Advanced Breast Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of trastuzumab deruxtecan in advanced breast cancer patients.
Interventions
DRUGTrastuzumab deruxtecan
Trastuzumab deruxtecan is a combination of the targeted cancer drug trastuzumab (also known as Herceptin) and a chemotherapy drug called deruxtecan or DXd.
Sponsors
Wenjin Yin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 and older * Breast cancer patients meeting current guideline recommendations and planning to receive trastuzumab deruxtecan * ECOG 0-1
Exclusion criteria
* During pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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 trastuzumab deruxtecan 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 trastuzumab deruxtecan to the end of the treatment (up to approximately 1 year) | Adverse events during trastuzumab deruxtecan will be assessed according to the NCI CTCAE v5.0. |
Countries
China
Contacts
Primary ContactWenjin Yin, M.D.
Outcome results
None listed