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A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Primary Purpose

Breast Neoplasms, Breast Diseases, Capecitabine

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RC48-ADC
Lapatinib
Capecitabine
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for the first phase randomized control period:

  • Voluntarily agree to participate in the study and sign the informed consent form.
  • Subjects aged 18 - 70 years (inclusive), and the subject who have not reached the age of 71 years old will be considered to be ≤ 70 years of age.
  • Expected survival ≥ 12 weeks.
  • ECOG PS score 0 or 1.
  • Female subjects should be surgically sterilized or in post-menopausal status, or agree to use at least one medically accepted contraceptive methods (such as intrauterine device, contraceptive drug or condom) during study treatment period and for up to 6 months after the study treatment is completed, and the blood pregnancy test must be negative within 7 days prior to study enrollment, and they must not be lactating. For male subjects: all the subjects should be surgically sterilized or agree to use one of the medically approved contraceptive methods during the study treatment period and for an additional of 6 months after the end of the study treatment period.
  • Able to understand study requirements, willing and able to comply with study protocol and follow-up procedures.

With Adequate Organ Function

  • Bone marrow function:

Hemoglobin ≥ 9 g/dL; Absolute neutrophil count ≥ 1.5×109/L; Platelets ≥ 100 × 109/L;

  • Liver function (based on the normal values specified by study site):

Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN in the absence of liver metastases, while ALT, AST and ALP ≤ 5 × ULN in the presence of liver metastases;

  • Renal function (based on the normal values specified by study site):

Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL/min as calculated by Cockcroft-Gault formula, or 24-hour urine Crcl ≥ 60 mL/min;

  • Cardiac function:

New York Heart Association (NYHA) classification < Grade III; Left ventricular ejection fraction ≥ 50%; Tumor Related Criteria

  • Histologically and/or cytologically confirmed invasive locally advanced or metastatic breast cancer that is incurable and unresectable;
  • Positive HER2 expression (positive defined as: IHC 3+ or FISH+); previous test results of HER2 expression provided by the subjects (have to be confirmed by the investigator) and those obtained from the study site or the central laboratory were both acceptable; subject are able to provide samples from primary or metastatic tumor sites for HER2 test (either paraffin blocks, paraffin-embedded sections, or sections prepared using freshly excised tissues);
  • With prior taxane therapy (monotherapy or in combination with other drugs, treatment duration should be ≥ 2 cycles);
  • With prior adjuvant therapy, have received treatment with trastuzumab or its biosimilar for patients with locally advanced cancer or metastasis during relapse and metastasis (monotherapy or in combination with other drugs, such as for ≥ 3 months in the adjuvant therapy phase, and ≥ 6 weeks in the post-relapse and metastatic phase);
  • With evidence of tumor progression during or after the most recent treatment as confirmed by the investigator or with documented history;
  • No more than 2 lines of chemotherapy received after relapse/metastasis. The number of chemotherapy lines is restricted to chemotherapeutic drugs, and each chemotherapy regimen is counted as a number of chemotherapy line, excluding targeted drugs and/or endocrine drugs; the same maintenance treatment as the previous chemotherapy regimen will not be counted.
  • With at least one measurable lesion per RECIST v1.1.

Exclusion Criteria for Randomized Controlled Period in Stage I:

