A Single-arm Open-label Phase II Study to Evaluate the Efficacy and Safety in Subjects With Advanced Breast Cancer Treated With SYHX2011

CSPC Ouyi Pharmaceutical Co., Ltd.1 site in 1 country80 target enrollmentApril 2024

ConditionsAdvanced Breast Cancer

InterventionsSYHX2011

DrugsSYHX2011

Overview

Phase: Phase 2
Intervention: SYHX2011
Conditions: Advanced Breast Cancer
Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Enrollment: 80
Locations: 1
Primary Endpoint: Objective Response Rate (ORR) by Investigator
Status: Not yet recruiting
Last Updated: 2 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 subjects with advanced breast cancer treated with SYHX2011

Registry

clinicaltrials.gov

Start Date

April 2024

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Voluntarily sign the written informed consent and willing to cooperate with the research according to the requirements of the plan.
•2.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 breast cancer patients who are suitable for anti-tumor treatment with paclitaxel for injection (albumin-bound) alone judged by the investigators.
•According to RECIST 1.1 standard, there is at least one measurable lesion. For the lesions that have been treated with radiotherapy in the past, only if the disease progression is clear after radiotherapy, then the lesions can be included as the measurable lesions.
•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 symptomatic brain metastasis or meningeal metastasis, or there is any evidence that shows uncontrolled brain metastasis or meningeal metastasis.
•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 (systolic blood pressure\>150 mmHg and/or diastolic blood pressure\>90 mmHg after regular treatment), etc.
•There are clearly identified 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 regular 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.