Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

NCT03575520 | Completed Phase 2

• 1 other identifier: 4-2015-0813
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; dose-dense chemotherapy; pegfilgrastim

Outcome Measures

Primary Outcomes (1)

• the incidence of febrile neutropenia (FN)

  FN is defined as neutropenia (\<500 neutrophils/μL) with a febrile event (a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period).

  2months

Secondary Outcomes (4)

• the incidences of febrile neutropenia during the first cycle of chemotherapy

  At the end of Cycle 1 (each cycle is 14days)

• the incidences of hospitalization for FN

  2months

• number of grade 3 or 4 neutropenia in the first cycle of DD-AC

  2months

• the incidences of dose delay or reduction of chemotherapy

  2months

Study Arms (1)

Peg group

EXPERIMENTAL

Drug: Pegfilgrastim; Drug: Doxorubicin/Cyclophosphamide(AC) treatment

Interventions

Pegfilgrastim DRUG

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).

Peg group

Doxorubicin/Cyclophosphamide(AC) treatment DRUG

doxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks Four cycles of dose dense AC treatment will be given every 2 weeks.

Peg group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Gender Eligibility Details: female population
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastim; Doxorubicin; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 2, 2018
• Study Start: June 7, 2016
• Primary Completion: February 15, 2017
• Study Completion: March 15, 2017
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)