TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- pathological complete response (pCR) rate
Study Overview
Brief Summary
Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG/I (sacituzumab govitecan/PD-1 inhibitor) shows clinical promise, validation of responder identification tools is warranted. This phase II trial aims to identify a precision TNBC population suitable for de-escalated neoadjuvant therapy with sacituzumab govitecan plus tislelizumab, based on differential Trop-2 expression (±) and PD-L1 status (CPS >10% vs. <10%). Primary endpoints include pCR rate and safety; exploratory biomarker analyses will assess mechanisms of response/resistance
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Age ≥ 18 years;
- •Histologically confirmed stage II or III primary invasive TNBC TNBC defined as: immunohistochemistry (IHC) ER and PR <1%; HER2-negative, IHC 0 or 1+, IHC 2+, ISH-;
- •ECOG performance status score 0-1;
- •Provision of an acceptable tumor sample prior to randomization;
- •Bone marrow hematopoietic and organ function must meet study requirements; Without growth factor support or blood transfusion, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; Creatinine ≤ 1.5 × ULN; Urinalysis showing proteinuria < 2+ or 24-hour urine protein < 1 g; Coagulation function must be normal, defined as: International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN and/or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. If anticoagulant therapy is ongoing, PT must remain within the therapeutic range for the anticoagulant used.
- •Serum amylase ≤ 1.5×ULN and serum lipase ≤ 1.5×ULN.
Exclusion Criteria
- •1. Evidence of severe/uncontrolled systemic disease, including active infections requiring intravenous therapy, severe chronic gastrointestinal disease associated with diarrhea, active bleeding disorders, severe cardiac or psychiatric disorders, or history of allogeneic organ transplantation;
- •History of other primary malignancies with known active disease within 3 years prior to randomization and low potential for recurrence (excluding adequately excised non-melanoma skin cancers and treated carcinoma in situ);
- •Active or documented history of autoimmune or inflammatory diseases;
- •Presence of distant metastases;
- •Active or uncontrolled hepatitis B or C infection, uncontrolled HIV infection, or active tuberculosis;
- •History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, any clinically active interstitial lung disease, or immune-related pneumonitis induced by immunotherapy;
- •Any prior or concurrent surgery, radiotherapy, or systemic anticancer therapy for TNBC;
- •Prior exposure to the following treatments: Immunosuppressive drug therapy within 14 days before the first study intervention Live attenuated vaccines within 30 days before the first study intervention
Arms & Interventions
SG+I
SG 10mg/kg， d1,d8 q3w
+ I 200mg, d1 q3w 6 cycles （18 weeks）
Intervention: SG+I (Drug)
Outcomes
Primary Outcomes
pathological complete response (pCR) rate
Time Frame: From enrollment to the end of treatment at 24 weeks
To evaluate the pathological complete response (pCR) rate (ypT0/Tis ypN0) following neoadjuvant sacituzumab govitecan plus immunotherapy (SG/I) in biomarker-selected TNBC
Secondary Outcomes
No secondary outcomes reported
Investigators
Yingying Xu
Professor
First Hospital of China Medical University