RC48-ADC in HER2-low Advanced Breast Cancer

NCT05831878 | Recruiting

• 1 other identifier: LY2023-054-B
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Breast Cancer

Outcome Measures

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.

  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

  From the date of starting Disitamab Vedotin to the end of the treatment (up to approximately 1 year)

Study Arms (1)

RC48-ADC

EXPERIMENTAL

RC48-ADC as salvage treatment for HER2-low advanced breast cancer

Drug: Disitamab vedotin

Interventions

Disitamab vedotin DRUG

2.0mg/kg, iv, day1, every 2 weeks

Also known as: RC48-ADC

RC48-ADC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \>0 but ≤10% of tumor cells
• Adequate organ function

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

disitamab vedotin

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital,School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569; yinwenjin@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 26, 2023
• Study Start: May 4, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: IPD can be accessed from the corresponding author on reasonable request.

Locations

CN (1)