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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    366
  • sponsor
    RemeGen
Updated on 14 March 2021

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.

Description

This study is a multi-center, randomized, open, parallel control to evaluate the effectiveness and safety of Phase III clinical trials of the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of locally advanced or metastatic breast cancer the study.The low expression of HER2 is defined as: the immunohistochemistry (IHC) confirmed by the central laboratory detects the expression of HER2 protein as IHC 2+ and the fluorescence in situ hybridization (FISH) detection has no amplification.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Paclitaxel injection, RC48-ADC, Capecitabine tablets, Docetaxel Injection, Vinorelbine Tartrate Injection
Clinical Study IdentifierNCT04400695
SponsorRemeGen
Last Modified on14 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 1.5109/L; white blood cell count
0109/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
phosphataseALP 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 1.5ULN, 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
The low expression of HER2 confirmed by the IHC and FISH results of the central laboratory (defined as: IHC 2+ and no amplification of FISH); the subject can provide a specimen of the primary or metastatic tumor site (paraffin wax) for HER2 detection Block, paraffin-embedded section or fresh tissue section can be used)
Previous use of anthracycline drugs
Received 1 or 2 systemic chemotherapy treatments after relapse / metastasis. Subjects who relapsed during adjuvant chemotherapy or within 12 months after the end of adjuvant chemotherapy were considered to have failed first-line chemotherapy after relapse / metastasis
Hormone receptors are negative or positive. Hormone receptor-positive subjects need to progress after receiving endocrine therapy after relapse / metastasis or relapse after less than 2 years. Patients who are not suitable for endocrine therapy can be included in this study after undergoing chemotherapy treatment (first-line or second-line)
The imaging evidence confirmed by the investigator that the tumor disease progressed during or after the most recent treatment is required
There has been no diagnosis of HER2 positive (HER2 IHC 3+ or FISH amplification)
Have not used drugs targeting HER2 (including antibodies, small molecule Tyrosine kinase inhibitorTKIs and antibody drug conjugates)
According to the RECIST 1.1 standard, there is at least one measurable lesion

Exclusion Criteria

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 virusHBV 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
Subjects who are not suitable for using any of the alternative control drugs
The presence of brain metastases and / or cancerous meningitis
Have other malignant tumors within 5 years before signing the informed consent form (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumors that have been effectively treated, except malignant tumors that are considered cured)
Subjects who are estimated to be inadequate for patients to participate in this clinical study or other factors that the investigator believes are inappropriate to participate in this study
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