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Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in 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: NCT01527487
Recruitment Status : Completed
First Posted : February 7, 2012
Results First Posted : August 26, 2016
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HER2 Negative Breast Cancer
Interventions Drug: Eribulin
Drug: Cyclophosphamide
Drug: Docetaxel
Enrollment 76
Recruitment Details This neoadjuvant trial evaluated the combination of eribulin/cyclophosphamide (ErC) versus docetaxel/cyclophosphamide (TC) in women with clinical stage II-III breast cancers. Between JUN 2012 and APR 2014, 76 patients were enrolled.
Pre-assignment Details After a 10-patient lead-in to confirm safety and feasibility of ErC, subsequent patients (66) were randomized 2 to 1 for treatment with: (1) ErC (44 patients) or (2) TC (22 patients). Both regimens were administered every 21 days for 6 cycles followed by surgery.
Arm/Group Title Eribulin+Cyclophosphamide: ErC Docetaxel+Cyclophosphamide: TC
Hide Arm/Group Description

Eribulin (Er): 1.4 mg/m^2 by IV infusion (Days 1 and 8); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)

Administered every 21 days for 6 cycles followed by surgery.

Docetaxel (T): 75 mg/m^2 by IV infusion (Day 1); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)tandard.

Administered every 21 days for 6 cycles followed by surgery.

Period Title: Overall Study
Started 54 [1] 22
Completed 46 [2] 15
Not Completed 8 7
Reason Not Completed
MD Discretion/Lack of Efficacy             3             4
Disease Progression             4             1
Adverse Event             1             1
Death             0             1
[1]
Includes 10 patients from safety lead-in.
[2]
Patients who completed 6 cycles plus surgery.
Arm/Group Title Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC) Total
Hide Arm/Group Description

Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard;

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion;

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Total of all reporting groups
Overall Number of Baseline Participants 54 22 76
Hide Baseline Analysis Population Description
Analysis population for ErC includes 10 lead-in and 44 randomized patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 54 participants 22 participants 76 participants
53
(23 to 77)
51
(38 to 73)
52
(23 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 22 participants 76 participants
Female
54
 100.0%
22
 100.0%
76
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants 22 participants 76 participants
54 22 76
1.Primary Outcome
Title Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery
Hide Description One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist.
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed 6 cycles and proceeded to surgery.
Arm/Group Title Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Hide Arm/Group Description:

Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion

Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion

Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion

Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)

Overall Number of Participants Analyzed 39 20
Measure Type: Number
Unit of Measure: percentage of surgical patients
18 10
2.Secondary Outcome
Title The Number of Adverse Events as a Measure of Safety and Tolerability.
Hide Description Treatment-Related Adverse Events occurring in >= 15% of treated patients
Time Frame 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Hide Arm/Group Description:

Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.

Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.

Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.

Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.

Overall Number of Participants Analyzed 54 22
Measure Type: Number
Unit of Measure: participants
Fatigue 32 14
Alopecia 25 14
Nausea 26 8
Peripheral Sensory Neuropathy 18 10
Neutrophil Count Decreased 21 6
Constipation 15 6
Diarrhea 11 10
Anemia 12 8
Headache 9 4
Dysgeusia 8 5
White Blood Cell Decreased 8 5
Myalgia 7 6
Hot Flashes 7 3
Mucositis 5 5
Arthralgia 2 8
Edema Limbs 2 8
3.Secondary Outcome
Title Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy
Hide Description Defined as the number of patients with a best response of clinical complete or partial response (cCR or cPR) divided by the number of patients qualified for tumor response analysis per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI or CT. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD;
Time Frame 43 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients evaluated/evaluable per RECIST v1.1
Arm/Group Title Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Hide Arm/Group Description:

Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.

Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion.

Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.

Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.

Overall Number of Participants Analyzed 34 17
Measure Type: Number
Unit of Measure: percentage of participants
67.6 64.7
4.Secondary Outcome
Title Disease-Free Survival (DFS) at 2 Years
Hide Description Defined as the percent probability that participants had not experienced disease recurrence or died from any cause at 2 years post-surgery, analyzed by Kaplan-Meier methodology.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients that completed surgery.
Arm/Group Title Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Hide Arm/Group Description:

Eribulin (Er): 1.4mg/m^2 IV (Days 1 and 8 of each treatment cycle) by IV infusion.

Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle by IV infusion.

Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.

Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks.

