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SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed Second-line or Above Prior Standard of Care

NCT05347134•Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed second-line or above prior standard of care

Detailed Description

The 2021 CSCO guidelines recommend treatment for patients with advanced TNBC as follows: Taxoides are generally preferred for patients who have failed anthracycline therapy in the past; For patients with anthracycline and taxane treatment failure, there is no standard therapy. Previously unused chemotherapy alone or in combination can be considered. However, the toxicity of combination chemotherapy is high and the survival benefit is limited, therefore, in consideration of the quality of life of advanced patients, single-agent chemotherapy is recommended as a priority.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects will not be included unless they meet all of the following criteria:
•1. Males or females age 18 to 75 years old (inclusive) at the time of signing the informed consent form;
•2. Histologically and/or cytologically confirmed TNBC based on pathology reports on recent biopsy specimens or other pathological samples (central laboratory confirmation is not required), including:
•1. Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH).
•2. Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC;
•3. Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two lines of standard of care regimens, including:
•1. Any treatment received by the patients regardless of triple-negative state can be included as one of the standard of care regimens;
•2. For patients whose treatment regimens have been changed due to intolerability to toxicity, the intolerable regimens can be included as one of the prior standard of care regimens;
•3. For neoadjuvant and/or adjuvant chemotherapy, if relapse or disease progression to unresectable locally advanced or metastatic disease occurs during treatment or within 12 months after discontinuation of treatment (at least 2 cycles have been completed), it will be considered as one of the standard of care regimens. And the patients must also have received one therapy and have progressed on this therapy during the stage of unresectable locally advanced or metastatic disease;
•4. For patients with documented germline BRCA1/BRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can be considered as one of the 2 prior standard of care regimens required;
+13 more criteria

Exclusion Criteria

•Subjects who meet any of the following criteria will be excluded:
•1. Patients with a history of central nervous system (CNS) metastases or current CNS metastases;
•2. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;
•3. Patients with Gilbert's disease;
•4. Patients who have received prior TROP2-targeted therapy;
•5. Patients who have received live vaccines within 30 days prior to the first dose;
•6. Patients who required the treatment of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment (strong inhibitors or inducers of CYP3A4 are not allowed in this study, and representative drugs of strong CYP3A4 inhibitors or inducers are listed in the Annex). Patients who received continued high dose of systemic corticosteroids within 2 weeks prior to the first dose (low-dose corticosteroids, such as ≤ 10 mg daily prednisone or equivalent, are allowed if the dose is stable for 4 weeks);
•7. Patients who have received any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, biological therapy or other drugs within 4 weeks prior to the first dose of study treatment or within 5 half-lives of the drug used in the previous period (whichever is shorter), or received treatment with traditional Chinese medicine preparations for approved anti-tumor indications 2 weeks prior to the first dose of study treatment, or received major surgeries 4 weeks prior to the first dose of study treatment;
•8. With concomitant infections requiring systemic antibiotic therapy within 1 week prior to the first dose of study treatment;
•9. Presence of any serious and/or uncontrolled comorbidities that prevent the patient from participating in the study, such as:
+13 more criteria

Locations (2)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

June 10, 2022

Primary Completion Date

November 30, 2023

Completion Date

June 30, 2027

Last Updated

December 9, 2025

Enrollment

254

ESTIMATED participants

Conditions

Triple Negative Breast Cancer

Interventions

SKB264

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

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