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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01516736
First received: January 13, 2012
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.


Condition Intervention Phase
Chemotherapy-induced Neutropenia
Breast Cancer
Drug: LA-EP2006
Drug: Peg-Filgrastim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy [ Time Frame: 21 days (Cycle 1 of chemotherapy treatment) ] [ Designated as safety issue: Yes ]
    Mean duration of severe neutropenia, defined as number of consecutive days with Grade 4 neutropenia.


Secondary Outcome Measures:
  • Incidence of febrile neutropenia [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    to assess the safety of LA-EP2006 and Peg-Filgrastim

  • Incidence, occurrence and severity of (serious) adverse events. [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 308
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LA-EP2006
During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
Drug: LA-EP2006
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.
Active Comparator: Peg-Filgrastim
During each chemotherapy cycle eligible patients receive Peg-Filgrastim s.c. post chemotherapy application.
Drug: Peg-Filgrastim
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically proven breast cancer
  • eligible for six cycles of neoadjuvant or adjuvant chemotherapy

Exclusion Criteria:

  • concurrent or prior chemotherapy for breast cancer
  • concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
  • concurrent prophylactic antibiotics
  • previous therapy with any G-CSF (granulocyte-colony stimulating factor) product

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516736

Locations
United States, Arkansas
Sandoz Investigational Site
Hot Springs, Arkansas, United States, 71913
Sandoz Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
Sandoz Investigational Site
Corona, California, United States, 92879
Sandoz Investigational Site
Fountain Valley, California, United States, 92708
Sandoz Investigational Site
Riverside, California, United States, 92507
United States, Florida
Sandoz Investigational Site
Miami, Florida, United States, 33133
United States, Illinois
Sandoz Investigational Site
Evergreen Park, Illinois, United States, 60805
Sandoz Investigational Site
Park Ridge, Illinois, United States, 60068
Sandoz Investigational Site
Skokie, Illinois, United States, 60076
United States, Kansas
Sandoz Investigational Site
Wichita, Kansas, United States, 67214
United States, Kentucky
Sandoz Investigational Site
Mt Sterling, Kentucky, United States, 40353
United States, Maryland
Sandoz Investigational Site
Bethesda, Maryland, United States, 20817
United States, Michigan
Sandoz Investigational Site
Detroit, Michigan, United States, 48202
United States, North Dakota
Sandoz Investigational Site
Bismarck, North Dakota, United States, 58501
United States, Oregon
Sandoz Investigational Site
Eugene, Oregon, United States, 97401
United States, Tennessee
Sandoz Investigational Site
Germantown, Tennessee, United States, 38138
United States, Virginia
Sandoz Investigational Site
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
Sandoz
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01516736     History of Changes
Other Study ID Numbers: LA-EP06-302
Study First Received: January 13, 2012
Last Updated: February 21, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Sandoz:
Pegfilgrastim
G-CSF
neutropenia
breast cancer
myelosuppressive chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014