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Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim (PROTECT2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516736
First Posted: January 25, 2012
Last Update Posted: August 30, 2017
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.
Collaborator:
Sandoz GmbH
Information provided by (Responsible Party):
Sandoz
Results First Submitted: March 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Chemotherapy-induced Neutropenia
Breast Cancer
Interventions: Drug: LA-EP2006
Drug: Neulasta®

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LA-EP2006

During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.

Neulasta®

During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.

Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.


Participant Flow:   Overall Study
    LA-EP2006   Neulasta®
STARTED [1]   155   153 
COMPLETED [2]   135   140 
NOT COMPLETED   20   13 
Withdrawal by Subject                10                4 
Adverse Event                4                5 
Death                3                1 
Physician Decision                2                1 
Lack of Efficacy                1                0 
Protocol Violation                0                1 
Other (not specified)                0                1 
[1] FAS/SAF full analysis set and safety analysis set
[2] 1 more patient, Neulasta arm died but been withdrawn earlier, not included in participant flow-death



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patient demographics (FAS set)

Reporting Groups
  Description
LA-EP2006

During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.

Neulasta®

During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.

Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Total Total of all reporting groups

Baseline Measures
   LA-EP2006   Neulasta®   Total 
Overall Participants Analyzed 
[Units: Participants]
 155   153   308 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
   48.8  (10.50)   49.1  (10.07)   48.9  (10.27) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
Female      155 100.0%      153 100.0%      308 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
Hispanic or Latino      10   6.5%      6   3.9%      16   5.2% 
Not Hispanic or Latino      145  93.5%      147  96.1%      292  94.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      62  40.0%      58  37.9%      120  39.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   0.6%      2   1.3%      3   1.0% 
White      90  58.1%      93  60.8%      183  59.4% 
More than one race      2   1.3%      0   0.0%      2   0.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
[1] The 2 patients with race “More than one race” were reported as Hispanic origin.
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
   26.56  (5.771)   26.49  (5.126)   26.53  (5.450) 
Time since diagnosis [1] 
[Units: Months]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 155   151   306 
   1.28 
 (0.2 to 42.3) 
 1.28 
 (0.3 to 11.2) 
 1.28 
 (0.2 to 42.3) 
[1] For 2 patients in the Neulasta treatment group, the date of initial diagnosis was incomplete.
Disease stage [1] 
[Units: Participants]
Count of Participants
     
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
 7   13   20 
II       
Participants Analyzed 
[Units: Participants]
 155   153   308 
II   70   61   131 
III       
Participants Analyzed 
[Units: Participants]
 155   153   308 
III   78   78   156 
IV       
Participants Analyzed 
[Units: Participants]
 155   153   308 
IV   0   1   1 
[1] TNM Disease stage was defined according to the American Joint Committee on Cancer (AJCC): (I) = T1 N0 M0 / T0 N1mi M0 / T1 N1mi M0; (II) = T0 N1 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0 / T3 N0 M0; (III) = T0 N2 M0 / T1 N2 M0 / T2 N2 M0 / T3 N1 M0 / T3 N2 M0 / T4 N0 M0 / T4 N1 M0 / T4 N2 M0 / AnyT N3 M0; (IV) = AnyT AnyN M1; T: size or direct extent of the primary tumour; N: degree of spread to regional lymph nodes; N1mi: Micrometastases (> 0.2 mm and/or > 200 cells, but none > 2.0 mm); M: presence of distant; https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#link/_27
Previous breast cancer surgery 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
   154   152   306 
Previous radiotherapy 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
   2   1   3 
ECOG performance status [1] 
[Units: Participants]
Count of Participants
     
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
 117   110   227 
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
 36   43   79 
     
Participants Analyzed 
[Units: Participants]
 155   153   308 
 2   0   2 
[1]

Grading according to ECOG:

0: Fully active, able to carry on all pre-disease performance without restriction 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2: Ambulatory and capable of all self-care but unable to carry out any work activities up and about more than 50% of waking hours 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy   [ Time Frame: 21 days (Cycle 1 of chemotherapy treatment) ]

2.  Secondary:   Incidence of Febrile Neutropenia (FN)   [ Time Frame: across all cycles (18 weeks) ]

3.  Secondary:   Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles   [ Time Frame: across al cycles (18 weeks) ]

4.  Secondary:   Depth of ANC Nadir in Cycle 1   [ Time Frame: Cycle 1 (3 weeks) ]

5.  Secondary:   Number of Patients With ANC Nadir Per Day in Cycle 1   [ Time Frame: Cycle 1 (3 weeks) ]

6.  Secondary:   Time to ANC Recovery in Days in Cycle 1   [ Time Frame: across Cycle 1 (3 weeks) ]

7.  Secondary:   Frequency of Infections by Cycle and Across All Cycles   [ Time Frame: across all cycles (18 weeks) ]

8.  Secondary:   Mortality Due to Infection   [ Time Frame: Study course (19 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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: Strategic Planning, Biopharmaceutical Clinical Development
Organization: Sandoz
phone: +49 (0) 8024 476 – 0
e-mail: biopharma.clinicaltrials@sandoz.com


Publications:

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01516736     History of Changes
Other Study ID Numbers: LA-EP06-302
First Submitted: January 13, 2012
First Posted: January 25, 2012
Results First Submitted: March 28, 2017
Results First Posted: June 28, 2017
Last Update Posted: August 30, 2017