Breast Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.
Interventions
DRUGDisitamab vedotin
recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks
Sponsors
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed breast cancer; * Prior or current use of Disitamab vedotin (RC48-ADC);
Exclusion criteria
* Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year) | Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0. |
Countries
China
Contacts
Primary ContactWenjin Yin, M.D.
Outcome results
None listed