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Phase 2, Open-Label, Dose-Ranging Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophophamide (TC) Regimen


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Neutropenia

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Trial Information

Phase 2, Open-Label, Dose-Ranging Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophophamide (TC) Regimen


This is an open label, multicenter, dose ranging study, sequentially enrolled by study dose,
with a non-inferiority design to compare the effectiveness of HM10460A relative to a fixed
dose of pegfilgrastim as a concurrent active control to each dose of HM10460A in patients
with breast cancer. The study will include 4 arms: 3 dose levels of HM10460A versus
pegfilgrastim. The start of study treatment is defined as the initiation of HM10460A or
pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles, which begin on
Day 1 with chemotherapy administration and continue through Day 21.

The planned number of patients is a total of 144 based on 36 enrolled into each of 4
treatment arms. The target population are patients with breast cancer who are candidates for
neoadjuvant or adjuvant treatment with TC chemotherapy. All patients who receive at least 1
dose of either HM10460A or pegfilgrastim will be followed for safety through 20 (± 2) days
after their last dose of study treatment or until all treatment-related AEs have resolved or
returned to baseline/Grade 1, whichever is longer, or until it is determined that the
outcome will not change with further follow-up.


Inclusion Criteria:



- Histologically confirmed breast cancer who is a candidate for adjuvant or neoadjuvant
chemotherapy

- Candidate for docetaxel and cyclophosphamide chemotherapy

- Female ≥ 18 years of age

- ECOG ≤ 2

- ANC ≥ 1.5 x 109/L

- Platelet count ≥ 100 x 109/L

- Creatinine ≤ 1.5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL (≤ 25.65 μmol/L)

- AST/SGOT and/or ALT/SGPT ≤ 1.5 x ULN

- Hemoglobin > 9 g/dL

- Alkaline phosphatase ≤ 1.5 x ULN

Exclusion Criteria:

- Known sensitivity to E. coli derived products or known sensitivity to any of the
products to be administered during dosing

- Known HIV infection

- HBV or HCV diagnosis with detectable viral load or immunological evidence of chronic
active disease

- Active infection or any serious underlying medical condition, which would impair the
ability of the patient to receive protocol treatment

- Prior bone marrow or stem cell transplant

- Prolonged exposure to glucocorticosteroids and immunosuppressive agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Duration of severe neutropenia (DSN) in Cycle 1

Outcome Description:

DSN in Cycle 1, with severe neutropenia defined as ANC < 500 cells/μL (Grade 4 neutropenia, per NCI CTCAE). DSN is defined as the interval from the day of first observation of Grade 4 neutropenia to first ANC recovery to ≥ 2,000 cells/μL (Grade 0). Patients who do not present with Grade 4 neutropenia are censored in this analysis.

Outcome Time Frame:

Up to 21 days

Safety Issue:

Yes

Principal Investigator

Thomas Niederman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

SPI-GCF-12-201

NCT ID:

NCT01724866

Start Date:

January 2013

Completion Date:

December 2014

Related Keywords:

  • Neutropenia
  • Breast Neoplasms
  • Neutropenia

Name

Location
North County Oncology Oceanside, California  92056
Beaver Medical Group Highland, California  92346
Arizona Center for Cancer Care Glendale, Arizona  85306
California Cancer Associates for Research and Excellence Fresno, California  93720
Desert Springs Cancer Care Scottdale, Arizona  85255
Hematology Oncology Medical Group Orange, California  92868
Thomas Niederman, M.D., Ph.D Boynton Beach, Florida  33426
Good Samaritan Hospital, Corvallis Corvallis, Oregon  97330