DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer

NCT06178159 | Recruiting Phase 2

• 1 other identifier: RC48-C026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.

Conditions

Breast Cancer

Keywords

Breast Cancer; HER2-positive

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate (ypT0/is ypN0)

  Pathological complete response rate after neoadjuvant ( both breast and axillary lymph nodes, in which the breast may have residual carcinoma in situ);

  1 month after surgery

Secondary Outcomes (10)

• Objective remission rate (ORR)

  Up to approximately 2 years

• Disease free survival（DFS）

  Up to approximately 5 years

• Event free survival (EFS)

  Up to approximately 5 years

• Overall survival (OS)

  Date of randomization to date of death due to any cause, up to 5 years after the last subject randomized

• Adverse events

  Up to approximately 2 months after surgery

Study Arms (2)

Disitamab Vedotin + Pertuzumab

EXPERIMENTAL

Disitamab Vedotin With Pertuzumab arm

Drug: Disitamab Vedotin Injection; Drug: Pertuzumab Injection

Disitamab Vedotin + Toripalimab+ Pertuzumab

EXPERIMENTAL

Disitamab Vedotin+ Toripalimab with Pertuzumab arm

Drug: Disitamab Vedotin Injection; Drug: Pertuzumab Injection; Drug: Toripalimab

Interventions

Disitamab Vedotin Injection DRUG

2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.

Also known as: DV,RC48-ADC

Disitamab Vedotin + Pertuzumab; Disitamab Vedotin + Toripalimab+ Pertuzumab

Pertuzumab Injection DRUG

Initial dose 840mg, after 2nd dose 420mg intravenous infusion， every 3 weeks

Disitamab Vedotin + Pertuzumab; Disitamab Vedotin + Toripalimab+ Pertuzumab

Toripalimab DRUG

3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Also known as: JS001

Disitamab Vedotin + Toripalimab+ Pertuzumab

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate and sign the informed consent form;
• Ages≥18 years;
• Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter \> 2 cm), cN0- 3, M0;
• Invasive breast tumour tissue confirmed HER2-positive by the central laboratory, defined as HER2 protein expression of IHC 3+ by immunohistochemistry (IHC) or IHC 2+ with amplification by in situ hybridisation (ISH) (according to the HER2 Guidelines for Breast Cancer, 2019 edition); and specimens from the primary site of the tumour for HER2 testing (wax blocks, sections or fresh tissue are acceptable) can be provided for HER2 testing;
• Subjects who tolerate and are scheduled to undergo radical breast cancer surgery and have not received any prior anti-tumour systemic therapy for breast cancer, as assessed by site.
• At least one measurable lesion according to RECIST v1.1 criteria;
• Cardiac function: New York Heart Association (NYHA) class \<3; left ventricular ejection fraction ≥55%;
• Bone marrow or organ function, the following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial centre, no transfusion of blood, haematopoietic stimulating factors, albumin or blood products within 14 days prior to the test): haemoglobin ≥ 90 g/L; absolute neutrophil count (ANC) ≥ 1.5 × 109 /L; platelets ≥ 100 × 109 /L; serum total bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN); Albuminous Transaminase (AST) and Albuminous Transaminase (ALT) ≤ 2.5 × ULN; International Normalised Ratio (INR) and Activated Fractional Thromboplastin Time ≤ 1.5 × ULN; and Creatinine Clearance (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula method;
• Subjects of childbearing potential who meet the following criteria:
• A serum pregnancy test (minimum sensitivity of 25 mIU/mL or equivalent units of β-human chorionic gonadotropin \[β-hCG\]) must be negative within 72 hours prior to the first dose of study intervention. Subjects with false-positive results and confirmed non-pregnancy will be eligible for participation in the study.
• Must agree to contraception for the duration of the study and for at least 6 months after the last dose of study drug (7 months after the last dose of patulizumab).
• Must agree not to breastfeed or donate eggs from the time of signing the informed consent until 6 months after the last dose of study drug (7 months after the last dose of patulizumab).
• If sexually active and likely to result in pregnancy, use of at least 2 acceptable contraceptive methods, at least 1 of which must be highly effective, must be continued from the time of informed consent for at least 6 months after the last dose of study drug (7 months after the last dose of patulizumab).
• Subjects of childbearing potential who meet the following criteria:
• Must agree not to donate sperm from the time of signing the informed consent until at least 4 months after the last dose of study drug (7 months after the last dose of patulizumab).

You may not qualify if:

• With bilateral invasive breast cancer
• Previous history of invasive breast cancer
• Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery
• Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs
• Prior anti-HER2 therapy including but not limited to ADC
• Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration
• Vaccination with live or live attenuated vaccine within 4 weeks prior to the start of study drug administration or planned for the duration of the study;
• History of previous allogeneic haematopoietic stem cell transplantation or organ transplantation;
• Uncontrolled or significant cardiovascular disease, including (but not limited to): any of the following within 6 months prior to the first dose: e.g., congestive heart failure (NYHA class III or IV), myocardial infarction or cerebral infarction (except for lacunar cerebral infarction), pulmonary embolism, unstable angina, or arrhythmia requiring treatment at screening; primary cardiomyopathy (e.g., dilated cardiomyopathy, Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy); history of clinically significant prolongation of the QTc period, grade II type II AV block or grade III AV block or QTc interval (F method) \>470 msec (women) or \>450 msec (men); atrial fibrillation (EHRA grade ≥2b); uncontrolled hypertension that is judged by the investigator to be unsuitable; and Hypertension, judged by the investigator to be unsuitable for participation in the study;
• History of interstitial lung disease requiring treatment or current severe lung disease including, but not limited to, active tuberculosis, interstitial lung disease;
• A clear past or present history of a neurological or psychiatric disorder, including epilepsy or dementia;
• Persistent grade ≥2 sensory or motor neuropathy;
• Active infection requiring systemic therapy; active infection requiring systemic therapy ≤7 days prior to study drug administration, with routine antimicrobial prophylaxis permitted; positive HIV test results; patients with active hepatitis B or C (HBsAg positivity with HBV DNA titres above the upper limit of normal; HCVAb positivity with HCV RNA titres above the upper limit of normal); and persistent coronavirus (COVID-19) infection.
• Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of corticosteroids or immunosuppressive drugs, etc.), allowing for related replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency);
• Other malignancy within 5 years prior to signing the Informed Consent Form (with the exception of non-melanoma skin cancer, cervical carcinoma in situ, limited prostate cancer, stage I endometrial cancer, or other tumours that have been effectively treated and are considered to have been cured);

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

disitamab vedotin; pertuzumab; toripalimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianmin Fang, Ph.D

  RemeGen Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Jianmin Fang, Ph.D

CONTACT

+8610-58075763; Jianminfang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 20, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)