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Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta® (PROTECT 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01735175
First received: November 22, 2012
Last updated: September 20, 2013
Last verified: July 2012
  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
Neutropenic Complications
Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
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: A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

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: 10 months ] [ Designated as safety issue: Yes ]

Enrollment: 318
Study Start Date: June 2012
Study Completion Date: September 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  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: NCT01735175

Locations
Russian Federation
Regional Budgetary Healthcare Institution "Kursk Regional Clinical Oncological Dispensary" of Committee Healthcare of Kursk Territory, Russia
Kursk, Russian Federation
Sponsors and Collaborators
Sandoz
Investigators
Study Chair: Karsten Roth, Dr. Sandoz Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01735175     History of Changes
Other Study ID Numbers: LA-EP06-301, 2011-004532-58
Study First Received: November 22, 2012
Last Updated: September 20, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Sandoz:
Prevention of neutropenic complications in breast cancer patients
Pegfilgrastim,
G-CSF,
neutropenia,
breast cancer,
myelosuppressive chemotherapy,
supportive care

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014