Intra-patient trial of peg-filgrastim to Reduce the non-hematological toxicity and improve patient reported outcome in the patients with Breast cancer
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 62
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of febrile neutropenia;Other hematologic toxicity: collected based on CTCAE ver 5.0