Overall Number of Participants Analyzed 53 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability of survival
82.35
(60.15 to 92.85)
89.06
(62.66 to 97.17)
Time Frame 43 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Hide Arm/Group Description

Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Eribulin: 1.4 mg/m2 IV (Days 1 & 8), given short (≤15 minute) IV infusion, per institutional standard

Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.

Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion

Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard

Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.

Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks.

All-Cause Mortality
Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/54 (7.41%)   2/22 (9.09%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  1  3/54 (5.56%)  1/22 (4.55%) 
Infections and infestations     
Sepsis  1  1/54 (1.85%)  1/22 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eribulin+Cyclophosphamide (ErC) Docetaxel+Cyclophosphamide (TC)
Affected / at Risk (%) Affected / at Risk (%)
Total   44/54 (81.48%)   22/22 (100.00%) 
Blood and lymphatic system disorders     
ANEMIA  1  18/54 (33.33%)  8/22 (36.36%) 
FEBRILE NEUTROPENIA  1  3/54 (5.56%)  0/22 (0.00%) 
LEUKOPENIA  1  15/54 (27.78%)  5/22 (22.73%) 
NEUTROPENIA  1  26/54 (48.15%)  5/22 (22.73%) 
THROMBOCYTOPENIA  1  3/54 (5.56%)  1/22 (4.55%) 
Eye disorders     
WATERING EYES  1  2/54 (3.70%)  2/22 (9.09%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  6/54 (11.11%)  0/22 (0.00%) 
CONSTIPATION  1  16/54 (29.63%)  6/22 (27.27%) 
DIARRHEA  1  12/54 (22.22%)  10/22 (45.45%) 
DYSPEPSIA  1  9/54 (16.67%)  0/22 (0.00%) 
MUCOSITIS  1  6/54 (11.11%)  5/22 (22.73%) 
NAUSEA  1  33/54 (61.11%)  8/22 (36.36%) 
VOMITING  1  3/54 (5.56%)  0/22 (0.00%) 
General disorders     
ASTHENIA  1  4/54 (7.41%)  1/22 (4.55%) 
CHILLS  1  3/54 (5.56%)  0/22 (0.00%) 
EDEMA  1  3/54 (5.56%)  8/22 (36.36%) 
FATIGUE  1  40/54 (74.07%)  14/22 (63.64%) 
FEVER  1  6/54 (11.11%)  1/22 (4.55%) 
HOT FLASHES  1  9/54 (16.67%)  3/22 (13.64%) 
MALAISE  1  3/54 (5.56%)  0/22 (0.00%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  3/54 (5.56%)  0/22 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/54 (5.56%)  0/22 (0.00%) 
LYMPHOCYTE COUNT DECREASED  1  3/54 (5.56%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
ANOREXIA  1  3/54 (5.56%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  2/54 (3.70%)  8/22 (36.36%) 
MYALGIA  1  9/54 (16.67%)  6/22 (27.27%) 
Nervous system disorders     
DIZZINESS  1  5/54 (9.26%)  2/22 (9.09%) 
DYSGEUSIA  1  7/54 (12.96%)  4/22 (18.18%) 
HEADACHE  1  11/54 (20.37%)  4/22 (18.18%) 
INSOMNIA  1  5/54 (9.26%)  3/22 (13.64%) 
PARESTHESIA  1  5/54 (9.26%)  0/22 (0.00%) 
PERIPHERAL NEUROPATHY  1  19/54 (35.19%)  10/22 (45.45%) 
TASTE ALTERATION  1  5/54 (9.26%)  1/22 (4.55%) 
Renal and urinary disorders     
URINARY TRACT INFECTION  1  3/54 (5.56%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNEA  1  4/54 (7.41%)  2/22 (9.09%) 
POST NASAL DRIP  1  3/54 (5.56%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders     
ALOPECIA  1  32/54 (59.26%)  14/22 (63.64%) 
DRY SKIN  1  3/54 (5.56%)  0/22 (0.00%) 
NAIL CHANGES  1  2/54 (3.70%)  2/22 (9.09%) 
NAIL DISCOLORATION  1  1/54 (1.85%)  3/22 (13.64%) 
PRURITUS  1  3/54 (5.56%)  0/22 (0.00%) 
RASH  1  5/54 (9.26%)  2/22 (9.09%) 
SCALP PAIN  1  0/54 (0.00%)  2/22 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01527487    
Other Study ID Numbers: SCRI BRE 197
First Submitted: January 31, 2012
First Posted: February 7, 2012
Results First Submitted: March 18, 2016
Results First Posted: August 26, 2016
Last Update Posted: November 4, 2016