HER2-positive Breast Cancer
Conditions
Keywords
SHR-A1811, Pyrotinib, HER2-positive Breast Cancer, Neoadjuvant
Brief summary
This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Interventions
DRUGSHR-A1811
SHR-A1811
DRUGPyrotinib
Pyrotinib
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Shengjing Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged ≥ 18 but ≤ 75 years * Histologically confirmed to be HER2-positive invasive breast cancer * Treatment-naive patients with stage II-III * Eastern Cooperative Oncology Group (ECOG) score 0-1 * Good level of organ function
Exclusion criteria
* Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) * Received any other anti-tumor therapy at the same time * Bilateral breast cancer, inflammatory breast cancer or occult breast cancer * Stage IV breast cancer * With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer * Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption * Participated in other drug clinical trials within 4 weeks before enrollment * History of allergies to the drug components of this protocol * Clinically significant pulmonary diseases * Clinically significant cardiovascular diseases * History of immunodeficiency * Active hepatitis and liver cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response (tpCR: ypT0-is/ypN0) | At the time of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual cancer burden (RCB) | At the time of surgery | — |
| Best overall response rate (BORR) | During 18 weeks of the neoadjuvant treatment | — |
| Overall survival (OS) | 5 years | — |
| Breast pathological complete response (bpCR：ypT0-is) | At the time of surgery | — |
| Event-free survival (EFS) | 5 years | — |
| Health-related quality of life (HRQOL) (EORTC QLQ-C30) | During 18 weeks of the neoadjuvant treatment | The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30) |
| Health-related quality of life (HRQOL) | During 18 weeks of the neoadjuvant treatment | The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL. |
| Disease-free survival (DFS) | 5 years | — |
Countries
China
Contacts
Primary ContactNan Niu, MD
Outcome results
None listed