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 have signed a consent form agreeing to take part in the study.
• Women aged between 18 and 70 years old.
• People who have had a core needle biopsy (a specific type of tissue sample taken with a needle) that has confirmed invasive breast cancer — surgical biopsy results are not accepted.
• People who have already received exactly two cycles of a specific chemotherapy combination (doxorubicin or epirubicin, plus cyclophosphamide) and whose breast cancer showed stable disease on a breast MRI scan after those cycles.
• People whose breast cancer tumor measures at least 1 cm at its widest point on MRI, with any lymph node involvement status, and no spread to distant parts of the body.
• People whose breast cancer tests negative for HER2 (a specific protein), based on standard laboratory testing methods.
• People whose breast cancer has been tested for hormone receptors (estrogen and progesterone) and a cell-growth marker called Ki67, and where possible, whose tumor grade is known.
• People who have not received any other breast cancer treatment before, apart from the two chemotherapy cycles described above — this includes no radiation, hormone therapy, targeted therapy, biological therapy, or surgery for breast cancer.
• People who have accessible lymph nodes near the affected breast that can be reached by surgery, and who have not previously had sentinel lymph node biopsy or underarm lymph node removal for this cancer.
• People who are generally well enough to carry out light activity and care for themselves, based on a standard medical fitness scale (ECOG score of 0 or 1).
• People whose blood, liver, kidney, clotting, heart, and lung function all meet specific minimum levels as measured by standard tests (confirm exact thresholds with trial site).
• Women who could become pregnant must be willing to use reliable contraception throughout the study and for at least one year after the last treatment dose, and must have a negative pregnancy blood test within 7 days before receiving the study treatment.
• People who have recovered from side effects of their prior chemotherapy to a mild or resolved level before the surgical procedure to collect lymph nodes — with some specific exceptions allowed (confirm with trial site).

Who may not be able to join:

• People whose breast cancer has spread to other parts of the body (metastatic breast cancer).
• People who have been diagnosed with another cancer in the last 5 years — though some exceptions apply, such as certain skin cancers that have been treated, early-stage cervical cancer, or a specific type of non-invasive breast condition that has been treated with full surgical removal (confirm with trial site).
• 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 irregular heart rhythms that require treatment.
• People with active or clinically significant lung inflammation (interstitial pneumonia or active pneumonia), or other conditions that seriously affect breathing.
• People with an active infection requiring treatment with antibiotics or other systemic medicines, or who have an unexplained fever above 38.5°C not caused by cancer.
• People who have had a blood clot in an artery or vein in the past 5 months, such as a stroke, deep vein clot, or clot in the lungs.
• People with a known psychiatric condition, or problems with alcohol or substance use.
• People who are pregnant or currently breastfeeding.
• People with an active autoimmune disease, a history of autoimmune disease, or a condition that required ongoing immune-suppressing treatment above a certain dose — though certain replacement hormone therapies are allowed (confirm with trial site).
• People with a known history of a condition that weakens the immune system from birth, or an acquired immune deficiency such as HIV.
• People who have had active tuberculosis in the past year, or had tuberculosis more than a year ago that was not properly treated.
• People with active hepatitis B or hepatitis C — though people who are carriers with normal virus levels in their blood may be eligible, provided they receive antiviral treatment and regular monitoring during the trial (confirm with trial site).
• People who have received a live vaccine within 4 weeks before joining the trial, or who plan to receive one during the trial.
• People who have had a bone marrow or organ transplant from another person.
• People who have previously received certain specific medications related to this study (such as taxane, fludarabine, or interleukin-2), apart from the two allowed chemotherapy cycles.
• People who have a known allergy or serious reaction to any of the drugs or ingredients used in this study, including but not limited to the study cell therapy, chemotherapy agents, albumin, or certain antibiotics.
• People who have a known reason they cannot receive interleukin-2 (one of the study treatments), 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 received certain long-acting drugs that affect blood vessel growth (such as bevacizumab) within four weeks before joining the trial.
• People currently taking any medication that is prohibited in combination with the study treatments, unless that medication was stopped at least 7 days before joining.
• People whose overall health, other conditions, or test results may interfere with the study or make participation not in their best interest, as determined by the treating doctor.

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