Intra-patient trial of peg-filgrastim to Reduce the non-hematological toxicity and improve patient reported outcome in the patients with Breast cancer

Phase 2, open label, intra-patient trial of peg-filgrastim to Reduce the non-hematological toxicity and improve patient reported outcome in the patients with Breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004194

Enrollment

Registered

2019-08-13

Start date

2019-06-03

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

None listed

Interventions

Drug : Subjects who meet the criteria for selection / exclusion criteria are assigned as group A and group B. The study alternatively assign the patients as group A and B in the order of enrollment in

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed breast cancer patients 2. female 3. Under 65 age 4. Patients who have received or are scheduled to receive surgical treatment for a cure 5. Patients receiving anthracycline-based chemotherapy for preoperative or postoperative adjuvant chemotherapy. 6. Physical functions appropriate for treatment a. Absolute neutrophil count (ANC) =1500 cells / mm3 b. Platelets =100,000 cells / mm3 c. Estimated creatinine clearance =50 mL / min, or serum creatinine <1.5 x upper limit of normal (ULN) d. Bilirubin =1.5 x ULN e. AST (SGOT)? 2.5 x ULN f. ALT (SGPT)? 2.5 x ULN g. 12-lead electrocardiogram (ECG) findings that are clinically insignificant changes that do not require normal or medical intervention.

Exclusion criteria

Exclusion criteria: 1. Male patient 2. Anthracycline-based chemotherapy is not appropriate for patients 3. Patients with severe medical conditions that are not suitable for clinical trial enrollment 4. Patients who are pregnant or lactating, or who do not agree to perform appropriate contraception during the trial 5. Patients who are unwilling or unable to agree to participate in clinical trials

Design outcomes

Primary

Measure	Time frame
Patient Reported Outcome of Quality Of Life (QOL) measured by EORTC QLQ-C30 & EORTC-OH15 questionnaire (baseline, after cycle 1, and after cycle2);non-hematologic toxicity (CTCAE ver.5.0)	—

Secondary

Measure	Time frame
Incidence of febrile neutropenia;Other hematologic toxicity: collected based on CTCAE ver 5.0	—

Countries

Korea, Republic of

Contacts

Public ContactJoohyuk Sohn

Yonsei University Health System, Severance Hospital

oncosohn@yuhs.ac+82-2-2228-8135

Outcome results