RC48-ADC in HER2-low Advanced Breast Cancer

Not Applicable

Recruiting

• Conditions: Advanced Breast Cancer
• Interventions: Drug: Disitamab vedotin

• Registration Number: NCT05831878
• Lead Sponsor: RenJi Hospital

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations
|
Related News

Study Timeline

• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Study First Posted: 2023-04-26
• Status Verified: 2023-05
• Study Start: 2023-05-04
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09
• Primary Completion: 2026-03
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RC48-ADC	Disitamab vedotin	RC48-ADC as salvage treatment for HER2-low advanced breast cancer

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, China