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Trial Title:
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
NCT ID:
NCT06279364
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SKB264
Description:
IV Infusion
Arm group label:
SKB264
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
IV Infusion.
Arm group label:
Investigator's choice chemotherapy
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
IV infusion.
Arm group label:
Investigator's choice chemotherapy
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Tablet. Oral route of administration.
Arm group label:
Investigator's choice chemotherapy
Intervention type:
Drug
Intervention name:
Eribulin
Description:
IV infusion.
Arm group label:
Investigator's choice chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV infusion.
Arm group label:
Investigator's choice chemotherapy
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 anti-programmed cell death 1
(PD-1)/PD-L1 inhibitor in early setting
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Histologically and/or cytologically confirmed TNBC.
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.
Key Exclusion Criteria:
1. Active second malignancy.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhimin Shao
Email:
szm@163.com
Start date:
February 28, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279364
