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Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

NCT05283616 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2024-03-19

No results posted yet for this study

Summary

Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently.

According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg.

In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.

Conditions

Interventions

DRUG

Pegfilgrastim

Pegfilgrastim 3mg per chemotherapy cycle

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Pin Zhang · Department of Medical Oncology, Cancer Hospital, CAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2019-10-10
Completion
2021-10-15

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283616 on ClinicalTrials.gov