  • Use of investigational drugs within 4 weeks prior to study treatment;
  • Have received major surgeries within 4 weeks prior to study treatment and have not recovered yet;
  • Have received a live vaccine inoculation within 4 weeks prior to the start of study drug administration or was scheduled to receive any vaccine during the study;
  • Have experienced arterial/venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism within 1 year prior to the initiation of study treatment;
  • Suffering uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
  • Currently suffering from active infections requiring systemic treatment;
  • With history of active tuberculosis;
  • With positive HIV test result;
  • Patients with active hepatitis B or C (HBsAg positive and HBV DNA positive; HCVAb positive);
  • Presence of effusion in the third space (including massive hydrothorax or ascites) that cannot be controlled by drainage or other methods;
  • With known hypersensitivity or delayed-type hypersensitivity to certain components of RC48-ADC, capecitabine, lapatinib or similar drugs;
  • With pre-existing gastrointestinal disorders that may affect absorption, such as ileus, ulcerative colitis, chronic diarrhea, inability to swallow, and other conditions that may affect drug administration and absorption;
  • With known psychiatric disorders or drug abuse disorders that might have an impact on compliance with protocol requirements;
  • Have any other diseases, metabolic disorders, abnormal physical examination findings or abnormal laboratory test results, which, judged by the investigator, are reasonably to suspect a disease or condition as a contraindication of the study drug, or may interfere the interpretation of the study results in the future, or that put the patient at a high risk;
  • Women who are pregnant or during lactation period or women/men with childbearing plans;
  • Subjects who are estimated to have poor compliance with the clinical study or the investigator determines that there are other factors not appropriate to participate in the study;
  • Presence of brain metastases and/or carcinomatous meningitis.
  • Had any other malignancy within 5 years prior to signing of the informed consent (except for non-melanoma skin cancer, cervix carcinoma in situ or other tumor that have been effectively treated and considered to be cured);
  • Have received prior chemotherapy, radiotherapy, immunotherapy within 4 weeks prior to the first dose of the study drug;
  • Have received hormonal therapy for breast cancer within 2 weeks prior to the start of study treatment;
  • Patients who received palliative radiotherapy for bone metastases within 2 weeks before the start of study treatment;
  • Have received anti-tumor traditional Chinese medicine within 2 weeks prior to the start of study treatment;
  • Have received capecitabine within 6 months prior to the start of study treatment, or have failed to respond to prior treatment with capecitabine (including progression while on capecitabine treatment or maintenance of clinical efficacy for a period of less than 6 months after treatment), or with intolerance to capecitabine. Patients who have received capecitabine as adjuvant therapy and have discontinued this therapy for ≥ 6 months are eligible;
  • The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 4.03] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator;
  • With prior systemic therapy with or participation in clinical studies with HER2 tyrosine kinase inhibitors (TKIs);
  • With prior treatment with T-DM1 or had participated in clinical studies with same class of drugs.
  • With known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency.

Inclusion Criteria for Stage 1 Cross-over Period:

  • Had previously participated in the study of randomized controlled period and received lapatinib plus capecitabine, and received no anti-tumor treatment after disease progression (RECIST v1.1 criteria);
  • The general situation part refers to the selection criteria of the first stage randomized control period.

Exclusion Criteria for Cross-over Period in Stage I:

  • Have received major surgeries within 4 weeks prior to study treatment and have not recovered yet;
  • Have received a live vaccine inoculation within 4 weeks prior to the start of study drug administration or was scheduled to receive any vaccine during the study (except the COVID-19 vaccine);
  • Have experienced arterial/venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism within 1 year prior to the initiation of study treatment;
  • Suffering uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
  • Currently suffering from active infections requiring systemic treatment;
  • With positive HIV test result;
  • Patients with active hepatitis B or C (HBsAg positive and HBV DNA positive; HCVAb positive);
  • Presence of effusiona in the third space (including massive hydrothorax or ascites) that cannot be controlled by drainage or other means;
  • With known hypersensitivity or delayed-type hypersensitivity to certain components of RC48-ADC or similar drugs;
  • With known psychiatric disorders or drug abuse disorders that might have an impact on compliance with protocol requirements;
  • Have any other diseases, metabolic disorders, abnormal physical examination findings or abnormal laboratory test results, which, judged by the investigator, are reasonably to suspect a disease or condition as a contraindication of the study drug, or may interfere the interpretation of the study results in the future, or that put the patient at a high risk;
  • Women who are pregnant or in lactation period or women/men with childbearing plans;
  • Subjects who are estimated to have poor compliance with the protocol of this cross-over period or the investigator determines that there are other factors not appropriate to participate in the study;
  • Presence of brain metastases and/or carcinomatous meningitis. Have received prior treatment for brain metastases may be considered for participating in this study, provided that the diseases were stable, had no disease progression as confirmed by imaging examinations within 4 weeks prior to the first dose of the investigational product (IP), and that all neurological symptoms have recovered to baseline level without any evidence of newly emerging or spread brain metastases; moreover, treatment with radiation, surgery or steroids was discontinued at least 14 days prior to the first dose of study drug. This exception did not include cancerous meningitis, which should be excluded regardless of the stability of its clinical status;
  • Patients who received palliative radiotherapy for bone metastases within 2 weeks before the start of study treatment;
  • Received treatment with lapatinib and/or capecitabine within 2 weeks prior to the first dose of the study drug;
  • The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 4.03] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator;

Inclusion Criteria for Randomized Controlled Period in Stage II:

  • The general situation part refers to the selection criteria of the first stage randomized control period.

Exclusion Criteria for Randomized Controlled Period in Stage II:

  • The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 5.0] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator;
  • The remaining parts refer to the exclusion criteria of the first stage randomized control period.

Inclusion Criteria for Cross-over Period in Stage II:

  • Had previously participated in the study of randomized controlled period and received lapatinib plus capecitabine, and received no anti-tumor treatment after disease progression (RECIST v1.1 criteria);
  • Expected survival ≥ 12 weeks;
  • ECOG PS score 0 or 1;
  • Female subjects should be surgically sterilized or in post-menopausal status, or agree to use at least one medically accepted contraceptive methods (such as intrauterine device, contraceptive drug or condom) during study treatment period and for up to 6 months after the study treatment is completed, and the blood pregnancy test must be negative within 7 days prior to study enrollment, and they must not be lactating. For male subjects: all the subjects should be surgically sterilized or agree to use one of the medically approved contraceptive methods during the study treatment period and for an additional of 6 months after the end of the study treatment period.
  • Able to understand study requirements, willing and able to comply with study protocol and follow-up procedures.

With Adequate Organ Function

  • Bone marrow function:

Hemoglobin ≥ 9 g/dL; Absolute neutrophil count ≥ 1.5×109/L; Platelets ≥ 100 × 109/L;

  • Liver function (based on the normal values specified by study site):

Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN in the absence of liver metastases, while ALT, AST and ALP ≤ 5 × ULN in the presence of liver metastases;

  • Renal function (based on the normal values specified by study site):

Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL/min as calculated by Cockcroft-Gault formula, or 24-hour urine Crcl ≥ 60 mL/min;

  • Cardiac function:

New York Heart Association (NYHA) classification < Grade III; Left ventricular ejection fraction ≥ 50%;

Exclusion Criteria for Cross-over Period in Stage II:

  • The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 5.0] Grade 0-1, with the following exceptions: a. alopecia; b. pigmentation; c. long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator;
  • The remaining parts refer to the exclusion criteria of the first phase of the crossover period.

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical SciencesRecruiting
  • Liaoning Cancer Hospital & InstituteRecruiting
  • The First Hospital of China Medical UniversityRecruiting
  • An Yang Cancer HospitalRecruiting
  • Beijing Luhe HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Bin Zhou No.1 People's HospitalRecruiting
  • Jilin Cancer HospitalRecruiting
  • The First Hospital Jilin UniversityRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Hunan Cancer HospitalRecruiting
  • The Second Xiyang Hospital of Central South UniversityRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • Heping Hospital Affiliated to Changzhi Medical CollegeRecruiting
  • Affiliated Hospital of Chengde Medical UniversityRecruiting
  • West China Hospital,Sichuan UniversityRecruiting
  • Chongqing University Three gorges HospitalRecruiting
  • The Southwest Hospital of AMURecruiting
  • The Second Hospital of Dalian Medical UniversityRecruiting
  • Fujian Cancer HospitalRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Sun Yat-Sen Memorial HospitalRecruiting
  • The Affiliated Tumor Hospital of Guangzhou Medical UniversityRecruiting
  • Guizhou Cancer HospitalRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • The First Affiliated Hospital of Medical School of Zhejiang UniversityRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Anhui Cancer HospitalRecruiting
  • Anhui Province HospitalRecruiting
  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • The First People's Hospital of JiningRecruiting
  • Yunnan Cancer HospitalRecruiting
  • Linyi Cancer HospitalRecruiting
  • The First Affiliated Hospital of Henan University of Science & TechnologyRecruiting
  • Jiangsu Cancer HospitalRecruiting
  • The Affiliated Tumor Hospital of Guangxi Medical UniversityRecruiting
  • The Second People's Hospital of NeijiangRecruiting
  • Hospital of Qingdao UniversityRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Shanghai Changhai HospitalRecruiting
  • Shanghai Ruijin HospitalRecruiting
  • Cancer Hospital of Shantou University Medical CollegeRecruiting
  • Yue Bei People's HospitalRecruiting
  • The Fourth Hospital of Hebei Medical UniversityRecruiting
  • Tai'an City Central HospitalRecruiting
  • Shanxi Bethune HospitalRecruiting
  • Shanxi Cancer HospitalRecruiting
  • Taizhou Enze Medical CenterRecruiting
  • Tianjin Cancer HospitialRecruiting
  • Weihai Municipal HospitalRecruiting
  • Hubei Cancer HospitalRecruiting
  • Tongji Medical College of HUSTRecruiting
  • Wuhan Union HospitalRecruiting
  • The First Affiliated Hospital of the Fourth Military University of P.L.A.Recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Xing Tai People's HospitalRecruiting
  • The First Affiliated Hospital of Xinxiang Medical UniversityRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • Xuzhou Central HospitalRecruiting
  • Yanbian University HospitalRecruiting
  • Yantai Yuhuangding HospitalRecruiting
  • Yuncheng Central HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RC48-ADC

