A study evaluating the safety of dose-dense EC with pegfilgrastim.

A study evaluating the safety of dose-dense EC with pegfilgrastim. - A study evaluating the safety of dose-dense EC with pegfilgrastim.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020834

Enrollment

Registered

2016-02-02

Start date

2015-12-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

ddEC therapy

epirubicine 90mg/m2 Day1 cyclophosphamide 600mg/m2 Day1 PEG-filgrastim 3.6mg Day4 q14, 4 cycle evaluate at 3 months afer the last registration.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1 Patients requiring ddEC therapy 2 informed consent 3 EF>50 4 20<=age<70 5 ECOG PS: 0-1

Exclusion criteria

Exclusion criteria: 1 allergic for G-CSF 2 a case of active infection 3 pregnancy or breast-feeding 4 severe comobidity

Design outcomes

Primary

Measure	Time frame
rate of severe adverse event	—

Secondary

Measure	Time frame
rate of febrile neutropenia, oher adverse event	—

Countries

Japan

Contacts

Public ContactShinichiro Kubo

Fukuyama city hospital Department of Breast and thyroid surgery

shikubo@city.fukuyama.hiroshima.jp084-941-5151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026