RC48-ADC in HER2-low Advanced Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831878
• Other study ID #: LY2023-054-B
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: August 2026

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Wenjin Yin, M.D.
• Phone: 86(21)68385569
• Email: yinwenjin[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Disitamab vedotin
2.0mg/kg, iv, day1, every 2 weeks

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)