A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
NCT ID: NCT06279364
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
524 participants
INTERVENTIONAL
2024-02-28
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SKB264
Participants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle
SKB264
IV Infusion
Investigator's choice chemotherapy
If 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
Paclitaxel
IV Infusion.
Nab-paclitaxel
IV infusion.
Capecitabine
Tablet. Oral route of administration.
Eribulin
IV infusion.
Carboplatin
IV infusion.
Interventions
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SKB264
IV Infusion
Paclitaxel
IV Infusion.
Nab-paclitaxel
IV infusion.
Capecitabine
Tablet. Oral route of administration.
Eribulin
IV infusion.
Carboplatin
IV infusion.
Eligibility Criteria
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Inclusion Criteria
2. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent.
3. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease.
4. 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.
5. At least one measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization.
7. A life expectancy of at least 3 months.
8. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator.
9. Adequate organ and bone marrow function.
Exclusion Criteria
2. Uncontrolled or clinical significant cardiovascular disease.
3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
4. Active infection requiring systemic therapy within 2 weeks of randomization.
5. Active hepatitis B or hepatitis C virus infection.
6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
7. Known hypersensitivity to SKB264 or its excipients.
8. Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors.
9. Prior treatment with the same investigator's choice chemotherapy (except taxane).
10. Pregnant or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SKB264-Ⅲ-11
Identifier Type: -
Identifier Source: org_study_id
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