A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

NCT04400695 | Unknown Phase 3 DMC

• 1 other identifier: RC48-C012
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS), evaluated by an independent efficacy evaluation committee

  Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

  within approximately 3 years

Secondary Outcomes (6)

• Progression-free survival (PFS), evaluated by the investigator

  within approximately 3 years

• Objective remission rate (ORR)

  within approximately 3 years

• Duration of relief (DOR)

  within approximately 3 years

• Disease control rate (DCR)

  within approximately 3 years

• Tumor progression time (TTP)

  within approximately 3 years

Study Arms (2)

RC48-ADC

EXPERIMENTAL

RC48-ADC common name：Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection Dosage form：Lyophilized powder injection specification：60 mg / piece Medication plan：Every 2 weeks Expiration date：18 months HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis.

Drug: RC48-ADC

Physician's Choice

ACTIVE COMPARATOR

Physician's Choice: HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis. Physician's choice from the following options: Paclitaxel Injection Docetaxel Injection Vinorelbine Tartrate Injection Capecitabine Tablets

Drug: Paclitaxel Injection; Drug: Docetaxel Injection; Drug: Vinorelbine Tartrate Injection; Drug: Capecitabine Tablets

Interventions

RC48-ADC DRUG

RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks

Also known as: RC48

RC48-ADC

Paclitaxel Injection DRUG

Administered according to label, as one option for Physician's Choice (determined before randomization)

Also known as: Taxol

Physician's Choice

Docetaxel Injection DRUG

Administered according to label, as one option for Physician's Choice (determined before randomization)

Also known as: Taxotere

Physician's Choice

Vinorelbine Tartrate Injection DRUG

Administered according to label, as one option for Physician's Choice (determined before randomization)

Also known as: Navelbine

Physician's Choice

Capecitabine Tablets DRUG

Administered according to label, as one option for Physician's Choice (determined before randomization)

Also known as: Xeloda

Physician's Choice

Eligibility Criteria

• Age: 18 Years - 70 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;
• Subjects aged 18-70 years (including 18 years and 70 years) and not reaching the 71st birthday were all considered to be ≤70 years old;
• Expected survival ≥12 weeks;
• Eastern Cooperative Oncology Group(ECOG) physical condition 0 or 1;
• For female subjects of child-bearing age women agreed to study during treatment and experimental subjects within 6 months after the end of the treatment period using an approved by the medical contraception (e.g. intrauterine device, the pill or condoms), before the study drug delivery within 7 days of pregnancy blood test must be negative (sterilization surgery or age 60 or more subjects can choose no pregnancy blood test), and must be an lactation. For male subjects: should be sterilized surgically, or agree to use a medically approved contraceptive method during the study period and for 6 months after the end of the treatment period. Control subjects after the end of the treatment period according to the choice of control drugs to determine the length of contraception.
• Able to understand the study requirements and be willing and able to follow the study and follow-up procedures.
• Bone marrow function:
• hemoglobin ≥9g/dL; absolute neutrophil count ≥1.5×109/L; white blood cell count ≥3.0×109/L platelet ≥100 ×109/L;
• Liver function (according to the normal value of the clinical trial center) :
• serum total bilirubin ≤1.5 times the upper limit of normal value (ULN); alanine aminotransferase (ALT), aspartate aminotransferase(AST) and Alkaline phosphatase（ALP） were ≤2.5 × ULN in the absence of liver metastasis, and ALT, AST and Alkaline phosphatase(ALP) were ≤5 × ULN in the presence of liver metastasis
• Renal function (according to the normal value of the clinical trial center) :
• serum creatinine ≤1.5×ULN, or calculated by Cockcroft-Gault formula, the creatinine clearance rate (CrCl) ≥60 mL/min;
• Cardiac function:
• American New York college of cardiology (NYHA) grade \< 3; left ventricular ejection fraction ≥50%;
• Breast cancer subjects diagnosed by histology and / or cytology are currently at a locally advanced or metastatic stage and cannot be radically removed;

You may not qualify if:

