Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing to take part voluntarily and sign a consent form
• People diagnosed with stage III breast cancer that cannot be surgically removed, or stage IV breast cancer that has spread to other parts of the body
• People who are able to provide a sample of tumor tissue (either a stored tissue block or fresh tissue slides) for testing — most recent tissue from a spread of the cancer is preferred
• People whose breast cancer has been confirmed by a central laboratory to have low levels of a protein called HER2
• People whose breast cancer tests negative for hormone receptors (meaning less than 1% of cancer cells respond to estrogen or progesterone); people with very low hormone receptor activity (1–10%) may also be considered in some cases, after review by the investigator and approval from the study sponsor (confirm with trial site)
• People whose cancer has come back locally and cannot be removed by surgery, or whose cancer has spread and has not yet been treated with systemic therapy for the advanced stage; or people who finished curative treatment at least 6 months before their cancer came back — and if taxane chemotherapy was part of earlier treatment, at least 12 months must have passed since the last taxane dose
• People with a general health rating of 0 or 1 on the ECOG scale, meaning they are fully active or have only mild limitations in physical activity
• People who have at least one area of cancer that can be measured using standard imaging criteria (RECIST v1.1)
• People expected to live for at least 12 weeks
• People whose blood and organ function test results, taken within 7 days before the first dose, meet the following minimum levels (without recent blood transfusions or growth factor support in the prior 14 days):
  • Hemoglobin at least 90 g/L
  • Neutrophil count at least 1.5 × 10⁹/L
  • Platelet count at least 100 × 10⁹/L
  • Liver function and clotting test results within acceptable ranges
  • Kidney function showing adequate clearance
  • Urine protein within acceptable limits
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose, and must agree to use contraception during the study and for at least 6 months after the last dose, and must not breastfeed or donate eggs during that time
• Men who could father a child must agree not to donate sperm and to use contraception during the study and for at least 6 months after the last dose; those with a pregnant or breastfeeding partner must use condoms throughout
• People who are able to understand and follow the trial requirements and attend follow-up visits

Who may not be able to join:

• People who have previously received any anti-HER2 treatment, including antibody-drug conjugates (ADCs)
• People who have previously received immunotherapy drugs (such as PD-1 or PD-L1 inhibitors) during the locally advanced or metastatic stage of their illness — except those who received such treatment as part of earlier (pre-surgery or post-surgery) therapy, provided the last dose was at least 12 months before the cancer came back
• People with active brain metastases or cancer that has spread to the lining of the brain; people with previously treated brain metastases may be considered if their brain disease has been stable for at least 4 weeks and they have been off steroids and anti-seizure medications for at least 14 days (confirm with trial site)
• People who have taken an investigational (experimental) drug or had major surgery within the 4 weeks before the first dose
• People who have received, or plan to receive, live or weakened live vaccines within 4 weeks before the first dose or during the study
• People who have had a bone marrow or organ transplant from a donor
• People with serious uncontrolled heart or blood vessel problems, including any of the following in the past 6 months: severe heart failure, heart attack, stroke, blood clot in the lungs, unstable chest pain, or arrhythmias needing treatment; or ongoing conditions such as certain types of cardiomyopathy, significantly abnormal heart rhythm readings, atrial fibrillation of a certain severity, or uncontrolled high blood pressure
• People with large, clinically significant fluid build-up in body cavities (such as around the lungs, heart, or abdomen) that is causing symptoms or requiring treatment
• People with a history of lung disease affecting the tissue of the lungs (interstitial lung disease) that has required treatment, or who currently have serious lung conditions such as active tuberculosis
• People with a significant history of neurological or psychiatric conditions, such as epilepsy or dementia
• People who still have side effects from previous cancer treatments that have not recovered to a mild or resolved level (grade 0–1), with some exceptions such as hair loss or skin colour changes
• People with ongoing moderate or severe nerve problems affecting sensation or movement (grade 2 or higher neuropathy)
• People with active infections requiring systemic (whole-body) treatment within 7 days before the first dose; people who test positive for HIV; or people with active hepatitis B or C with detectable virus levels in the blood
• People who have had an active autoimmune disease requiring systemic treatment (such as steroids or immune-suppressing drugs) within the past 2 years — some replacement therapies (such as thyroid hormone or insulin) are exceptions
• People who have had another cancer in the past 5 years, with some exceptions such as certain treated skin cancers, cervical carcinoma in situ, localised prostate cancer, early-stage endometrial cancer, or other cancers considered fully cured
• People with a known serious allergic reaction to the study drugs (Disitamab Vedotin, Toripalimab, RC148, or albumin-bound paclitaxel) or similar medicines
• People with other serious health conditions that, in the investigator's judgment, could put them at risk or prevent them from completing the study

Important: Always verify eligibility with the trial site directly before applying.