Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC48-ADC | RC48-ADC for breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disitamab vedotin | Drug | recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The time from the date of starting Disitamab Vedotin to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first. | From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0. | From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
breast cancer patients with prior or current use of Disitamab vedotin (RC48-ADC)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjin Yin, M.D. | Contact | 86(21)68385569 | yinwenjin@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenjin Yin, M.D. | Renji Hospital,School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200127 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722994 | disitamab vedotin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |