The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. The main questions it aims to answer are:
Is Adebrelimab plus chemotherapy better than T-EC chemotherapy alone in neoadjuvant setting of HR+/HER2-low early stage population? Is SHR-A1811-EC plus Adebrelimab better than T-EC chemotherapy and/or Adebrelimab plus chemotherapy
Participants will:
Take 8 cycles of standard chemotherapy at day1, every 3 weeks cycle(standard care), or take 8 cycles of adebrelimab plus standard chemotherapy at day 1, every 3 weeks cycle(experimental 2), or take 4 cycles of SHR-A1811 and Adebrelimab at day 1, every 3 weeks cycle, then 4 cycles of adebrelimab plus EC chemotherapy at day 1, every 3 weeks cycke(experimental 1).
Visit the clinic once every 6 weeks at neoadjuvant period for tumor assessment. Take surgery after completion of 8 cycles of neoadjuvant therapy and assess the pathological response. Then, visit the clinic once every 12 weeks at first year and then every 6 months for tumor assessment.
ECOG score: 0-1;
Pathologically confirmed invasive breast cancer, with tumor stage T1c-T2, cN1-2 or T3-4 cN0-2;
HR positive/HER2 low expression(defined as HER2 IHC 1+/2+, FISH negative);
Known PD-L1 expression status, or sufficient tumor tissue for PD-L1 testing;
Inflammatory breast cancer;
Previously received anti-tumor therapy or radiotherapy for any malignant tumor(not including cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma);
Concurrently received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
Within 4 weeks before enrollment, underwent major surgical procedures unrelated to breast cancer, or the patient has not fully recovered from such procedures;
Parallel
SHR-A1811
DrugAn anti-HER2 ADC injection, administered on day 1 of each cycle, with one cycle every 3 weeks. 4.8mg/kg or 5.6mg/kg IV, according to the outcomes of the safety run in process.
Adebrelimab (PD-L1 inhibitor)
DrugA PD-L1 inhibitor, 1200mg IV, is administered on the 1st day of every 3 weeks cycle.
Taxane Chemotherapy
DrugCould be paclitaxel, docetaxel or Nab-paclitaxel, according to physician's choice.
Anthracycline & Cyclophosphamide treatment scheme
DrugAnthracycline usually use epirubicin, 90-100mg/m2, combine with Cyclophosphamide 600mg/m2, both use at day 1, every 3 weeks cycle.
tpCR(ypT0/Tis ypN0M0)
total pathological complete response, define as ypT0/Tis ypN0 M0 assessed according to the AJCC staging criteria
EFS
event free survival, defined as the time from randomization to disease progression that precluded surgery, local or distant recurrence, second primary cancer or death due to any cause, whichever occurred first.
OS
overall survival, define as the time from randomization to death due to any cause.
Adverse Events
The safety assessment includes the categories and incidence rates of adverse events, as well as the severity grade according to CTCAE 6.0
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This trial is not recruiting at the moment. You can still explore other options:
