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

NCT05347134 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: SKB264-Ⅲ-03
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) as assessed by an Independent Review Committee (IRC) based on RECIST 1.1

  up to 24 months

Secondary Outcomes (5)

• Progression-free survival(PFS)

  up to 24 months

• Objective Response Rate (ORR)

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Duration of Response (DoR)

  up to 24 months

• Overall Survival (OS)

  up to 24 months

Study Arms (2)

SKB264

ACTIVE COMPARATOR

5 mg/kg, IV (in the vein) on day 1 and Day 15 of each 28 day cycle.

Drug: SKB264

Eribulin or Capecitabine or Gemcitabine or Vinorelbine

ACTIVE COMPARATOR

Eribulin:1.4mg/m2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle. Capecitabine:1000-1250mg/m2, po,bid, from day 1 to Day 15 of each 21 day cycle. Gemcitabine:800-1000 mg/m2, IV (in the vein) on day 1 and Day 8 of each 21day cycle. Vinorelbine:25 mg/m2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle.

Drug: SKB264

Interventions

SKB264 DRUG

SKB264 ：5 mg/kg, IV (in the vein) on day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Eribulin:1.4mg/m2, IV (in the vein) on day 1 and Day 8 of each 281day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Capecitabine:1000-1250mg/m2, po,bid, from day 1 to Day 15 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Gemcitabine:800-1000 mg/m2, IV (in the vein) on day 1 and Day 8 of each 281day cycle. Number of Cycles: until progression or unacceptable toxicity develops. Vinorelbine:25 mg/m2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Also known as: Eribulin, Capecitabine, Gemcitabine, Vinorelbine

Eribulin or Capecitabine or Gemcitabine or Vinorelbine; SKB264

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will not be included unless they meet all of the following criteria:
• Males or females age 18 to 75 years old (inclusive) at the time of signing the informed consent form;
• 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:
• 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).
• Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC;
• Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two lines of standard of care regimens, including:
• Any treatment received by the patients regardless of triple-negative state can be included as one of the standard of care regimens;
• 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;
• 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;
• 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;
• Patients must have progressed on or were intolerable to the treatment during or after the last treatment prior to enrollment;
• All patients must have been previously treated with taxanes; and those who have been treated with taxanes for at least 1 cycle and show contraindications or intolerability during or at the end of the cycle can be included, regardless of the disease stage during this treatment;
• Patients must have at least one measurable lesion per RECIST v1.1 criteria; those with only skin or bone lesions cannot be included;
• Subjects with a Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with an expected survival of ≥ 12 weeks;
• Subjects must provide tumor tissues or tissue specimens;

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded:
• Patients with a history of central nervous system (CNS) metastases or current CNS metastases;
• 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;
• Patients with Gilbert's disease;
• Patients who have received prior TROP2-targeted therapy;
• Patients who have received live vaccines within 30 days prior to the first dose;
• 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);
• 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;
• With concomitant infections requiring systemic antibiotic therapy within 1 week prior to the first dose of study treatment;
• Presence of any serious and/or uncontrolled comorbidities that prevent the patient from participating in the study, such as:
• Impaired cardiac function, including any of the following: (not necessarily all of the following):
• aa) Corrected QT interval (QTcF) between ventricular depolarization to repolarization \> 480 ms at baseline; ab) Left ventricular ejection fraction (LVEF) \< 50% as indicated by echocardiography (ECHO) ;
• Other clinically significant heart diseases, including any of the following known medical history:
• ba) Angina pectoris; bb) Congestive cardiac failure; bc) Myocardial infarction;
• Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease;

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

• Yin Y, Fan Y, Ouyang Q, Song L, Wang X, Li W, Li M, Yan X, Wang S, Sun T, Teng Y, Tang X, Tong Z, Sun Z, Ge J, Jin X, Diao Y, Liu G, Xu B. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2025 Jun;31(6):1969-1975. doi: 10.1038/s41591-025-03630-w. Epub 2025 Apr 11.

  PMID: 40217078 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

eribulin; Capecitabine; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomly divided into the experiment group and control group in a 1:1 ratio, stratified by: number of previous treatment lines (2-3 vs. \>3); Presence of liver metastases (yes vs. No)

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 26, 2022
• Study Start: June 10, 2022
• Primary Completion: November 30, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

CN (2)