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The purpose of this study is to evaluate the efficacy and safety of PD-L1 inhibitorin in combination with Anlotinib treatment for patients with triple receptor negative breast cancer treated after failure of standard therapy (including Anthracyclines and/or Taxanes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2450 Injection and Anlotinib Hydrochioride Capsules | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 Injection and Anlotinib Hydrochioride Capsules | Drug | TQB2450 1200mg intravenously (IV) every-3-weeks (Q3W) and Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate(ORR) | Overall Response Rate (ORR) defined as the proportion of subjects who achieves a best response of CR or PR, assessed by IRC per the Lugano Classification | Up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) | Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis). | Up to 96 weeks |
| Overall Survival (OS) |
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Inclusion Criteria:
- 1、18 and 75 years old; ECOG physical condition: 0 - 1 points; expected survival time more than 3 months。 2、Histological or cytological diagnosis of relapsed/metastatic triple receptor negative breast cancer (TNBC).TNBC is defined negatively expression of estrogen(ER), progesterone(PR) and human epidermal receptor-2(HER2).If there is a pathology report of the metastasis, take the histopathology of the metastases as standard. Negative of ER and PR is defined as expression of ER,PR<1% of the tumor cells by immunohistochemistry (IHC). HER2-negative is defined as a score of 0 and 1+ by IHC, or IHC 2+ & fluorescent in situ hybridization (FISH)negative. If the ER2 test result is 0 or 1+ by IHC, FISH detection is optional, but the result must be negative.
3、Patients had at least one measurable lesion (RECIST 1.1); 4、Participants has received prior anthracyclines and/or taxanes in first-line therapy. Disease progressed after latest chemotherapy. For adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy.
5、Subject must have adequate organ functions and meet requirements on laboratory values.:Count of Blood Cells:hemoglobin content(HB)≥80g/L(No blood transfusion was performed within 14 days); absolute neutrophil count (ANC) ≥ 1.5 × 10^9 / L; platelet count (PLT) ≥ 75 × 10^9 / L;; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN,with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) , Biochemical examination: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), with the exception of patients with Gilbert's syndrome(TBIL≤3×ULN) ; serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance rate>50 μmol/L;Blood coagulation function:Prothrombin time(PT)≤1.5×ULN、International standardized ratio(INR)≤1.5×ULN、Activation partial thrombin time(APTT)≤1.5×ULN、Prothrombin time≤1.5×ULN;Doppler ultrasound evaluation:Left ventricular ejection fraction(LVEF)≥50%×ULN. 6、Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug and should agree to use an adequate method of contraception starting with the first dose of study therapy through 8 weeks after the last dose of study therapy.Men enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 8 weeks after the last dose of study therapy; 7、Subject has voluntarily agreed to participate by giving written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binhe Xu, doctor | Contact | xubinghe@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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From the first dose of TQB2450 to the date of death
| Up to 96 weeks |
| Duration of Response (DCR) | The percentage of cases with remission (PR+CR) and stable disease (SD) after treatment in the evaluable cases | Up to 96 weeks |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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