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Phase 3
18 Years
70 Years
Not Enrolling
Both
Breast Cancer, Neutropenia, Febrile Neutropenia

Thank you

Trial Information


Inclusion Criteria:



- Investigator diagnosis of breast cancer

- Age 18 to 70 years

- ECOG performance status ≤ 1

- Chemotherapy naïve

- Body weight ≥ 45kg

- Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 ×
109/L; platelet count ≥ 100 × 109/L

- Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine
≤1.5×ULN; total bilirubin ≤1.5×ULN

Exclusion Criteria:

- Prior bone marrow or stem cell transplantation

- Received systemic antibiotics treatment within 72 h of chemotherapy

- Radiation therapy within 4 weeks of randomization into this study

- Pregnancy, lactation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate and the duration of grade 3/4 neutropenia in cycle 1

Outcome Description:

Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.

Outcome Time Frame:

21 days

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

HHPG-19K -III-01

NCT ID:

NCT01611051

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Neutropenia
  • Febrile Neutropenia
  • breast cancer
  • neutropenia
  • febrile neutropenia
  • Breast Neoplasms
  • Fever
  • Neutropenia

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