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New treatment option for HR Positive/HER2 Low Expression Metastatic Breast Cancer
Official title Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
ClinicalTrials.gov ID: NCT05904964
What this study is testing
What is Disitamab vedotin?
Disitamab vedotin is an investigational medicine, being studied as a potential treatment for hr positive/her2 low expression metastatic breast cancer.
Also referred to as RC48.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Adult female patients (aged 18-70 years, including 18 and 70 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable...
- Pathological examination confirmed that ER and / or PR were positive, and HER-2 was low expression (ER expression: immunohistochemical staining of...
- Patients who have received endocrine therapy ;
- According to the how well it works evaluation criteria for solid tumors (RECIST) version 1.1, there is at least one evaluable target lesion or only...
- Patients with stable brain metastasis or asymptomatic brain metastasis;
You likely can't join if
- Patients who had received chemotherapy, radiotherapy, immunotherapy, and endocrine therapy for breast cancer within 2 weeks before enrollment.;
- Patients who had performed major surgery within 2 weeks before enrollment.
- Severe heart disease or discomfort within 12 months, including, but not limited to, the following: unstable angina pectoris, myocardial infarction...
- Have active autoimmune diseases (such as corticosteroids or immunosuppressive drugs) requiring systemic treatment in the past 2 years, excluding...
- Have a clear history of neurological or mental disorders, including epilepsy or dementia;
- According to the judgment of the researchers, there are some accompanying diseases that seriously endanger the safety of patients or affect patients...
See the full eligibility criteria
- 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;
- 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...
- Patients who have received endocrine therapy ;
- According to the how well it works evaluation criteria for solid tumors (RECIST) version 1.1, there is at least one evaluable target lesion or only osteolytic bone metastasis;
- Patients with stable brain metastasis or asymptomatic brain metastasis;
- ECOG physical condition score ≤ 2 points, and the estimated survival time is not less than 3 months;
- 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...
- 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;
- 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...
- Patients understand the research process, voluntarily participate in the research, and sign the informed consent form.
- Patients who had received chemotherapy, radiotherapy, immunotherapy, and endocrine therapy for breast cancer within 2 weeks before enrollment.;
- Patients who had performed major surgery within 2 weeks before enrollment.
- 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...
- 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...
- Have a clear history of neurological or mental disorders, including epilepsy or dementia;
- 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.
- Those who have been known to have allergic history to Disitamab Vedotin or similar drugs;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shantou, Guangdong, China
- Qionghai, Hainan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shantou, Guangdong, China; Qionghai, Hainan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.