NCT05134519

Brief Summary

This is a single-arm exploratory study to explore the effect of RC48 in HER2-positive neoadjuvant therapy and evaluate the non-inferiority of RC48 by comparing the latest reported data of T-DM1 in neoadjuvant therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

November 26, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

September 23, 2021

Last Update Submit

November 14, 2021

Conditions

Breast CancerHER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response rate (pCR)

    absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0).

    At the end of Cycle 1 (each cycle is 14 days)

Secondary Outcomes (1)

  • adverse effects

    during the period of neadjuvant chemotherapy

Study Arms (1)

RC48 for neadjuvant chemotherapy

EXPERIMENTAL

RC48-ADC: 2.0 mg/kg, IV drip, Q2W

Drug: Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)

Interventions

Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)DRUG

Regimen: RC48-ADC: 2.0 mg/kg, intravenous drip, once every 2 weeks,4-6 cycles

Also known as: RC48
RC48 for neadjuvant chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled were ≥ 18 years of age and \< 80 years of age
  • Female or male breast cancer
  • Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test.
  • Left ventricular score ≥ 55%
  • ECOGPS score 0 or 1
  • Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
  • Adequate organ function

You may not qualify if:

  • cardiac, hepatic, renal, or psychiatric disease history
  • History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

November 26, 2021

Study Start

November 26, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2025

Last Updated

November 26, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share