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The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody(SCT200)in patients with triple receptor negative breast cancer treated after failure of standard therapy (including Anthracyclines and/or Taxanes).
This open label,single-arm multicenter phase II study is designed to evaluate Objective Response Rate (ORR) in advanced triple receptor negative breast cancer treated with anti-EGFR monoclonal antibody SCT200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT200 | Experimental | Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT200 | Biological | Recombinant Anti-EGFR Monoclonal Antibody(SCT200) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | AE are assessed according to NCI CTCAE v4.03. | 1 year |
| Progress Free Survival ( PFS) | PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria. |
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Inclusion Criteria:
Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.
-Females: Post-menopausal, surgically sterile, non-pregnant and non-lactating.Women of childbearing potential must not be pregnant as assessed by a negative serum beta HCG test drawn upon admission to the hospital or up to 7 days prior to admission, and must agree to use adequate contraception (Oral contraceptives; intrauterine deviceshormonal; barrier method of birth control; abstinence) for the duration of study participation.and within 6 months after study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qingyuan zhang, MD | Contact | 0086-451-86298276 | sy86298276@163.com |
| Name | Affiliation | Role |
|---|---|---|
| qingyuan zhang, MD | Cancer Hospital Affiliated to Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Affiliated to Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 1 year |
| Duration of response (DOR) | DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first. | 1 year |
| Disease control rate (DCR) | The achievement of any a stable response(SD), partial response (PR) or complete response (CR), according to RECIST v1.1 criteria. | 1 year |
| Time to Progression (TTP) | TTP is defined as the time from first dose of SCT200 until the date of first documentation of progressive disease (PD), according to RECIST v1.1 criteria. | 1 year |
| Overall survival (OS) | OS is defined as time from first dose of SCT200 until the date of death from any cause. | 1 year |