Clinical trial NCT03575520: Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients
Official title: A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
dose-dense chemotherapy
pegfilgrastim
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 63
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.

Detailed description: Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.

The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).

Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).

A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).

Clinical, hematological, and biochemical assessments were done before the start of each cycle.

Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).

Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of a primary breast cancer (stage I-III)
* Age \> 18 years of age and Age \< 66 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1
* Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy
* Adequate organ functions

  1. ANC ≥1500 cells/mm3
  2. PLT ≥100,000 cells/mm3
  3. CCr ≥50 mL/min, or Serum Cr \<1.5 x (upper limit of normal, ULN)
  4. Total bilirubin ≤1.5 x ULN
  5. AST (SGOT) ≤2.5 x ULN
  6. ALT (SGPT) ≤2.5 x ULN

Exclusion Criteria:

* Previous chemotherapy history
* Previous bone marrow transplantation history
* Sickle cell anemia
* Radiation therapy within 4 weeks from enrollment
* Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment
* Clinically significant systemic illness (serious infection, liver, kidney, heart disease)
* Pregnant, breast feeding women

Primary outcomes:
measure: the incidence of febrile neutropenia (FN)
timeFrame: 2months
Secondary outcomes:
measure: the incidences of febrile neutropenia during the first cycle of chemotherapy
timeFrame: At the end of Cycle 1 (each cycle is 14days)
measure: the incidences of hospitalization for FN
timeFrame: 2months
measure: number of grade 3 or 4 neutropenia in the first cycle of DD-AC
timeFrame: 2months
measure: the incidences of dose delay or reduction of chemotherapy
timeFrame: 2months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Study officials:
References: