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

This study is currently recruiting participants.
Verified January 2012 by Sandoz
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01516736
First received: January 13, 2012
Last updated: November 21, 2012
Last verified: January 2012
History of Changes

January 13, 2012
November 21, 2012
December 2011
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01516736 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Chemotherapy-induced Neutropenia
  • Breast Cancer
  • 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.
  • 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.
  • Experimental: LA-EP2006
    During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
    Intervention: Drug: LA-EP2006
  • Active Comparator: Peg-Filgrastim
    During each chemotherapy cycle eligible patients receive Peg-Filgrastim s.c. post chemotherapy application.
    Intervention: Drug: Peg-Filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
302
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Sandoz Biopharmaceuticals +49-8024-476-0
United States
 
NCT01516736
LA-EP06-302
Not Provided
Sandoz
Sandoz
Not Provided
Not Provided
Sandoz
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP