Actively Recruiting
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-06-22
288
Participants Needed
3
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years with metastatic breast cancer confirmed by pathology or imaging, not eligible for surgery or radiotherapy for cure
- Pathology confirming ER and/or PR positive and HER2-low expression (ER or PR tumor cells 2 10%; HER2 IHC 1+ or 2+ with negative FISH)
- Patients who have received prior endocrine therapy
- At least one evaluable target lesion or only osteolytic bone metastasis according to RECIST 1.1
- Stable or asymptomatic brain metastasis
- ECOG performance status 2 and estimated survival of at least 3 months
- Prior treatment-related toxicity resolved to grade 1 except hair loss or non-safety risk toxicities
- Adequate bone marrow function: WBC 3.0 x10^9/L, ANC 1.5 x10^9/L, platelets 70 x10^9/L
- Normal liver, kidney, and heart function within 1 week before enrollment according to lab standards
- Patients understand and voluntarily consent to participate
You will not qualify if you...
- Chemotherapy, radiotherapy, immunotherapy, or endocrine therapy within 2 weeks before enrollment
- Major surgery within 2 weeks before enrollment
- Severe heart disease or discomfort within past 12 months (e.g., unstable angina, myocardial infarction, stroke)
- Active autoimmune diseases requiring systemic treatment in past 2 years, except adrenal insufficiency on corticosteroid replacement
- History of neurological or mental disorders including epilepsy or dementia
- Serious accompanying diseases risking patient safety or study completion as judged by researchers
- Known allergy to Disitamab Vedotin or similar drugs
- Estimated poor compliance or other factors unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
The Second Affiliated Hospital， Shantou University Medical College
Shantou, Guangdong, China, 515000
Actively Recruiting
3
Hainan Qionghai People's Hospital
Qionghai, Hainan, China, 571400
Actively Recruiting
Research Team
Y
Ying Wang
CONTACT
J
Jianli Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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