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Triple Negative Breast CancerPhase 3NCT06279364

A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

A Phase 3 study testing SKB264, Paclitaxel and Nab-paclitaxel in people with Triple Negative Breast Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site 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 aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior… 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, Paclitaxel and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
537 participants
Where
1 siteChina
Study dates
28 Feb 2024to Dec 2028
Phase
Phase 3

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

  • Histologically and/or cytologically confirmed TNBC.
  • De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent.
  • No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease.
  • Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease.
  • At least one measurable lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization.
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  • A life expectancy of at least 3 months.
  • Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator.
  • Adequate organ and bone marrow function.

Who cannot join

  • Active second malignancy.
  • Uncontrolled or clinical significant cardiovascular disease.
  • History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • Active infection requiring systemic therapy within 2 weeks of randomization.
  • Active hepatitis B or hepatitis C virus infection.
  • Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
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  • Known hypersensitivity to SKB264 or its excipients.
  • Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors.
  • Prior treatment with the same investigator's choice chemotherapy (except taxane).
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

Read the detailed description

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1/PD-L1 inhibitor in early setting.

Being tested
SKB264, Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin
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.

Study groups in NCT06279364
Study groupRoleWhat they receive
SKB264ExperimentalParticipants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle
Receives: Drug: SKB264
Investigator's choice chemotherapyActive comparatorIf no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel. If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin
Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Capecitabine; Drug: Eribulin; Drug: Carboplatin

What is being measured

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

  1. Overall Survival (OS)

    OS is defined as the time from randomization until the date of death due to any cause.

    Measured: Randomization up to approximately 40 months

  2. Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.

    Measured: Randomization up to approximately 28 months

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1

    Measured: Randomization up to approximately 28 months

  2. Duration of Response (DoR)

    DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.

    Measured: Randomization up to approximately 28 months

  3. Progression-Free Survival (PFS) assessed by Investigator

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.

    Measured: Randomization up to approximately 28 months

  4. Disease control rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/investigator per RECIST 1.1

    Measured: Randomization up to approximately 28 months

  5. Time to Response (TTR)

    TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.

    Measured: Randomization up to approximately 28 months

  6. Adverse events(AEs) and severe adverse events (SAEs)

    Incidence and severity of AEs and SAEs, and clinically significant lab abnormalities

    Measured: AEs should be collected from signing the informed consent form (ICF) until 30 days after the last dose

Timeline

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

  1. First posted28 Feb 2024
  2. Study start28 Feb 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionDec 2028 (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
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Masking
None (open label)
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279364
Sponsor's protocol ID
SKB264-Ⅲ-11
Status last verified
May 2026
First submitted
19 Feb 2024
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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