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 signed a consent form agreeing to take part in the study
• Women aged between 18 and 70 years
• People whose breast cancer has been confirmed through a core needle biopsy (not a surgical biopsy)
• People who have already completed two cycles of a specific chemotherapy combination (doxorubicin or epirubicin, plus cyclophosphamide) and whose cancer was shown to be stable on a breast MRI after those cycles
• People whose breast tumor is at least 1 cm in size as measured by MRI, with any lymph node involvement status, and no spread to distant parts of the body
• People whose breast cancer tests negative for a protein called HER2 (confirmed by specific laboratory tests)
• People whose cancer has been tested for hormone receptor status (estrogen and progesterone receptors) and a growth marker called Ki67
• People who have not had any other breast cancer treatments before joining, apart from the two chemotherapy cycles mentioned above
• People who have lymph nodes near the breast that can be accessed through surgery, and who have not previously had sentinel lymph node biopsy or full underarm lymph node removal for their breast cancer
• People who are generally well enough to carry out light activity and care for themselves (confirmed with trial site)
• People whose blood counts, liver, kidney, heart, lung, and clotting functions all meet the specific levels required by the trial
• Women who are able to become pregnant must be willing to use reliable contraception throughout the trial and for at least one year after the last treatment, and must have a negative pregnancy blood test within 7 days before receiving the study treatment
• People who have recovered from most side effects of their previous chemotherapy to a mild or resolved level before surgery

Who may not be able to join:

• People whose breast cancer has spread to distant parts of the body (metastatic breast cancer)
• People who have had another active cancer in the past 5 years, with exceptions for certain skin cancers, thyroid cancer treated with curative intent, or cervical cancer that has not spread
• People with a known history of serious heart conditions, including significant heart failure, unstable chest pain, a heart attack in the past 3 months, or certain heart rhythm problems requiring treatment
• People with active or significant lung disease, including a type of lung inflammation called interstitial pneumonia
• People with an active infection that requires treatment through the bloodstream, or an unexplained fever above 38.5°C not caused by the cancer
• People who have had a blood clot in an artery or vein (such as a stroke, deep vein clot, or lung clot) in the past 5 months
• People with a known psychiatric condition, or alcohol or substance use disorder
• People who are pregnant or breastfeeding
• People with an active autoimmune disease, a history of autoimmune disease, or who have needed immune-suppressing medications (such as higher-dose steroids) for an autoimmune condition — hormone replacement therapies for certain conditions are generally allowed (confirm with trial site)
• People with a known history of congenital or acquired immune deficiency, including HIV
• People who have had tuberculosis in the past year, or a history of tuberculosis more than one year ago that was not properly treated
• People with known active hepatitis B or hepatitis C where the virus is detectable — those who carry the virus but have normal virus levels may still be considered (confirm with trial site)
• People who have received a live vaccine within 4 weeks before joining, or who plan to receive one during the trial
• People who have previously had a bone marrow or organ transplant from another person
• People who have previously received certain study-related medications (such as taxane, fludarabine, or interleukin-2), apart from the two allowed chemotherapy cycles
• People with a known allergy or serious reaction to any of the drugs or ingredients used in this trial, including the study treatment (LNL), chemotherapy agents, albumin, or certain antibiotics
• People with certain conditions that make one of the study drugs (interleukin-2) unsafe to use, such as uncontrolled epilepsy or active gastrointestinal bleeding
• People with a history of moderate or severe nerve damage (Grade 2 or higher neuropathy)
• People who have recently received certain medications that affect blood vessel growth (such as bevacizumab) within four weeks before joining
• People currently taking medications that are not allowed to be used alongside the study treatments
• People with any other condition, treatment history, or test result that the trial doctor believes would make participation unsafe or interfere with the study results

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