RC48-ADC in HER2-low Advanced Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.

Official Title
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Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer

Conditions
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Advanced Breast Cancer

Intervention / Treatment
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* Drug: Disitamab vedotin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients aged 18-70 years (including 18 years and 70 years) Expected survival ≥12 weeks ECOG 0-1 Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable At least one measurable lesion according to the RECIST 1.1 No history of antibody-drug conjugate use Up to one previous chemotherapy for advanced disease Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test Adequate organ function Exclusion Criteria: History of thromboembolic events Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc. Active infections requiring systemic treatment Pregnant or lactating Presence of brain metastases and/or carcinomatous meningitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RC48-ADC<br>RC48-ADC as salvage treatment for HER2-low advanced breast cancer | Drug: Disitamab vedotin<br>* 2.0mg/kg, iv, day1, every 2 weeks<br>* Other names: RC48-ADC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year) | 

Secondary Outcome Measures

| Outcome Measure | 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) |