• Received chemotherapy within 4 weeks before the start of study administration (treatment with nitrosourea and mitomycin C within 6 weeks, oral fluorouracil within 2 weeks), radiotherapy (palliative for bone metastases Local radiotherapy is within 2 weeks before study administration), immunotherapy; received endocrine therapy for breast cancer within 2 weeks before study administration;
• The research drug was used within 4 weeks before the start of study administration;
• Have undergone major surgery within 4 weeks before the start of study administration;
• Have received a live vaccine within 4 weeks before the start of study administration or plan to receive any vaccine during the study period;
• Serious cardiovascular and cerebrovascular events occurred within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except for asymptomatic and untreated lacunar infarction)；
• Those who are suffering from heart disease are not suitable for enrollment, including but not limited to arrhythmia and heart failure requiring medical treatment or accompanied by symptoms;
• There are other lung diseases requiring treatment or serious, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc ;
• Suffering from active infection requiring systemic treatment;
• Have active autoimmune diseases (such as the use of corticosteroids or immunosuppressive drugs, etc.) that require systemic treatment within the past 2 years, allowing related alternative treatments (such as thyroxine, insulin, or the physiology of adrenal or pituitary insufficiency Corticosteroid replacement therapy);
• The toxicity of the previous anti-tumor therapy has not been restored to the 0 to 1 level defined by CTCAE version 5.0, of which the neurotoxicity has not been restored to 0; except for hair loss, pigmentation or other researches that do not increase the risk of medication Happening;
• Have a clear past or current history of neurological or mental disorders, including epilepsy or dementia;
• According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the clinical study；
• Positive HIV test results; patients with active hepatitis B or C (HBsAg positive and hepatitis B virus（HBV） DNA titers above the upper limit of normal; Hepatitis C Virus Antibody(HCVAb) positive hepatitis C virus （HCV） RNA titers above the upper limit of normal)；
• There is a third interstitial fluid that cannot be controlled by drainage or other methods (including a large amount of pleural effusion or ascites);
• Known hypersensitivity or delayed allergic reaction to certain components of RC48-ADC or similar drugs;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Oncology Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Docetaxel; Vinorelbine; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Binghe Xu

  Oncology Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Tao Sun

  Liaoning Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Wei Li

  Jilin University First Hospital

  PRINCIPAL INVESTIGATOR

• Yuee Teng

  First Affiliated Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• Shu Wang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiaojia Wang

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Min Yan

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jifeng Feng

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

• Ying Cheng

  Jilin Provincial Tumor Hospital

  PRINCIPAL INVESTIGATOR

• Ying Wang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Ying Wang

  Sun Yat-sen University Cancer Prevention and Control Center

  PRINCIPAL INVESTIGATOR

• Ning Liao

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Haibo Wang

  Qingdao University Hospital

  PRINCIPAL INVESTIGATOR

• Quchang Ouyang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Yueyin Pan

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Yingying Du

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Changlu Hu

  Anhui Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Zhongsheng Tong

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jin Yang

  The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Lihua Song

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

• Xiuwen Wang

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

• Yu Jiang

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Yunjiang Liu

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

• Jing Cheng

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Huihua Xiong

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Xinhong Wu

  Hubei Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Peng Shen

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Weimin Xie

  Cancer Hospital Affiliated to Guangxi Medical University

  PRINCIPAL INVESTIGATOR

• Xin Zhou

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Li Ran

  Cancer Hospital of Guizhou Province

  PRINCIPAL INVESTIGATOR

• Yu Wang

  Shanxi Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jinnan Gao

  Bethune Hospital of Shanxi Province

  PRINCIPAL INVESTIGATOR

• Jingfen Wang

  Linyi Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Liangming Zhang

  Yantai Yuhuangding Hospital

  PRINCIPAL INVESTIGATOR

• Xianhe Xie

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Ru Zeng

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• Airong Wang

  Weihai Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Zhengqiu Zhu

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

• Sanyuan Sun

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

• Qingshan Li

  Affiliated Hospital of Chengde Medical College

  PRINCIPAL INVESTIGATOR

• Aimin Zang

  Affiliated Hospital of Hebei University

  PRINCIPAL INVESTIGATOR

• Liuzhong Yang

  The First Affiliated Hospital of Xinxiang Medical College

  PRINCIPAL INVESTIGATOR

• Meili Sun

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

• Liang Li

  Zibo Central Hospital

  PRINCIPAL INVESTIGATOR

• Guohua Yu

  Weifang People's Hospital

  PRINCIPAL INVESTIGATOR

• Xujuan Wang

  Neijiang Second People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, M.D.

CONTACT

010-87788826; bhxu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 22, 2020
• Study Start: September 29, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 24, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)