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

NCT06389006 | Recruiting Phase 2

• 1 other identifier: RC48-C025
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

Breast Cancer; HR-positive; HER2 low-expressing

Outcome Measures

Primary Outcomes (1)

• Total pathological complete response (tpCR) rate

  Defined as the proportion of participants with a pathological assessment of pCR (ypT0/Tis, ypN0) in the analyzed population

  1month after surgery

Secondary Outcomes (10)

• Breast pathological complete response（bpCR）

  1 month after surgery

• Event free survival (EFS)

  Up to approximately 3 or 5 years

• Disease-free survival (DFS)

  Up to approximately 3 or 5 years

• Objective Response Rate (ORR)

  Baseline to surgery

• Adverse events (AEs)

  Up to approximately 2 months after surgery

Study Arms (1)

Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）

EXPERIMENTAL

Disitamab Vedotin combined with Toripalimab sequential chemotherapy arm

Drug: Disitamab Vedotin for Injection; Drug: Toripalimab; Drug: Epirubicin; Drug: Cyclophosphamide

Interventions

Disitamab Vedotin for Injection DRUG

2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed

Also known as: RC48

Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）

Toripalimab DRUG

3.0 mg/kg, intravenous infusion, D1, every 2 weeks, every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks,every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.

Also known as: JS001

Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）

Epirubicin DRUG

According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed.

Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）

Cyclophosphamide DRUG

According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks , Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed

Also known as: CTX

Disitamab Vedotin combined with Toripalimab sequential chemotherapy（Epirubicin +CTX）

Eligibility Criteria

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

You may qualify if:

• 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:
• New York Heart Association (NYHA) Grade \< 3;
• left ventricular ejection fraction ≥50%;
• Bone marrow or organ function should meet the following criteria within 7 days before the study dose:
• Hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet ≥ 100 ×109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); Aspartate aminotransferase (AST) and glutamic pyruvic transaminase (ALT) ≤ 2.5 times the upper limit of normal value; International normalized ratio (INR) and activated partial thrombin time ≤ 1.5×ULN; Serum creatinine ≤ 1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL/min according to Cockcroft-Gault formula method;
• Fertile female subjects who meet the following conditions

You may not qualify if:

• 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;
• Have active autoimmune diseases requiring systemic treatment within the past 2 years, allowing for relevant replacement therapy;
• Have a clear past or present history of neurological or psychiatric disorders, including epilepsy or dementia;
• Persistent ≥ grade 2 sensory or motor neuropathy;
• In the judgment of the investigator, there is a serious concomitant disease that endangers the safety of the subject or interferes with the completion of the clinical study;
• Positive HIV test result; Patients with active hepatitis B or C; Persistent coronavirus (COVID-19) infection;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Jiong Wu

Shanghai, Fudan University Shanghai Cancer Center, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

disitamab vedotin; Injections; toripalimab; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Leng Kang

  RemeGen Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Leng Kang

CONTACT

+8610-58075763; kang.leng@remegen.com

Study Design

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

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: April 29, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)