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Tests treatment safety and results for Breast Cancer
Official title Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
ClinicalTrials.gov ID: NCT06642545
What this study is testing
What is Disitamab Vedotin?
Disitamab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntarily agree to participate in the study and sign the informed consent form
- Stage III unresectable locally advanced or Stage IV metastatic breast cancer.
- people must be willing and able to provide a tumor tissue block and/or unstained pathology slides, with priority given to the most recent metastatic...
- Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory
- Invasive tumor tissue is negative for hormone receptors (HR), defined as immunohistochemistry (IHC) testing showing that the proportion of cells with...
You likely can't join if
- Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).
- Having previously received immunotherapy, including anti PD-(L)1 or anti PD-(L)2 drugs, or drugs that directly target another stimulatory or...
- Excluding people with brain metastases or leptomeningeal metastases. people with treated brain metastases (surgery and/or radiotherapy) are eligible...
- Use of investigational drugs or undergoing major surgery within 4 weeks prior to the first dose of study medication
- Received or plan to receive live vaccines or attenuated live vaccines within 4 weeks prior to the first dose of study medication or during the study...
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation
See the full eligibility criteria
Who can join
- Voluntarily agree to participate in the study and sign the informed consent form
- Stage III unresectable locally advanced or Stage IV metastatic breast cancer.
- people must be willing and able to provide a tumor tissue block and/or unstained pathology slides, with priority given to the most recent metastatic lesions that have not previously been subjected to radiotherapy. If...
- Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory
- Invasive tumor tissue is negative for hormone receptors (HR), defined as immunohistochemistry (IHC) testing showing that the proportion of cells with positive nuclear staining for both ER and PgR in invasive cancer is...
- For HR-negative, HER2-low expressing unresectable locally advanced or metastatic breast cancer: locally recurrent and unresectable or previously untreated metastatic breast cancer; or those who have completed curative...
- ECOG performance status of 0 or 1
- According to the RECIST v1.1 criteria, there must be at least one measurable lesion (for lesions that have previously been irradiated, if the lesion can be measured according to the RECIST v1.1 criteria and there is...
- Expected survival of at least 12 weeks
- Hematologic and organ function criteria to be met within 7 days prior to the first dose of study medication (with normal values based on the clinical trial center's standards, and no blood transfusions, hematopoietic...
- Female people of childbearing potential who meet the following conditions: A serum pregnancy test (with a minimum sensitivity of 25 mIU/mL or equivalent units of β-human chorionic gonadotropin [β-hCG]) must be negative...
- Male people of childbearing potential who meet the following conditions: Must agree to abstain from donating sperm from the start of the study until at least 6 months after the last dose of study medication. If having...
- Capable of understanding the trial requirements and willing and able to comply with the trial and follow-up procedures.
What rules you out
- Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).
- Having previously received immunotherapy, including anti PD-(L)1 or anti PD-(L)2 drugs, or drugs that directly target another stimulatory or co-inhibitory T-cell receptor (such as CD137, CTLA-4, OX-40) during the...
- Excluding people with brain metastases or leptomeningeal metastases. people with treated brain metastases (surgery and/or radiotherapy) are eligible for inclusion if they meet the following criteria: people who have...
- Use of investigational drugs or undergoing major surgery within 4 weeks prior to the first dose of study medication
- Received or plan to receive live vaccines or attenuated live vaccines within 4 weeks prior to the first dose of study medication or during the study period
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation
- Uncontrolled or significant cardiovascular or cerebrovascular disease, including (but not limited to): Within 6 months prior to the first dose of study medication, any of the following occurred: congestive heart failure...
- Presence of clinically uncontrollable third space fluid accumulation, such as large amounts of pleural effusion, pericardial effusion, or ascites that are associated with clinical symptoms or require symptomatic...
- History of interstitial lung disease that requires treatment or current severe pulmonary disease, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc.
- A clear history of neurological or psychiatric disorders, either past or present, including epilepsy or dementia, etc.
- Toxicities from previous anti-cancer treatments have not yet recovered to grade 0-1 of the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0), except for alopecia...
- Persistent grade ≥2 sensory or motor neuropathy.
- Active infections that require systemic treatment: Active infections requiring systemic treatment within 7 days prior to the first dose, routine antimicrobial prophylaxis is allowed; Positive HIV test results; Patients...
- Having active autoimmune diseases within the past 2 years that require systemic treatment (such as corticosteroids or immunosuppressive drugs), except for replacement therapies (such as thyroid hormone, insulin, or...
- Having other malignant tumors within 5 years prior to signing the informed consent form (except for effectively treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, stage I...
- Known hypersensitivity or delayed-type allergic reactions to certain components of Disitamab Vedotin, Toripalimab, RC148, or albumin-bound paclitaxone, or similar drugs.
- According to the investigator's judgment, there are serious concomitant diseases that could endanger the subject's safety or affect the subject's ability to complete the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.