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Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints

NCT ID: NCT06616571

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2025-12-30

Brief Summary

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The goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.

Detailed Description

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Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.

Conditions

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Chemotherapy-Induced Febrile Neutropenia

Keywords

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Febrile Neutropenia, Breast Cancer, Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24h group

Group Type EXPERIMENTAL

QL0605(PEG-rhG-CSF)

Intervention Type DRUG

Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 24 hours s.c. post chemotherapy application.

QL0605(PEG-rhG-CSF)

Intervention Type DRUG

Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 48 hours s.c. post chemotherapy application.

48h group

Group Type ACTIVE_COMPARATOR

QL0605(PEG-rhG-CSF)

Intervention Type DRUG

Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 24 hours s.c. post chemotherapy application.

QL0605(PEG-rhG-CSF)

Intervention Type DRUG

Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 48 hours s.c. post chemotherapy application.

Interventions

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QL0605(PEG-rhG-CSF)

Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 24 hours s.c. post chemotherapy application.

Intervention Type DRUG

QL0605(PEG-rhG-CSF)

Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks. During each chemotherapy cycle QL0605 is injected 48 hours s.c. post chemotherapy application.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged≥18 years；
* The expected survival period is more than 3 months;
* ECOG≤ 2;
* Invasive breast cancer diagnosed by histopathology;
* Plan to receive TAC, TC or TCbH chemotherapy;
* Subjects with good hematology, liver, lung and kidney function ;
* Signed informed consent.

Exclusion Criteria

* Known hypersensitivity to rhG-CSF or PEG-rhG-CSF;
* Female patients during pregnancy or lactation;
* The previous malignant tumors were not cured;
* Received chemotherapy or radiotherapy within 4 weeks before screening;
* Received PEG-rhG-CSF within 6 weeks before screening;
* Suffering from uncontrollable infectious diseases within 2 weeks before screening.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shandong Cancer Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mengli Zhu, Master

Role: CONTACT

Phone: 13256715221

Email: [email protected]

Wangwang Zhi, Master

Role: CONTACT

Phone: 17761716313

Email: [email protected]

Facility Contacts

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Wangwang Zhi

Role: primary

Other Identifiers

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QL0605-401

Identifier Type: -

Identifier Source: org_study_id