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Trial Title:
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
NCT ID:
NCT05904964
Condition:
HR Positive/HER2 Low Expression Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Disitamab vedotin
Conditions: Keywords:
HR positive
HRE2 low expression
metastatic breast cancer
ADC
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients were randomly assigned to disitamab vedotin or endocrine therapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab vedotin
Description:
Disitamab Vedotin 2mg/kg was injected every 2 weeks,
Arm group label:
Disitamab Vedotin
Other name:
RC48
Intervention type:
Other
Intervention name:
Endocrine therapy
Description:
Doctors choose endocrine therapy independently
Arm group label:
Endocrine therapy
Summary:
Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type
of breast cancer, accounting for about 50% - 60%. However, this type of patients lack
ideal therapeutic drugs after the failure of first-line standard endocrine therapy, and
the median overall survival time is only 30 months. Therefore, finding more efficient and
safe therapeutic drugs for these patients has become a big clinical challenge at present.
Disitamab Vedotin (DV), as a new class I Antibody-Drug Conjugates drug, can achieve high
efficiency and precise tumor killing effect with low toxicity. According to previous
study with same sample size, DV also showed good efficacy in metastatic breast cancer
with Hormone receptor positive and HER2- low expression as a posterior line
treatment.Therefore, we intend to explore the efficacy and safety of DV in the treatment
of HER2-low expressioin /Hormone receptor positive metastatic breast cancer patients with
endocrine resistance through a scientifically designed, randomized, phase III clinical
study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult female patients (aged 18-70 years, including 18 and 70 years) with metastatic
breast cancer confirmed by pathology or imaging are not suitable for surgical
resection or radiotherapy for the purpose of cure;
2. Pathological examination confirmed that ER and / or PR were positive, and HER-2 was
low expression (ER expression: immunohistochemical staining of tumor cells ≥ 10%; PR
expression: immunohistochemical staining of tumor cells ≥ 10%; HER2-low:
immunohistochemical staining of 2 + and FISH is not expanded, IHC 1 +);
3. Patients who have received endocrine therapy ;
4. According to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1,
there is at least one evaluable target lesion or only osteolytic bone metastasis;
5. Patients with stable brain metastasis or asymptomatic brain metastasis;
6. ECOG physical condition score ≤ 2 points, and the estimated survival time is not
less than 3 months;
7. Prior treatment-related toxicity must be relieved to ≤ 1 degree (according to NCI
CTCAE 5.0) before enrollment (except for hair loss or other toxicity that is
considered as no risk to the safety of patients according to the judgment of the
researcher);
8. Adequate bone marrow functional reserve: a. WBC ≥ 3.0 × 10 ^ 9 ／ L, b. Neutrophil
count (ANC) ≥ 1.5 × 10 ^ 9 ／ L, c. Platelet count (PLT) ≥ 70 × 10^9／L;
9. Liver, kidney and heart function tests were basically normal within one week before
enrollment (based on the normal values of laboratories in each research center): A.
total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN), B. alanine
aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), C.
serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; d.
left ventricular ejection fraction (LVEF) ≥ 55%, e. QTcF(Fridericia correction) ≤
470 ms;
10. Patients understand the research process, voluntarily participate in the research,
and sign the informed consent form.
Exclusion Criteria:
1. Patients who had received chemotherapy, radiotherapy, immunotherapy, and endocrine
therapy for breast cancer within 2 weeks before enrollment.;
2. Patients who had performed major surgery within 2 weeks before enrollment.
3. Severe heart disease or discomfort within 12 months, including, but not limited to,
the following: unstable angina pectoris, myocardial infarction, cerebral hemorrhage
and cerebral infarction (except for silent lacunar cerebral infarction without
treatment);
4. Have active autoimmune diseases (such as corticosteroids or immunosuppressive drugs)
requiring systemic treatment in the past 2 years, excluding those with adrenal
insufficiency requiring corticosteroid replacement therapy;
5. Have a clear history of neurological or mental disorders, including epilepsy or
dementia;
6. According to the judgment of the researchers, there are some accompanying diseases
that seriously endanger the safety of patients or affect patients to complete the
study.
7. Those who have been known to have allergic history to Disitamab Vedotin or similar
drugs;
8. According to the estimation of the investigator , the patient's compliance with the
clinical study is insufficient or the researcher believes that there are other
factors that are not suitable for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Wang
Phone:
020-34070870
Email:
wangy556@mail.sysu.edu.cn
Contact backup:
Last name:
Jianli Zhao
Phone:
020-34070499
Email:
zhaojli5@mail.sysu.edu.cn
Facility:
Name:
The Second Affiliated Hospital， Shantou University Medical College
Address:
City:
Shantou
Zip:
515000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiyang Li
Facility:
Name:
Hainan Qionghai People's Hospital
Address:
City:
Qionghai
Zip:
571400
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianbao Wang
Start date:
July 1, 2023
Completion date:
March 1, 2030
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05904964
https://www.nccn.org/professionals/physician_gls/default.aspx
