Phase 1 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 have been diagnosed with HER2-negative breast cancer.
• People whose tumor is hormone receptor (HR) negative or only very weakly hormone receptor positive.
• People whose breast cancer has been assessed as a certain size and spread — specifically, tumors classified as T1c with lymph node involvement (N1–N2), or tumors classified as T2–T4 with lymph nodes ranging from not involved to moderately involved (N0–N2) (confirm with trial site).
• People whose treating doctor has determined they are medically and surgically suitable to receive chemotherapy before surgery (neoadjuvant chemotherapy) followed by standard local treatment.
• People aged 18 years or older.
• People who are in good general health, able to carry out normal daily activities, or who have minor limitations due to illness (ECOG performance status 0 or 1 — confirm with trial site).
• People whose blood, liver, and kidney function results fall within acceptable ranges, as tested within 14 days before enrolling.
• People whose heart pumping function (left ventricular ejection fraction) is within the normal range as measured by a heart scan.
• Women who could become pregnant must agree to use two forms of contraception during the study and for 5 months after the last dose, and must have a negative pregnancy test before joining. Women who are post-menopausal (no periods for at least 12 months naturally) or who have been surgically sterilised are also eligible.
• People who are willing and able to understand and sign a written informed consent form before enrolling.

Who may not be able to join:

• People who have previously received anthracycline-based chemotherapy for any cancer.
• People who have inflammatory breast cancer.
• People who are currently receiving another experimental treatment or any other active cancer treatment.
• People with uncontrolled or serious ongoing illness, such as an active infection, heart failure, unstable chest pain, irregular heart rhythm, or a psychiatric or social situation that would make it difficult to follow the study requirements.
• People with an active autoimmune disease, or a history of autoimmune disease that could come back and affect vital organs or require immune-suppressing treatment — including long-term use of steroid medications for one month or more.
• Women who are pregnant or currently breastfeeding.
• People with a history of another cancer, unless it was a fully treated skin cancer (basal-cell or squamous-cell), cervical cancer in situ, or any other cancer from which the person has been cancer-free for at least 3 years.
• People who have tested positive for HIV or been diagnosed with AIDS.
• People who have tested positive for Hepatitis B or Hepatitis C, indicating an active or ongoing infection.
• People who have received a live vaccine within 30 days before enrolling.
• People who are unable to follow the treatment schedule and study procedures for any reason.
• People who have received a breast cancer vaccine treatment within the past 3 months.
• People who have previously received any form of HER2- or HER3-primed DC1 therapy (confirm with trial site).

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