Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC

NCT07007780 | Not Yet Recruiting Phase 2

• 1 other identifier: KY20252174-F-1
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.

Conditions

Triple -Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  At the end of Cycle 1 (each cycle is 14 days)

Secondary Outcomes (3)

• adverse effects

  through each neoadjuvant chemotherapy Cycle (each cycle is 14 days)]

• Objective Reaponse Rate(ORR)

  At the end of every cycle (each cycle is 14 days)

• Event-free survival (EFS)

  Up to 2 years

Study Arms (1)

Neadjuvant Sacituzumab Tirumotecan

EXPERIMENTAL

Neadjuvant Sacituzumab Tirumotecan

Drug: Sacituzumab Tirumotecan

Interventions

Sacituzumab Tirumotecan DRUG

Sacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks

Neadjuvant Sacituzumab Tirumotecan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Female subjects aged ≥18 years and ≤70 years at the time of signing the informed consent form.
• ECOG Performance Status: 0-1.
• Life Expectancy: Estimated survival of not less than 3 months.
• Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.
• Histopathological Diagnosis: Invasive breast cancer, staged as T1c N1-2 or T2-4 N0-2 according to the AJCC classification.
• TNBC Confirmation: Confirmed as TNBC based on histology and/or cytology, and meeting the following criteria:
• HER2-negative: IHC score of 0 or 1+; if IHC is 2+, confirmed negative by fluorescence in situ hybridization (FISH).
• ER and PR-negative: IHC showing \<1% of cells expressing hormone receptors; in case of multiple pathological results, the molecular subtype of the last biopsy is considered the final subtype.
• No Prior Systemic Anti-cancer Treatment: No prior systemic anti-cancer treatment.
• Availability of Tissue Samples: Availability of tissue samples for biomarker testing.
• Adequate Organ and Marrow Function: (No transfusions, recombinant human thrombopoietin, or colony-stimulating factor within 2 weeks before the first dose), defined as follows:
• Hematology: Absolute neutrophil count (NEUT#) ≥1.5×10\^9/L; platelets (PLT) ≥100×10\^9/L; hemoglobin ≥9 g/dL.
• Liver Function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); total bilirubin (TBIL) ≤1.5×ULN.
• Renal Function: Creatinine clearance (Ccr) ≥60 ml/min (Cockcroft-Gault formula is provided in the appendix).
• Coagulation Function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5×ULN.

You may not qualify if:

• Patients with metastatic breast cancer (Stage IV).
• Baseline left ventricular ejection fraction (LVEF) \<50% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at screening, or other significant cardiovascular diseases, or a history of Class III or IV cardiomyopathy described by the New York Heart Association on the same side as the invasive breast cancer.
• Chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer before enrollment.
• Previous treatment targeting TROP2 or treatment with a topoisomerase I inhibitor.
• A history of other malignancies within the past 5 years, excluding cured cervical in situ carcinoma, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
• Known allergy to the study drug or its components.
• A history of immunodeficiency or organ transplantation.
• Documented severe dry eye syndrome, severe meibomian gland disease, and/or blepharitis, or a history of corneal diseases that may impede delayed corneal healing.
• A history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspicious ILD or non-infectious pneumonia at screening that cannot be excluded by imaging studies; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months before dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or a history of pneumonectomy.
• Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as Type I diabetes, hypothyroidism requiring only thyroid hormone replacement, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement).
• Active infection requiring systemic treatment within 2 weeks before the first dose.
• Any comorbidities that, in the investigator's judgment, pose a serious risk to patient safety or may affect the patient's ability to complete the study, including but not limited to uncontrolled hypertension, severe diabetes, active infections, etc.
• Any condition or other circumstances that the investigator believes may interfere with the evaluation of the study drug, the safety of the subject, or the interpretation of the study results, or any other condition that the investigator deems unsuitable for participation in this study.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

NanLin Li

CONTACT

+86 13709113279; nanlin-74@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 6, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07