Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/?HER2-) Breast Cancer
Conditions
Interventions
Experimental arm:Sacituzumab Tirumotecan + Tagitanlimab
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-70 years, and previously untreated female patients with breast cancer; 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 4. Have at least 1 measurable disease defined by RECIST v1.1; 5. Pathologically confirmed invasive ductal breast cancer, T1c-T2 (tumor size >=2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2; 6.Has confirmed ER+/HER2-:ER>=1%HER2 IHC 01+ or 2+/ISH-); 7.Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%; 8.Tissue or blood available for biomarker assessment; 9.Adequate organ function; 10.Patients with negative serum pregnancy test and those with fertility potential must agree to use effective contraception during the treatment period and for at least 3 months after the last dose of study drugs; 11.Patients must voluntarily participate in this study, sign an informed consent form, exhibit good compliance, and be willing to cooperate with follow-up procedures;
Exclusion criteria
Exclusion criteria: 1.Inflammatory BC; 2.Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast); 3.Has bilateral invasive breast cancer; 4.Has metastatic (stage IV) breast cancer; 5.Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening; 6.Has received prior treatment for breast cancer; 7.Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137); 8.Has received prior treatment for targeting TROP2 and/or topoisomerase I; 9.Patients who have had other malignancies within the past five years will be excluded from the study, with exceptions for those who have been successfully treated for cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma of the skin; 10.Has hypersensitivity to any of the components or excipients used in the study treatments; 11.History of allogeneic organ transplantation; 12.Patients with a history of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, those currently diagnosed with ILD or non-infectious pneumonia, or those with suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging at the time of screening, will be excluded. Additionally, patients suffering from clinically severe pulmonary damage due to pulmonary comorbidities will also be excluded. This includes, but is not limited to, any underlying pulmonary disease (such as pulmonary embolism within the past three months, severe asthma, advanced chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory conditions potentially affecting the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), as well as those who have undergone a pneumonectomy; 13.Patients with active autoimmune diseases requiring systemic treatment within the past two years will be excluded from the study. Systemic treatment does not include hormone replacement therapy, such as insulin therapy for Type 1 Diabetes, thyroid hormone replacement for hypothyroidism, or physiological doses of glucocorticoids for adrenal or pituitary insufficiency. 14.Patients with active infection requiring systemic therapy; 15.According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to high blood pressure beyond the control of drugs, serious diabetes, active infection, etc; 16.History of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal disease that interferes with delayed corneal healing; 17.Patients for whom participation in the study was deemed to be inappropriate by the investigator for any other reason were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Safety;Breast Pathological Complete Response (pCR) Rate (ypT0/Tis);Objective response rate (ORR);Event-Free Survival (EFS); | — |
Countries
China
Contacts
Public ContactTing Luo
West China Hospital of Sichuan University
Outcome results
None listed