Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
Female patients aged between 18 and 75 years old.
With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Blood routine: Absolute neutrophil count (ANC) > 1.5×10⁹/L; platelet count (PLT) > 75× 10⁹/L; hemoglobin (Hb) > 90 g/L; lymphocyte count ≥ 1.5×10⁹/L.
Blood biochemistry: Total bilirubin (TBIL) < 1.5× the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5×ULN; alkaline phosphatase < 2.5×ULN; blood urea nitrogen/urea (BUN/UREA) and creatinine (Cr) < 1.5×ULN.
Stage IV breast cancer.
Inflammatory breast cancer.
Have previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma.
Simultaneously receiving anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone-modifying drug therapy, or immune checkpoint inhibitor therapy.
Parallel
Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart
DrugGroup A: Epirubicin + cyclophosphamide + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by nab-paclitaxel + Benmelstobart administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is simultaneously combined. It is taken orally once a day, before breakfast. Take the medicine continuously for two weeks, then stop taking it for one week. One cycle is 21 days, and there are a total of 3 cycles. Group B: Nab-paclitaxel + Benmelstobart are administered by intravenous drip once every 3 weeks for a total of 2 cycles, followed by Epirubicin + cyclophosphamide + Benmelstobart, which are administered by intravenous drip once every 3 weeks for a total of 2 cycles. During the treatment period, Anlotinib is also used in combination. It should be taken orally once a day before breakfast, continuously for two weeks, then stop taking it for one week.
pathologic complete response（PCR）
The primary study objective is to evaluate the pathologic complete response（PCR） of neoadjuvant treatment of HR+/HER2- breast cancer with Anlotinib and Benmelstobart
RCB 0-1 Ratio
In clinical trials comparing different neoadjuvant treatment regimens, the RCB 0 - 1 Ratio is a crucial evaluation indicator. For example, in a study comparing a traditional chemotherapy regimen with a novel targeted combination chemotherapy regimen, by observing the differences in the RCB 0 - 1 Ratio between the two groups of patients, it can be determined which regimen enables more patients to reach the RCB 0 or RCB 1 status, thus providing a basis for selecting a better treatment option.
Event Free Survival（EFS)
Event Free Survival (EFS) refers to the time from the start of randomization (the start of treatment in a single-arm trial) to the first occurrence of any of the following events: disease progression that makes surgical treatment impossible, local or distant recurrence, death due to any cause, etc. It can be used to evaluate the effectiveness of the drug.
Click on the lead sponsor to view all of their trials.
