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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: SHR-A1811-EC + Adebrelimab | Experimental | 4 cycles of SHR-A1811 follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles. |
|
| Arm 2: T-EC + Adebrelimab | Experimental | 4 cycles of taxane follow by 4 cycles of EC chemotherapy, with concurrent adebrelimab throughout all 8 cycles. |
|
| Arm 3: T-EC | Active Comparator | 4 cycles of taxane follow by 4 cycles of EC chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 | Drug | An 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. |
| Measure | Description | Time Frame |
|---|---|---|
| tpCR(ypT0/Tis ypN0M0) | total pathological complete response, define as ypT0/Tis ypN0 M0 assessed according to the AJCC staging criteria | After surgery (within 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrollment to completion of 3 years of follow up after surgery |
| OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiqun Li | Contact | +86-010-87788120 | Liyiqun_chcams@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | 100021 | China |
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| Adebrelimab (PD-L1 inhibitor) | Drug | A PD-L1 inhibitor, 1200mg IV, is administered on the 1st day of every 3 weeks cycle. |
|
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| Taxane Chemotherapy | Drug | Could be paclitaxel, docetaxel or Nab-paclitaxel, according to physician's choice. |
|
| Anthracycline & Cyclophosphamide treatment scheme | Drug | Anthracycline usually use epirubicin, 90-100mg/m2, combine with Cyclophosphamide 600mg/m2, both use at day 1, every 3 weeks cycle. |
|
overall survival, define as the time from randomization to death due to any cause. |
| from enrollment to complete of 5 years follow up after surgery |
| 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 | AEs were assessed from enrollment throughout the trial and for 30 days after discontinuation of treatment (90 days for serious AEs) |
| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D018943 | Anthracyclines |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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