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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Neutropenic Complications, Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

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Trial Information

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


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.

Type of Study:

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

Outcome Measure:

Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy

Outcome Description:

Mean duration of severe neutropenia, defined as number of consecutive days with Grade 4 neutropenia.

Outcome Time Frame:

21 days (Cycle 1 of chemotherapy treatment)

Safety Issue:

Yes

Principal Investigator

Karsten Roth, Dr.

Investigator Role:

Study Chair

Investigator Affiliation:

Sandoz Biopharmaceuticals

Authority:

Russia: Ministry of Health of the Russian Federation

Study ID:

LA-EP06-301

NCT ID:

NCT01735175

Start Date:

June 2012

Completion Date:

December 2013

Related Keywords:

  • Neutropenic Complications
  • Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
  • Prevention of neutropenic complications in breast cancer patients
  • Pegfilgrastim,
  • G-CSF,
  • neutropenia,
  • breast cancer,
  • myelosuppressive chemotherapy,
  • supportive care
  • Breast Neoplasms

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