ER+/HER2- Breast Cancer
Conditions
Keywords
Breast Neoplasms, High-intensity focused ultrasound, PD1, Toripalimab, nab-Paclitaxel, Epirubicin, Cyclophosphamide
Brief summary
The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab plus chemotherapy versus chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.
Detailed description
Study participants will be randomly allocated to either the experimental group or the control group and receive the following treatments. Experimental group: HIFU therapy followed by 8 cycles of neoadjuvant immunotherapy and chemotherapy; Control group: 8 cycles of neoadjuvant chemotherapy alone. Each cycle lasts 21 days. Subsequently, all participants will undergo surgery within 6 weeks after completion of neoadjuvant therapy.
Interventions
PROCEDUREHIFU
HIFU therapy is administered to the targeted breast lesion site.
DRUGToripalimab
240 mg, IV infusion, Q3W
DRUGnab-Paclitaxel (nab-P)
125 mg/m2, IV infusion, QW
DRUGEpirubicin (E)
90 mg/m2, IV infusion, Q3W
600 mg/m2, IV infusion, Q3W
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients aged 18-75 years. 2. Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2. 3. Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion criteria
1. Female patients during pregnancy or lactation. 2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology. 3. Has an active autoimmune disease that has received systemic treatment in the last 2 years. 4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection. 5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years. 7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0 | Up to approximately 30 weeks | The tpCR rate is defined as the proportion of participants with no residual invasive cancer cells in both the breast primary tumor site (residual in situ cancer cells are permitted) and all sampled axillary lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis | Up to approximately 30 weeks | The bpCR rate is defined as the proportion of participants with no residual invasive cancer cells in the breast primary tumor site (residual in situ cancer cells are permitted). |
| Objective Response Rate (ORR) | Up to approximately 30 weeks | ORR is defined as the proportion of participants with a complete or partial response. |
| Event-Free Survival (EFS) | Approximately five years | EFS is defined as the time from randomization to any of the following events: precludes surgery, local or distant recurrence, second primary malignancy, or death due to any cause. |
| Adverse Event (AE) | Approximately three years | An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product, temporally associated with study intervention, without presumption of causality. |
Countries
China
Contacts
Primary ContactYiding Chen
Backup ContactShijie Wu
Outcome results
None listed