Trastuzumab Deruxtecan in Advanced Breast Cancer
ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWenjin Yin
About this trial
To evaluate the efficacy and safety of trastuzumab deruxtecan in advanced breast cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 and older
Breast cancer patients meeting current guideline recommendations and planning to receive trastuzumab deruxtecan
ECOG 0-1
Disqualifiers
During pregnancy and lactation
Trial population
Breast cancer patients meeting current guideline recommendations and planning to receive trastuzumab deruxtecan
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Trastuzumab deruxtecan
DrugTrastuzumab deruxtecan is a combination of the targeted cancer drug trastuzumab (also known as Herceptin) and a chemotherapy drug called deruxtecan or DXd.
Treatment groups
118 Participants
are divided into 1 treatment groupGroup A: Trastuzumab deruxtecan1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
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.
Time frame
From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)Secondary outcomes
1
Adverse events
Adverse events during trastuzumab deruxtecan will be assessed according to the NCI CTCAE v5.0.
Time frame
From the date of starting trastuzumab deruxtecan to the end of the treatment (up to approximately 1 year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wenjin Yin
Lead sponsor
RenJi Hospital
Sponsor institution
Source ClinicalTrials.gov