A Multicenter, Randomized, Double-blind Phase Ш Study to Evaluate the Efficacy and Safety in Patients With Advanced Breast Cancer Treated With SYHX2011 Compared to Paclitaxel for Injection (Albumin-bound)

CSPC Ouyi Pharmaceutical Co., Ltd.1 site in 1 country454 target enrollmentMay 1, 2023

ConditionsAdvanced Breast Cancer

InterventionsSYHX2011 Paclitaxel for injection (albumin-bound)

DrugsSYHX2011 Paclitaxel for injection (albumin-bound)

Overview

Phase: Phase 3
Intervention: SYHX2011
Conditions: Advanced Breast Cancer
Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Enrollment: 454
Locations: 1
Primary Endpoint: Objective Response Rate (ORR) by IRC
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety in patients with advanced breast cancer treated with SYHX2011 versus paclitaxel for injection (albumin-bound).

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

September 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the written informed consent.
•Breast cancer confirmed by histology or cytology and meeting the following conditions:
•According to the breast cancer diagnosis and treatment guidelines (2022) of the Chinese Society of Clinical Oncology (CSCO), the investigators judge the breast cancer patients who are suitable for anti-tumor treatment with paclitaxel for injection (albumin-bound) alone.
•According to RECIST 1.1 standard, there is at least one measurable focus. For the lesions that have been treated with radiotherapy in the past, the lesions can be included in the measurable lesions only if the disease progression is clear after radiotherapy.
•Age ≥ 18 years.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days before the first administration.
•Expected survival time ≥3 months.
•Normal function of main organs within 7 days before the first administration \[no blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or other medical support treatment within 14 days before the first administration\], meeting the following criteria:
•Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count (PLT)≥ 100 × 10\^9/L; Hemoglobin (Hb) ≥ 90 g/L.
•AST、ALT ≤ 10 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN and Creatinine clearance ≥ 30 mL/min.

Exclusion Criteria

•History of severe allergy or major hypersensitivity to paclitaxel or human serum albumin (NCI-CTCAE Version 5.0, ≥ Level 3).
•The toxicity of previous anti-tumor treatment has not recovered (NCI-CTC AE 5.0, \>Level 1); Skin reaction or other hypersensitivity caused by any reason does not return to normal.
•Patients with active brain metastasis without treatment (including symptomatic brain metastasis or meningeal metastasis); If the brain metastasis of the patient has been treated and the condition of the metastasis is stable (the brain imaging examination at least 4 weeks before the first administration shows that the lesion is stable, and there is no new nervous system symptom, or the nervous system symptom has returned to the baseline level, and there is no need for hormone treatment at least 14 days before the first administration of the investigational treatment), and there is no evidence of new or original brain metastasis enlargement, the patient is allowed to be enrolled.
•History of malignant tumors other than breast cancer within 5 years before the first administration, except for tumors that have recovered after treatment, such as carcinoma in situ, basal cell carcinoma, etc.
•There are any of the following concomitant diseases:
•Serious or uncontrolled cardiovascular diseases: such as chronic congestive heart failure of grade Ⅱ or above (NYHA standard), uncontrolled hypertension (excluding stable ones with systolic blood pressure\>150 mmHg and/or diastolic blood pressure\>90 mmHg after stable treatment), etc.
•There are clear neurological diseases (such as epilepsy, dementia, etc.) and ≥ grade 3 peripheral neuropathy.
•Serious respiratory diseases, such as asthma requiring glucocorticoid drugs, chronic obstructive pulmonary disease (acute exacerbation), etc.
•Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L after stable treatment).
•Serious chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment (such as anti-infective drugs have been used for more than one week before the first administration and will continue to be used), including tuberculosis infection, etc.