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This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer.
Participants must have HER2-low and PD-L1 positive (CPS≥1)breast cancer that has been treated before.
Participants' cancer:
Cannot be removed by an operation Has spread to other parts of the body
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), Anlotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib | Drug | Tucidinostat (chidamide),30mg, po., biw PD-1 inhibitor (tislelizumab), 200mg, ivgtt. d1, q3w anlotinib, 12mg, po., d1-14, q3w |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Time from treatment until disease progression or death | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Objective Response Rate(ORR)by RECIST 1.1,the total proportion of patients with complete response(CR), partial response(PR) | 2 years |
| Clinical Benefit Rate (CBR) | the total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months |
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Inclusion Criteria:
Has pathologically documented breast cancer that:
Has documented radiologic progression (during or after most recent treatment)
Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)
Exclusion Criteria:
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| 2 years |
| Disease Control Rate (DCR) | the total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD) | 2 years |
| Overall survival (OS) | Time from treatment until death from any cause | 2 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000082082 | Immune Checkpoint Inhibitors |
| C000707970 | tislelizumab |
| C000625192 | anlotinib |
| 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 |
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