Actively Recruiting
Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-01-27
40
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.
CONDITIONS
Official Title
Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Diagnosed with primary triple-negative breast cancer (tumor size 2 cm, clinical lymph node stage cN0 to cN3, no distant metastasis)
- Tumor tissue sample available for biomarker testing
- At least one measurable lesion by RECIST v1.1 (excluding previously irradiated lesions, only skin or bone lesions excluded)
- ECOG Performance Status score of 0 or 1 within 7 days before treatment
- Adequate organ and bone marrow function as defined by blood counts, liver, kidney, coagulation, and heart function criteria
- No prior anti-tumor therapy for current breast cancer
- Negative pregnancy test for females; agreement to use effective contraception during and 6 months after study
- Able to provide written informed consent and comply with study procedures
You will not qualify if you...
- Left ventricular ejection fraction (LVEF) below 55% or significant cardiovascular disease (NYHA Class III or IV)
- History of ipsilateral invasive breast cancer
- Any prior chemotherapy, targeted therapy, or radiotherapy for current breast cancer
- Previous treatment with immune checkpoint inhibitors or TROP2/topoisomerase I inhibitor therapies
- Other active malignancies within 5 years except certain cured skin or cervical cancers
- Significant pulmonary impairment or diseases including recent pulmonary embolism, severe asthma, COPD, or autoimmune diseases affecting lungs
- History of pneumonectomy
- Use of strong CYP3A4 inhibitors or inducers within 2 weeks before or during study
- Allergy or hypersensitivity to study drugs or components; history of immunodeficiency or organ transplant
- History or current interstitial lung disease or non-infectious pneumonitis needing steroids
- Severe eye diseases affecting corneal healing
- Active autoimmune disease requiring systemic treatment within past 2 years (with some exceptions)
- Active infection needing systemic treatment within 2 weeks before first dose
- Uncontrolled illnesses that may affect safety or study completion
- Any other condition judged by investigator to interfere with study or patient safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
X
Xiaosong Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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