Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Who is this study for? Patients with Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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;

• 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 inhibitor(TKIs) and antibody drug conjugates).

• According to the RECIST 1.1 standard, there is at least one measurable lesion.

Locations
Other Locations
China
Oncology Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Binghe Xu, M.D.
bhxu@hotmail.com
010-87788826
Time Frame
Start Date: 2020-09-29
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 366
Treatments
Experimental: RC48-ADC
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.
Active_comparator: Physician's Choice
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
Authors
Related Therapeutic Areas
Sponsors
Leads: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov