Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from the 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 diagnosed with HER2-negative breast cancer that is either locally advanced or has come back and cannot be surgically removed (Stage IIIB–IIIC), or breast cancer that has spread to other parts of the body (Stage IV), and whose cancer appears clinically stable in the opinion of the treating doctor.
• People with hormone receptor-positive breast cancer (ER-positive and/or PR-positive) whose cancer has stopped responding to at least one hormonal therapy or a CDK4/6 inhibitor, or who the treating doctor considers suitable for chemotherapy — any number of prior chemotherapy treatments is allowed for this group.
• People with triple-negative breast cancer (a type that lacks certain receptors), regardless of how many prior treatments have been received.
• People who have not previously been treated with the specific chemotherapy drugs or immune checkpoint inhibitor planned for use in this trial for their advanced or metastatic breast cancer — although people who received those same treatments earlier as part of initial (curative-intent) therapy may still be considered, provided at least 12 months have passed since that earlier treatment ended.
• People who have never previously received a type of treatment called adoptive cell therapy.
• People the treating doctor considers suitable for treatment with nab-paclitaxel or gemcitabine/carboplatin, and a drug called camrelizumab.
• People who have lymph nodes near the tumour that a surgeon can access to grow the specialised cells used in this trial.
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1), including tumours in previously treated areas if they have clearly grown since that treatment.
• People who have recently provided, or are able to provide, a tissue sample (biopsy) from their tumour for laboratory testing, unless this is not safe or possible.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activities).
• People with a life expectancy of at least 4 months.
• People whose blood, liver, kidney, clotting, heart, and lung function all meet the minimum levels required by the trial (confirm with trial site for specific test values).
• Women of childbearing potential who are willing to use effective contraception throughout the study and for at least one year after the last treatment, and who have a negative pregnancy test within 7 days before receiving the cell treatment.
• People who have had a sufficient break from their previous cancer treatments before joining — the required gap depends on the type of treatment previously received (confirm specific timeframes with trial site).
• People who have recovered from side effects of previous cancer treatments to a mild or resolved level, with some specific exceptions allowed (confirm with trial site).

Who may not be able to join:

• People whose cancer is considered by the treating doctor to be rapidly getting worse.
• People with active cancer that has spread to the brain or the lining of the brain, unless it was previously treated and has been shown to be stable on at least two brain scans taken at least 4 weeks apart after treatment.
• People with spinal cord compression that has not been relieved by surgery or radiotherapy, unless symptoms were relieved more than one week before the planned surgery for the trial.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen — although people managing this with a drain in place may still be considered.
• People with cancer pain that is not adequately controlled, or whose pain management plan has not been established before joining.
• People who have had another separate cancer diagnosis within the last 5 years, with some exceptions for certain common skin cancers or non-invasive cancers that have been fully treated (confirm with trial site).
• People with a known history of significant heart problems, including certain types of heart failure, unstable chest pain (angina), a heart attack in the past 3 months, or certain heart rhythm problems requiring treatment.
• People with active or clinically significant lung inflammation (pneumonia or interstitial lung disease), or other serious lung conditions.
• People with an active infection currently requiring treatment with antibiotics or other systemic medications, 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 — such as a stroke, deep vein thrombosis, or pulmonary embolism — within the past 5 months.
• People currently taking part in another clinical trial involving an experimental treatment, or who have done so within the past 4 weeks (those in a follow-up phase of a previous trial may be considered if 4 weeks have passed since their last experimental treatment).
• People with a known psychiatric condition, or alcohol or drug misuse disorder.
• People who are pregnant or breastfeeding.
• People with an active autoimmune disease, a history of autoimmune disease, or autoimmune disease that has required systemic treatment with corticosteroids above a certain dose — though some replacement hormone therapies are permitted.
• People with a known congenital (present from birth) or acquired immune deficiency, including those with HIV.
• People who have had active tuberculosis in the past year, or who had active tuberculosis more than one year ago but did not complete a standard course of treatment.
• People with active hepatitis B or hepatitis C — although people who carry the hepatitis B or C virus with normal viral levels may be considered, provided they receive anti-viral therapy and undergo regular monitoring during the trial.
• 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 with a known allergy or serious reaction to any of the drugs or substances used in this trial, including but not limited to the cell therapy, cyclophosphamide, fludarabine, interleukin-2, certain preservatives and carriers, camrelizumab, nab-paclitaxel, gemcitabine, or carboplatin.
• People who have contraindications to interleukin-2 (a drug used in this trial), such as uncontrolled epilepsy or active gastrointestinal bleeding.
• People with a history of moderate or severe nerve damage (Grade 2 or above neuropathy).
• People currently taking medications that are not permitted in combination with the trial drugs, unless those medications were stopped at least 7 days before joining.
• People with any other condition, treatment history, or test result that the treating doctor believes would make participation unsafe or unsuitable.

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