RC48-ADC in HER2-low Advanced Breast Cancer
ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRenJi Hospital
About this trial
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged ≥18 years
Expected survival ≥12 weeks
ECOG 0-1
Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
Disqualifiers
History of thromboembolic events
Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
Active infections requiring systemic treatment
Pregnant or lactating
Trial design
Design model
Single group
Treatments tested in this trial
Disitamab vedotin
Drug2.0mg/kg, iv, day1, every 2 weeks
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: RC48-ADCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
The percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people.Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
Time frame
From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)Secondary outcomes
1
Adverse events
Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.
Time frame
From the date of starting Disitamab Vedotin to the end of the treatment (up to approximately 1 year)Sponsors and contacts
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Source ClinicalTrials.gov