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Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01705691
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
HER2-negative Breast Cancer
Interventions Drug: Paclitaxel
Drug: Eribulin
Drug: Doxorubicin
Drug: Cyclophosphamide
Enrollment 50
Recruitment Details  
Pre-assignment Details One patient randomly assigned to Arm 2 withdrew consent before receiving protocol therapy.
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
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Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Period Title: Overall Study
Started 19 30
Completed 16 24
Not Completed 3 6
Reason Not Completed
Death             1             2
Withdrawal by Subject             1             2
Lost to Follow-up             1             1
Other             0             1
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC Total
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Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Total of all reporting groups
Overall Number of Baseline Participants 19 30 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 30 participants 49 participants
50.47  (10.73) 49.17  (13.21) 49.67  (12.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 30 participants 49 participants
Female
19
 100.0%
30
 100.0%
49
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 30 participants 49 participants
White
13
  68.4%
24
  80.0%
37
  75.5%
Black or African American
4
  21.1%
4
  13.3%
8
  16.3%
Asian
1
   5.3%
1
   3.3%
2
   4.1%
Other
1
   5.3%
1
   3.3%
2
   4.1%
Not Hispanic or Latino
16
  84.2%
28
  93.3%
44
  89.8%
Hispanic or Latino
1
   5.3%
2
   6.7%
3
   6.1%
Unknown Ethnicity
2
  10.5%
0
   0.0%
2
   4.1%
1.Primary Outcome
Title Pathologic Complete Response Rate (ypCR) Following Neoadjuvant Therapy in Breast and Axillary Lymph Nodes
Hide Description Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes.
Time Frame At the time of surgery approximately 24 to 28 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient in Arm 1 was not analyzed due to inoperable, progressive disease. 2 patients in Arm 2 are missing data.
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description:

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Overall Number of Participants Analyzed 19 30
Measure Type: Number
Unit of Measure: percentage of participants
26.3 16.7
2.Secondary Outcome
Title ypCR Nodes
Hide Description Percentage of patients with no histologic evidence of cancer in axillary lymph nodes.
Time Frame At the time of surgery approximately 24 to 28 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient in Arm 1 was not analyzed due to inoperable, progressive disease. 2 patients in Arm 2 are missing data.
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description:

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Overall Number of Participants Analyzed 19 30
Measure Type: Number
Unit of Measure: percentage of participants
42.1 30.0
3.Secondary Outcome
Title Clinical Overall Response (cOR)(Complete and Partial) Assessed by MRI at the Completion of WP or Eribulin (Before AC)
Hide Description Percentage of patients with clinical complete response (no significant enhancement on MR images) or clinical partial response (at least 30% decrease in the maximal diameter of the tumor)
Time Frame 12 weeks after initiation of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description:

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Overall Number of Participants Analyzed 19 30
Measure Type: Number
Unit of Measure: percentage of participants
58 40
4.Secondary Outcome
Title Clinical Complete Response (ycCR) Following Neoadjuvant Therapy Assessed by Physical Exam at the Completion of Neoadjuvant Chemotherapy
Hide Description The number of patients with clinical complete response.
Time Frame At approximately 24 to 28 weeks from initiation of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient in Arm 1 and 3 patients in Arm 2 are missing data. The N=18 for the paclitaxel group is because analysis was done on only patients with a palpable lesion at baseline.
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description:

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Overall Number of Participants Analyzed 18 30
Measure Type: Number
Unit of Measure: participants
8 10
5.Secondary Outcome
Title Recurrence Free Interval (RFI): The Time to Occurrence of Inoperable Progressive Disease and Local, Regional, and Distant Recurrence.
Hide Description The percentage of patients free from recurrence at 24 months.
Time Frame Assessed through 24 months from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description:

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Overall Number of Participants Analyzed 19 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
83.6
(57.3 to 94.4)
80.7
(59.6 to 91.5)
6.Secondary Outcome
Title 2-year Overall Survival (OS): Death From Any Cause From Time of Randomization Through 2 Years After Randomization.
Hide Description Percentage of patients alive at 24 months.
Time Frame Assessed through 24 months from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description:

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Overall Number of Participants Analyzed 19 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
88.5
(61.4 to 97.0)
92.6
(73.5 to 98.1)
7.Secondary Outcome
Title Adverse Events Experienced by Participants as a Measure of Toxicity.
Hide Description Total patients with at least 1 AE.
Time Frame Assessed through 24 months from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Please refer to the AE section for more detail.
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description:

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Overall Number of Participants Analyzed 19 30
Measure Type: Number
Unit of Measure: participants
19 30
Time Frame Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Hide Arm/Group Description

Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles

Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles

Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles

Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles

All-Cause Mortality
Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Affected / at Risk (%) Affected / at Risk (%)
Total   3/19 (15.79%)   4/30 (13.33%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/19 (5.26%)  1/30 (3.33%) 
Gastrointestinal disorders     
Colitis  1  1/19 (5.26%)  0/30 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/19 (0.00%)  1/30 (3.33%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/19 (0.00%)  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/19 (5.26%)  0/30 (0.00%) 
Dyspnoea  1  0/19 (0.00%)  1/30 (3.33%) 
Vascular disorders     
Haematoma  1  0/19 (0.00%)  1/30 (3.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Paclitaxel Then AC Arm 2: Eribulin Then AC
Affected / at Risk (%) Affected / at Risk (%)
Total   19/19 (100.00%)   30/30 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  7/19 (36.84%)  16/30 (53.33%) 
Leukopenia  1  10/19 (52.63%)  11/30 (36.67%) 
Neutropenia  1  10/19 (52.63%)  11/30 (36.67%) 
Lymphopenia  1  4/19 (21.05%)  2/30 (6.67%) 
Febrile Neutropenia  1  1/19 (5.26%)  2/30 (6.67%) 
Cardiac disorders     
Palpitations  1  2/19 (10.53%)  3/30 (10.00%) 
Eye disorders     
Lacrimation increased  1  2/19 (10.53%)  1/30 (3.33%) 
Vision blurred  1  0/19 (0.00%)  2/30 (6.67%) 
Gastrointestinal disorders     
Nausea  1  10/19 (52.63%)  19/30 (63.33%) 
Constipation  1  5/19 (26.32%)  12/30 (40.00%) 
Diarrhoea  1  8/19 (42.11%)  4/30 (13.33%) 
Vomiting  1  4/19 (21.05%)  4/30 (13.33%) 
Dyspepsia  1  3/19 (15.79%)  4/30 (13.33%) 
Stomatitis  1  2/19 (10.53%)  5/30 (16.67%) 
Abdominal Pain  1  1/19 (5.26%)  3/30 (10.00%) 
Abdominal Pain Upper  1  0/19 (0.00%)  2/30 (6.67%) 
General disorders     
Fatigue  1  15/19 (78.95%)  22/30 (73.33%) 
Oedema peripheral  1  3/19 (15.79%)  1/30 (3.33%) 
Pain  1  3/19 (15.79%)  1/30 (3.33%) 
Pyrexia  1  2/19 (10.53%)  2/30 (6.67%) 
Axillary pain  1  1/19 (5.26%)  2/30 (6.67%) 
Chills  1  1/19 (5.26%)  2/30 (6.67%) 
Influenza like illness  1  1/19 (5.26%)  2/30 (6.67%) 
Mucosal inflammation  1  1/19 (5.26%)  2/30 (6.67%) 
Infections and infestations     
Urinary tract infection  1  3/19 (15.79%)  0/30 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  2/19 (10.53%)  15/30 (50.00%) 
Aspartate aminotransferase increased  1  1/19 (5.26%)  7/30 (23.33%) 
Blood alkaline phosphatase increased  1  1/19 (5.26%)  5/30 (16.67%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/19 (5.26%)  6/30 (20.00%) 
Hypernatraemia  1  1/19 (5.26%)  5/30 (16.67%) 
Hyperglycaemia  1  3/19 (15.79%)  2/30 (6.67%) 
Hypomagnesaemia  1  1/19 (5.26%)  3/30 (10.00%) 
Hypokalaemia  1  0/19 (0.00%)  4/30 (13.33%) 
Hypoalbuminaemia  1  2/19 (10.53%)  1/30 (3.33%) 
Hypoglycaemia  1  1/19 (5.26%)  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  2/19 (10.53%)  6/30 (20.00%) 
Pain in extremity  1  3/19 (15.79%)  4/30 (13.33%) 
Arthralgia  1  1/19 (5.26%)  4/30 (13.33%) 
Bone Pain  1  1/19 (5.26%)  4/30 (13.33%) 
Musculoskeletal pain  1  1/19 (5.26%)  2/30 (6.67%) 
Back pain  1  0/19 (0.00%)  2/30 (6.67%) 
Muscle spasms  1  0/19 (0.00%)  2/30 (6.67%) 
Nervous system disorders     
Headache  1  5/19 (26.32%)  12/30 (40.00%) 
Peripheral sensory neuropathy  1  6/19 (31.58%)  5/30 (16.67%) 
Dysgeusia  1  2/19 (10.53%)  7/30 (23.33%) 
Dizziness  1  3/19 (15.79%)  2/30 (6.67%) 
Paraesthesia  1  3/19 (15.79%)  2/30 (6.67%) 
Hypoaesthesia  1  1/19 (5.26%)  3/30 (10.00%) 
Neuropathy peripheral  1  1/19 (5.26%)  2/30 (6.67%) 
Psychiatric disorders     
Insomnia  1  4/19 (21.05%)  6/30 (20.00%) 
Anxiety  1  1/19 (5.26%)  6/30 (20.00%) 
Depression  1  0/19 (0.00%)  3/30 (10.00%) 
Renal and urinary disorders     
Dysuria  1  0/19 (0.00%)  2/30 (6.67%) 
Reproductive system and breast disorders     
Breast pain  1  3/19 (15.79%)  5/30 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/19 (21.05%)  6/30 (20.00%) 
Dyspnoea  1  2/19 (10.53%)  4/30 (13.33%) 
Dyspnoea exertional  1  2/19 (10.53%)  1/30 (3.33%) 
Oropharyngeal pain  1  2/19 (10.53%)  1/30 (3.33%) 
Nasal congestion  1  0/19 (0.00%)  3/30 (10.00%) 
Skin and subcutaneous tissue disorders     
Erythema  1  2/19 (10.53%)  2/30 (6.67%) 
Pruritus  1  2/19 (10.53%)  2/30 (6.67%) 
Nail discolouration  1  3/19 (15.79%)  0/30 (0.00%) 
Rash maculo-papular  1  0/19 (0.00%)  3/30 (10.00%) 
Acne  1  2/19 (10.53%)  0/30 (0.00%) 
Dry skin  1  0/19 (0.00%)  2/30 (6.67%) 
Rash  1  0/19 (0.00%)  2/30 (6.67%) 
Vascular disorders     
Hypertension  1  1/19 (5.26%)  4/30 (13.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Diana Gosik
Organization: NSABP Foundation, Inc.
Phone: 412-339-5333
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT01705691     History of Changes
Other Study ID Numbers: NSABP FB-9
First Submitted: October 8, 2012
First Posted: October 12, 2012
Results First Submitted: August 9, 2018
Results First Posted: September 18, 2018
Last Update Posted: September 18, 2018