Lapatinib + Capecitabine

Arm Description

Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.

Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) as Assessed by an IRC
Tumor response was assessed by an IRC according to RECIST v1.1.

Secondary Outcome Measures

Progression-free Survival (PFS) as Assessed by Investigator
Tumor response was assessed by investigator according to RECIST v1.1.
Objective Response Rate (ORR)
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Duration of Objective Response (DOR)
DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier.
Clinical Benefit Rate (CBR)
Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart.
Time to Treatment Failure
Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause.
Overall Survival
OS was defined as the time from the date of randomization to the date of death from any cause.

Full Information

First Posted
April 8, 2018
Last Updated
February 18, 2022
Sponsor
RemeGen Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03500380
Brief Title
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
Official Title
A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Breast Diseases, Capecitabine, HER2-positive Breast Cancer, HER2 Positive Breast Carcinoma, HER2-positive Advanced Breast With Liver Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
301 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RC48-ADC
Arm Type
Experimental
Arm Description
Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Arm Title
Lapatinib + Capecitabine
Arm Type
Active Comparator
Arm Description
Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
Intervention Type
Drug
Intervention Name(s)
RC48-ADC
Other Intervention Name(s)
RC48
Intervention Description
RC48-ADC 2.0 mg/kg IV every 14 days
Intervention Type
Drug
Intervention Name(s)
Lapatinib
Intervention Description
Lapatinib 1250 mg orally once daily during each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by an IRC
Description
Tumor response was assessed by an IRC according to RECIST v1.1.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by Investigator
Description
Tumor response was assessed by investigator according to RECIST v1.1.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Objective Response Rate (ORR)
Description
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Duration of Objective Response (DOR)
Description
DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Clinical Benefit Rate (CBR)
Description
Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Time to Treatment Failure
Description
Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Overall Survival
Description
OS was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
From date of randomization until the date of death from any cause, assessed up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for the first phase randomized control period: Voluntarily agree to participate in the study and sign the informed consent form. Subjects aged 18 - 70 years (inclusive), and the subject who have not reached the age of 71 years old will be considered to be ≤ 70 years of age. Expected survival ≥ 12 weeks. ECOG PS score 0 or 1. Female subjects should be surgically sterilized or in post-menopausal status, or agree to use at least one medically accepted contraceptive methods (such as intrauterine device, contraceptive drug or condom) during study treatment period and for up to 6 months after the study treatment is completed, and the blood pregnancy test must be negative within 7 days prior to study enrollment, and they must not be lactating. For male subjects: all the subjects should be surgically sterilized or agree to use one of the medically approved contraceptive methods during the study treatment period and for an additional of 6 months after the end of the study treatment period. Able to understand study requirements, willing and able to comply with study protocol and follow-up procedures. With Adequate Organ Function Bone marrow function: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count ≥ 1.5×109/L; Platelets ≥ 100 × 109/L; Liver function (based on the normal values specified by study site): Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN in the absence of liver metastases, while ALT, AST and ALP ≤ 5 × ULN in the presence of liver metastases; Renal function (based on the normal values specified by study site): Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL/min as calculated by Cockcroft-Gault formula, or 24-hour urine Crcl ≥ 60 mL/min; Cardiac function: New York Heart Association (NYHA) classification < Grade III; Left ventricular ejection fraction ≥ 50%; Tumor Related Criteria Histologically and/or cytologically confirmed invasive locally advanced or metastatic breast cancer that is incurable and unresectable; Positive HER2 expression (positive defined as: IHC 3+ or FISH+); previous test results of HER2 expression provided by the subjects (have to be confirmed by the investigator) and those obtained from the study site or the central laboratory were both acceptable; subject are able to provide samples from primary or metastatic tumor sites for HER2 test (either paraffin blocks, paraffin-embedded sections, or sections prepared using freshly excised tissues); With prior taxane therapy (monotherapy or in combination with other drugs, treatment duration should be ≥ 2 cycles); With prior adjuvant