased  1  3/45 (6.67%)  3/38 (7.89%) 
Weight loss  1  3/45 (6.67%)  2/38 (5.26%) 
White blood cell decreased  1  4/45 (8.89%)  2/38 (5.26%) 
Metabolism and nutrition disorders     
Anorexia  1  11/45 (24.44%)  6/38 (15.79%) 
Dehydration  1  1/45 (2.22%)  1/38 (2.63%) 
Hypercalcemia  1  0/45 (0.00%)  1/38 (2.63%) 
Hyperglycemia  1  5/45 (11.11%)  1/38 (2.63%) 
Hyperkalemia  1  1/45 (2.22%)  0/38 (0.00%) 
Hypoalbuminemia  1  3/45 (6.67%)  1/38 (2.63%) 
Hypocalcemia  1  2/45 (4.44%)  0/38 (0.00%) 
Hypoglycemia  1  1/45 (2.22%)  0/38 (0.00%) 
Hypokalemia  1  2/45 (4.44%)  4/38 (10.53%) 
Hypomagnesemia  1  3/45 (6.67%)  1/38 (2.63%) 
Hyponatremia  1  2/45 (4.44%)  0/38 (0.00%) 
Metabolism and nutrition disorders - Other  1  0/45 (0.00%)  1/38 (2.63%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/45 (17.78%)  4/38 (10.53%) 
Back pain  1  1/45 (2.22%)  5/38 (13.16%) 
Bone pain  1  5/45 (11.11%)  3/38 (7.89%) 
Buttock pain  1  1/45 (2.22%)  0/38 (0.00%) 
Chest wall pain  1  2/45 (4.44%)  2/38 (5.26%) 
Flank pain  1  1/45 (2.22%)  0/38 (0.00%) 
Generalized muscle weakness  1  0/45 (0.00%)  3/38 (7.89%) 
Joint effusion  1  0/45 (0.00%)  1/38 (2.63%) 
Muscle weakness lower limb  1  2/45 (4.44%)  0/38 (0.00%) 
Muscle weakness right-sided  1  1/45 (2.22%)  0/38 (0.00%) 
Muscle weakness upper limb  1  0/45 (0.00%)  1/38 (2.63%) 
Musculoskeletal and connective tissue disorder - Other  1  3/45 (6.67%)  1/38 (2.63%) 
Myalgia  1  8/45 (17.78%)  5/38 (13.16%) 
Neck pain  1  1/45 (2.22%)  2/38 (5.26%) 
Pain in extremity  1  5/45 (11.11%)  2/38 (5.26%) 
Nervous system disorders     
Concentration impairment  1  8/45 (17.78%)  0/38 (0.00%) 
Dizziness  1  3/45 (6.67%)  3/38 (7.89%) 
Dysgeusia  1  6/45 (13.33%)  2/38 (5.26%) 
Facial nerve disorder  1  0/45 (0.00%)  1/38 (2.63%) 
Headache  1  7/45 (15.56%)  3/38 (7.89%) 
Memory impairment  1  0/45 (0.00%)  1/38 (2.63%) 
Movements involuntary  1  0/45 (0.00%)  1/38 (2.63%) 
Nervous system disorders - Other  1  2/45 (4.44%)  0/38 (0.00%) 
Paresthesia  1  1/45 (2.22%)  2/38 (5.26%) 
Peripheral motor neuropathy  1  12/45 (26.67%)  5/38 (13.16%) 
Peripheral sensory neuropathy  1  17/45 (37.78%)  9/38 (23.68%) 
Psychiatric disorders     
Anxiety  1  6/45 (13.33%)  4/38 (10.53%) 
Depression  1  3/45 (6.67%)  3/38 (7.89%) 
Insomnia  1  2/45 (4.44%)  4/38 (10.53%) 
Renal and urinary disorders     
Hematuria  1  0/45 (0.00%)  1/38 (2.63%) 
Urinary urgency  1  1/45 (2.22%)  0/38 (0.00%) 
Reproductive system and breast disorders     
Breast pain  1  2/45 (4.44%)  2/38 (5.26%) 
Vaginal hemorrhage  1  1/45 (2.22%)  0/38 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  11/45 (24.44%)  2/38 (5.26%) 
Dyspnea  1  14/45 (31.11%)  5/38 (13.16%) 
Epistaxis  1  1/45 (2.22%)  0/38 (0.00%) 
Hoarseness  1  2/45 (4.44%)  0/38 (0.00%) 
Pleural effusion  1  2/45 (4.44%)  1/38 (2.63%) 
Pleuritic pain  1  0/45 (0.00%)  1/38 (2.63%) 
Pneumonitis  1  2/45 (4.44%)  0/38 (0.00%) 
Postnasal drip  1  0/45 (0.00%)  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders - Other  1  3/45 (6.67%)  0/38 (0.00%) 
Sinus disorder  1  1/45 (2.22%)  0/38 (0.00%) 
Sore throat  1  0/45 (0.00%)  3/38 (7.89%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  26/45 (57.78%)  15/38 (39.47%) 
Dry skin  1  4/45 (8.89%)  1/38 (2.63%) 
Pruritus  1  1/45 (2.22%)  0/38 (0.00%) 
Rash maculo-papular  1  5/45 (11.11%)  1/38 (2.63%) 
Rash maculo-papular  1  0/45 (0.00%)  0/38 (0.00%) 
Skin and subcutaneous tissue disorders - Other  1  2/45 (4.44%)  0/38 (0.00%) 
Skin hyperpigmentation  1  0/45 (0.00%)  1/38 (2.63%) 
Urticaria  1  0/45 (0.00%)  1/38 (2.63%) 
Vascular disorders     
Hot flashes  1  1/45 (2.22%)  3/38 (7.89%) 
Hypertension  1  1/45 (2.22%)  3/38 (7.89%) 
Lymphedema  1  0/45 (0.00%)  1/38 (2.63%) 
Thromboembolic event  1  1/45 (2.22%)  0/38 (0.00%) 
Vascular disorders - Other  1  0/45 (0.00%)  1/38 (2.63%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
The study terminated early with cohort 2: TNBC not meeting target accrual of 45 patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Erica Mayer
Organization: Dana-Farber Cancer Institute
Phone: 617-632-2335
Responsible Party: Erica Mayer, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01827787     History of Changes
Other Study ID Numbers: 13-077
First Submitted: April 3, 2013
First Posted: April 10, 2013
Results First Submitted: July 27, 2018
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019