A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Recruiting · NCT05911958 · Interventional (participants receive a specific treatment) · Lead sponsor: Henan Cancer Hospital
View the official record on ClinicalTrials.gov →Interventions studied
SHR-A1811 for injection
What this trial is about
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients aged 18 to 70 years old (inclusive);
- Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
- HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
- ECOG performance status of 0-1;
- Normal organ and bone marrow function;
- Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;
- Patients voluntarily joined the study and signed informed consent;
Exclusion criteria
- Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
- Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;
- Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;
- Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;
- Clinically significant pulmonary or cardiovascular disease;
- Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;
- Known to be allergic to any study drug or any of its excipients;
- History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Pregnant and lactating women;
- Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.
Where it is running
1 location listed.
- Henan Cancer Hospital - Zhengzhou, Henan, China