therapy, have received treatment with trastuzumab or its biosimilar for patients with locally advanced cancer or metastasis during relapse and metastasis (monotherapy or in combination with other drugs, such as for ≥ 3 months in the adjuvant therapy phase, and ≥ 6 weeks in the post-relapse and metastatic phase); With evidence of tumor progression during or after the most recent treatment as confirmed by the investigator or with documented history; No more than 2 lines of chemotherapy received after relapse/metastasis. The number of chemotherapy lines is restricted to chemotherapeutic drugs, and each chemotherapy regimen is counted as a number of chemotherapy line, excluding targeted drugs and/or endocrine drugs; the same maintenance treatment as the previous chemotherapy regimen will not be counted. With at least one measurable lesion per RECIST v1.1. Exclusion Criteria for Randomized Controlled Period in Stage I: Use of investigational drugs within 4 weeks prior to study treatment; Have received major surgeries within 4 weeks prior to study treatment and have not recovered yet; Have received a live vaccine inoculation within 4 weeks prior to the start of study drug administration or was scheduled to receive any vaccine during the study; Have experienced arterial/venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism within 1 year prior to the initiation of study treatment; Suffering uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.; Currently suffering from active infections requiring systemic treatment; With history of active tuberculosis; With positive HIV test result; Patients with active hepatitis B or C (HBsAg positive and HBV DNA positive; HCVAb positive); Presence of effusion in the third space (including massive hydrothorax or ascites) that cannot be controlled by drainage or other methods; With known hypersensitivity or delayed-type hypersensitivity to certain components of RC48-ADC, capecitabine, lapatinib or similar drugs; With pre-existing gastrointestinal disorders that may affect absorption, such as ileus, ulcerative colitis, chronic diarrhea, inability to swallow, and other conditions that may affect drug administration and absorption; With known psychiatric disorders or drug abuse disorders that might have an impact on compliance with protocol requirements; Have any other diseases, metabolic disorders, abnormal physical examination findings or abnormal laboratory test results, which, judged by the investigator, are reasonably to suspect a disease or condition as a contraindication of the study drug, or may interfere the interpretation of the study results in the future, or that put the patient at a high risk; Women who are pregnant or during lactation period or women/men with childbearing plans; Subjects who are estimated to have poor compliance with the clinical study or the investigator determines that there are other factors not appropriate to participate in the study; Presence of brain metastases and/or carcinomatous meningitis. Had any other malignancy within 5 years prior to signing of the informed consent (except for non-melanoma skin cancer, cervix carcinoma in situ or other tumor that have been effectively treated and considered to be cured); Have received prior chemotherapy, radiotherapy, immunotherapy within 4 weeks prior to the first dose of the study drug; Have received hormonal therapy for breast cancer within 2 weeks prior to the start of study treatment; Patients who received palliative radiotherapy for bone metastases within 2 weeks before the start of study treatment; Have received anti-tumor traditional Chinese medicine within 2 weeks prior to the start of study treatment; Have received capecitabine within 6 months prior to the start of study treatment, or have failed to respond to prior treatment with capecitabine (including progression while on capecitabine treatment or maintenance of clinical efficacy for a period of less than 6 months after treatment), or with intolerance to capecitabine. Patients who have received capecitabine as adjuvant therapy and have discontinued this therapy for ≥ 6 months are eligible; The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 4.03] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator; With prior systemic therapy with or participation in clinical studies with HER2 tyrosine kinase inhibitors (TKIs); With prior treatment with T-DM1 or had participated in clinical studies with same class of drugs. With known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency. Inclusion Criteria for Stage 1 Cross-over Period: Had previously participated in the study of randomized controlled period and received lapatinib plus capecitabine, and received no anti-tumor treatment after disease progression (RECIST v1.1 criteria); The general situation part refers to the selection criteria of the first stage randomized control period. Exclusion Criteria for Cross-over Period in Stage I: Have received major surgeries within 4 weeks prior to study treatment and have not recovered yet; Have received a live vaccine inoculation within 4 weeks prior to the start of study drug administration or was scheduled to receive any vaccine during the study (except the COVID-19 vaccine); Have experienced arterial/venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism within 1 year prior to the initiation of study treatment; Suffering uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.; Currently suffering from active infections requiring systemic treatment; With positive HIV test result; Patients with active hepatitis B or C (HBsAg positive and HBV DNA positive; HCVAb positive); Presence of effusiona in the third space (including massive hydrothorax or ascites) that cannot be controlled by drainage or other means; With known hypersensitivity or delayed-type hypersensitivity to certain components of RC48-ADC or similar drugs; With known psychiatric disorders or drug abuse disorders that might have an impact on compliance with protocol requirements; Have any other diseases, metabolic disorders, abnormal physical examination findings or abnormal laboratory test results, which, judged by the investigator, are reasonably to suspect a disease or condition as a contraindication of the study drug, or may interfere the interpretation of the study results in the future, or that put the patient at a high risk; Women who are pregnant or in lactation period or women/men with childbearing plans; Subjects who are estimated to have poor compliance with the protocol of this cross-over period or the investigator determines that there are other factors not appropriate to participate in the study; Presence of brain metastases and/or carcinomatous meningitis. Have received prior treatment for brain metastases may be considered for participating in this study, provided that the diseases were stable, had no disease progression as confirmed by imaging examinations within 4 weeks prior to the first dose of the investigational product (IP), and that all neurological symptoms have recovered to baseline level without any evidence of newly emerging or spread brain metastases; moreover, treatment with radiation, surgery or steroids was discontinued at least 14 days prior to the first dose of study drug. This exception did not include cancerous meningitis, which should be excluded regardless of the stability of its clinical status; Patients who received palliative radiotherapy for bone metastases within 2 weeks before the start of study treatment; Received treatment with lapatinib and/or capecitabine within 2 weeks prior to the first dose of the study drug; The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 4.03] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator; Inclusion Criteria for Randomized Controlled Period in Stage II: The general situation part refers to the selection criteria of the first stage randomized control period. Exclusion Criteria for Randomized Controlled Period in Stage II: The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 5.0] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator; The remaining parts refer to the exclusion criteria of the first stage randomized control period. Inclusion Criteria for Cross-over Period in Stage II: Had previously participated in the study of randomized controlled period and received lapatinib plus capecitabine, and received no anti-tumor treatment after disease progression (RECIST v1.1 criteria); Expected survival ≥ 12 weeks; ECOG PS score 0 or 1; Female subjects should be surgically sterilized or in post-menopausal status, or agree to use at least one medically accepted contraceptive methods (such as intrauterine device, contraceptive drug or condom) during study treatment period and for up to 6 months after the study treatment is completed, and the blood pregnancy test must be negative within 7 days prior to study enrollment, and they must not be lactating. For male subjects: all the subjects should be surgically sterilized or agree to use one of the medically approved contraceptive methods during the study treatment period and for an additional of 6 months after the end of the study treatment period. Able to understand study requirements, willing and able to comply with study protocol and follow-up procedures. With Adequate Organ Function Bone marrow function: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count ≥ 1.5×109/L; Platelets ≥ 100 × 109/L; Liver function (based on the normal values specified by study site): Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN in the absence of liver metastases, while ALT, AST and ALP ≤ 5 × ULN in the presence of liver metastases; Renal function (based on the normal values specified by study site): Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL/min as calculated by Cockcroft-Gault formula, or 24-hour urine Crcl ≥ 60 mL/min; Cardiac function: New York Heart Association (NYHA) classification < Grade III; Left ventricular ejection fraction ≥ 50%; Exclusion Criteria for Cross-over Period in Stage II: The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 5.0] Grade 0-1, with the following exceptions: a. alopecia; b. pigmentation; c. long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator; The remaining parts refer to the exclusion criteria of the first phase of the crossover period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Fang
Phone
+8610-58075763
Email
jianminfang@hotmail.com
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao sun
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuee teng
Facility Name
An Yang Cancer Hospital
City
Anyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Sun
Facility Name
Beijing Luhe Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Yan
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Wang
