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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:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01516736
First received: January 13, 2012
Last updated: September 7, 2015
Last verified: September 2015
  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
Drug: Docetaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
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: March 2012
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 LA-EP2006 is injected s.c. post chemotherapy application.
Drug: Docetaxel Drug: Doxorubicin Drug: Cyclophosphamide
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.
Drug: Docetaxel Drug: Doxorubicin Drug: Cyclophosphamide

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Show 59 Study Locations
Sponsors and Collaborators
Sandoz
Investigators
Study Chair: Roumen Nakov, MD PhD Sandoz Biopharmaceuticals
  More Information

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: September 7, 2015
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
Cyclophosphamide
Doxorubicin
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on December 08, 2016