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Triple Negative Breast CancerPhase 3NCT05347134

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

A Phase 3 study testing SKB264 in people with Triple Negative Breast Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
SKB264
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
2 sitesChina
Study dates
10 Jun 2022to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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;
  • Subjects must have adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony stimulating factor therapy has been received within 2 weeks prior to the screening), which is defined as follows:
  • Hematology: neutrophil count (NEUT) ≥ 1.5 × 109 /L; platelets (PLT) ≥ 100 × 109 /L; hemoglobin ≥ 9 g/dL;
  • Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 × ULN; for patients with liver metastases, ALT and AST must be ≤ 5 × ULN, TBIL ≤ 2 × ULN; for patients with liver or bone metastases, ALP must be ≤ 5 × ULN;
  • Albumin ≥ 3 g/dL;
  • Renal function: creatinine clearance (Ccr) ≥ 60 ml/min (see Annex for Cockcroft-Gault formula);
  • Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5 × ULN;
  • Subjects must have recovered from all toxicities (except alopecia) due to prior treatments to ≤ grade 1 based on the assessment per CTCAE 5.0 criteria;
  • Subjects voluntarily participate in the study, sign the informed consent form, and will be able to comply with the protocol-specified visits and relevant procedures.

Who cannot join

  • 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;
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  • 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;
  • Patients with current or previous active chronic inflammatory bowel disease or intestinal obstruction or gastrointestinal (GI) perforation;
  • Uncontrolled hypertension (systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg), with a history of unstable hypertension, or with a history of poor compliance with antihypertensive treatment;
  • Uncontrolled diabetes (fasting glucose ≥ 10 mmol/L and/or glycated hemoglobin (HbA1c) ≥ 8%);
  • Active hepatitis B (hepatitis B surface antigen positive, and HBV-DNA above 500 IU/ml or 1x ULN, whichever is higher) or hepatitis C (hepatitis C antibody positive, and HCV-RNA above 1x ULN); with known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); positive syphilis antibody test;
  • History of serious drug allergy, with known allergy to macromolecular protein preparations or any component of the study drug formulation;
  • Pregnant or lactating women; or patients of childbearing potential (male or female) who cannot use effective medical contraception during the study treatment period and for 6 months after the end of the dosing period (see Annex for specific contraceptive measures);
  • During the screening process prior to the first dose, the condition deteriorated rapidly, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy;
  • Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
SKB264
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKB264Drug

    Also called Eribulin, Capecitabine, Gemcitabine, Vinorelbine

    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.

Study groups in NCT05347134
Study groupRoleWhat they receive
SKB264Active comparator5 mg/kg, IV (in the vein) on day 1 and Day 15 of each 28 day cycle.
Receives: Drug: SKB264
Eribulin or Capecitabine or Gemcitabine or VinorelbineActive comparatorEribulin: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.
Receives: Drug: SKB264

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

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

    Measured: up to 24 months

Secondary outcomes (5)

  1. Progression-free survival(PFS)

    Progression-free survival (PFS) assessed by the investigators according to RECIST V 1.1

    Measured: up to 24 months

  2. Objective Response Rate (ORR)

    The percentage of patients with CR and PR assessed by the Independent Review Committee and investigators according to RECIST v 1.1

    Measured: up to 24 months

  3. Disease Control Rate (DCR)

    The proportion of patients who have achieved CR，PR and SD assessed by the Independent Review Committee and investigators according to RECIST v 1.1

    Measured: up to 24 months

  4. Duration of Response (DoR)

    From the date that response criteria are first met to the first occurrence of PD as determined by the Independent Review Committee and investigators according to RECIST v1.1 or death from any cause, whichever occurs first

    Measured: up to 24 months

  5. Overall Survival (OS)

    OS, defined as the time from randomization to death or lose of follow, whichever occurs first

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start10 Jun 2022
  3. Primary completion30 Nov 2023
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05347134
Sponsor's protocol ID
SKB264-Ⅲ-03
Status last verified
May 2026
First submitted
15 Apr 2022
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fan Y, Ouyang Q, Yin Y, 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 detailed safety analysis of the randomized OptiTROP-Breast01 study. Breast Cancer Res. 2026 Sep 28;28(1):163. doi: 10.1186/s13058-026-02339-z.

    PubMed 42806387

  • 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.

    PubMed 40217078

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SKB264 in people with Triple Negative Breast Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05347134, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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