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Yang
Facility Name
Bin Zhou No.1 People's Hospital
City
Binzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailong Liu
Facility Name
Jilin Cancer Hospital
City
Changchun
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Facility Name
The First Hospital Jilin University
City
Changchun
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Fan
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quchang Ouyang
Facility Name
The Second Xiyang Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enxiang Zhou
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shouman Wang
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengsheng Cui
Facility Name
Affiliated Hospital of Chengde Medical University
City
Chengde
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingshan Li
Facility Name
West China Hospital,Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Yan
Facility Name
Chongqing University Three gorges Hospital
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huawen Liu
Facility Name
The Southwest Hospital of AMU
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhang
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Li
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Liu
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Liao
Facility Name
Sun Yat-Sen Memorial Hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herui Yao
Facility Name
The Affiliated Tumor Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongsheng Li
Facility Name
Guizhou Cancer Hospital
City
Guiyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Ran
Facility Name
Harbin Medical University Cancer Hospital
City
Ha'erbin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peifen Fu
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongchuan Deng
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang
Facility Name
Anhui Cancer Hospital
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changlu Hu
Facility Name
Anhui Province Hospital
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueyin Pan
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangsheng Gu
Facility Name
Qilu Hospital of Shandong University
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuwen Wang
Facility Name
The First People's Hospital of Jining
City
Jining
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Liu
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuangqing Yang
Facility Name
Linyi Cancer Hospital
City
Linyi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Wang
Facility Name
The First Affiliated Hospital of Henan University of Science & Technology
City
Luoyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinshuai Wang
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jifeng Feng
Facility Name
The Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Xie
Facility Name
The Second People's Hospital of Neijiang
City
Neijiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xujuan Wang
Facility Name
Hospital of Qingdao University
City
Qingdao
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Wang
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianbao Zhan
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunwei Shen
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Zeng
Facility Name
Yue Bei People's Hospital
City
Shaoguan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruiwen Lei
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunjiang Liu
Facility Name
Tai'an City Central Hospital
City
Tai'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baojiang Li
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinnan Gao
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinzheng Li
Facility Name
Taizhou Enze Medical Center
City
Taizhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feilin Cao
Facility Name
Tianjin Cancer Hospitial
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong
Facility Name
Weihai Municipal Hospital
City
Weihai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hairong Wang
Facility Name
Hubei Cancer Hospital
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinhong Wu
Facility Name
Tongji Medical College of HUST
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihua Xiong
Facility Name
Wuhan Union Hospital
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Cheng
Facility Name
The First Affiliated Hospital of the Fourth Military University of P.L.A.
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Ling
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Yang
Facility Name
Xing Tai People's Hospital
City
Xingtai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangshun Kong
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liuzhong Yang
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengqiu Zhu
Facility Name
Xuzhou Central Hospital
City
Xuzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Liu
Facility Name
Yanbian University Hospital
City
Yanbian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songnan Zhang
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangming Zhang
Facility Name
Yuncheng Central Hospital
City
Yuncheng
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaofeng Niu
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanting Gu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

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