A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

RemeGen Co., Ltd.1 site in 1 country79 target enrollmentApril 29, 2024

ConditionsBreast Cancer

InterventionsDisitamab Vedotin for Injection Toripalimab Epirubicin Cyclophosphamide

DrugsDisitamab Vedotin for Injection Toripalimab Epirubicin Cyclophosphamide

Overview

Phase: Phase 2
Intervention: Disitamab Vedotin for Injection
Conditions: Breast Cancer
Sponsor: RemeGen Co., Ltd.
Enrollment: 79
Locations: 1
Primary Endpoint: Total pathological complete response (tpCR) rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer

Detailed Description

This is a single-arm, open-label, multicenter phase II clinical trial to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as neoadjuvant treatment in patients with HR-positive, HER2-low breast cancer

Registry

clinicaltrials.gov

Start Date

April 29, 2024

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

RemeGen Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily agree to participate in the study and sign the informed consent;
•Age ≥18 years old (including the threshold value);
•Histologically confirmed invasive breast cancer with clinical stage T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0;
•As assessed by the research Center, the subjects can tolerate and plan to undergo radical surgery for breast cancer and have not previously received any anti-tumor systemic therapy for breast cancer;
•Invasive breast tumor tissue with low HER2 expression confirmed by the central laboratory is defined as IHC 1+ or IHC 2+ expression of HER2 protein detected by immunohistochemistry (IHC), and no amplification detected by in situ hybridization (ISH) (according to the Breast Cancer HER2 Detection Guidelines 2019); Primary tumor specimens (wax pieces, slices or fresh tissues) can be provided for HER2 detection;
•According to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2020 guidelines, tumor tissue estrogen receptor (ER) and progesterone receptor (PgR) expression ≥ 1%;
•Histological grade (Nottingham grading system) G3 or G2 with ER expression
•ECOG physical status 0 or 1;
•At least one measurable lesion according to RECIST v1.1 standard;
•Heart function:

Exclusion Criteria

•Bilateral invasive breast cancer;
•Previous history of invasive breast cancer;
•Previously had carcinoma in situ of the breast and received adjuvant endocrine therapy within 5 years of surgery;
•Use of the investigational drug or major surgery within 4 weeks prior to study dosing;
•Have received or plan to receive live or attenuated vaccine within 4 weeks before the start of study dose;
•Previous history of receiving allogeneic hematopoietic stem cell transplantation or organ transplantation;
•Previous treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other Antibody-Drug Conjugates;
•Uncontrolled or significant cardiovascular and cerebrovascular diseases
•Presence of other treatable or serious lung diseases, including but not limited to active tuberculosis, interstitial lung disease, etc.;
•Suffering from an active infection that requires systematic treatment;