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Compares treatment options for Triple Negative Breast Cancer
Official title A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT06279364
What this study is testing
What is SKB264?
SKB264 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- At least one measurable lesion per RECIST v1.1.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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. Key
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.