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 chosen to take part voluntarily and have signed a consent form
• Women aged between 18 and 75 years old
• People with a confirmed diagnosis of advanced triple-negative breast cancer, where the cancer has spread, based on laboratory testing of tissue samples
• People whose cancer has been staged using standard scans (CT0-4/N0-3/M1) (confirm with trial site)
• People whose cancer tests show very low or no HER2 protein activity, confirmed by laboratory testing
• People whose cancer tests show very low or no oestrogen receptor (ER) and progesterone receptor (PgR) activity, confirmed by laboratory testing
• People who have already received at least one prior treatment for their advanced or spreading cancer, including a type of chemotherapy called anthracyclines
• People who have at least one tumour that can be measured on scans, according to standard measurement guidelines
• People whose general health and ability to carry out daily activities falls within an accepted range on a standard medical scale (ECOG score of 0–2)
• People with a life expectancy of at least 12 weeks
• People who have not previously been treated with apatinib or albumin-bound paclitaxel (nab-paclitaxel), unless it was given before or just after surgery as part of earlier treatment
• People whose bone marrow, liver, and kidney function fall within acceptable levels based on blood tests (confirm specific values with trial site)
• Women who are able to become pregnant and agree to use contraception starting one week before the first dose until eight weeks after stopping the study drug

Who may not be able to join:

• Women who are pregnant or currently breastfeeding
• People who have had, or currently have, another cancer — unless it is certain types of skin cancer, early-stage cervical cancer, or another cancer that was fully treated at least five years ago and requires no further treatment
• People with confusion, difficulty cooperating with treatment, a mental illness, or cancer that has spread to the brain or central nervous system
• People who have taken part in another clinical trial in the past three months
• People who have previously been treated with apatinib or similar drugs that target blood vessel growth, or other drugs in the same class as apatinib (small-molecule tyrosine kinase inhibitors)
• People who have received any targeted treatment, surgery, chemotherapy, radiation, or other cancer-directed therapy before enrolling (confirm with trial site, as this may relate to timing)
• People who experienced a rupture or bleeding of veins in the oesophagus or stomach, a bowel blockage, or a hole in the gut within the three months before treatment
• People who have symptoms from fluid build-up caused by cancer around the abdomen or lungs
• People who have an active infection or an unexplained fever of 38.5°C or higher in the seven days before enrolling
• People with serious failure of the liver, kidneys, heart, lungs, brain, or other major organs
• People with high blood pressure that cannot be brought under control with medication (systolic at or above 140 mmHg or diastolic at or above 90 mmHg)
• People with certain lung or breathing conditions, including pulmonary fibrosis, interstitial lung disease, or active pneumonia seen on a scan
• People with abnormal blood clotting results, a tendency to bleed easily, or who are currently on blood-thinning or clot-dissolving medication (with some exceptions — confirm with trial site)
• People with heart problems that are not well controlled, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, significant heart rhythm problems requiring treatment, or an abnormal heart electrical reading (QTc above 470ms)
• People with a significant level of protein in their urine, based on urine testing
• People who cannot swallow tablets or capsules, or who have a condition affecting how the gut absorbs medication
• People who have had a stroke, mini-stroke, blood clot in a deep vein, or a blood clot in the lungs within the six months before enrolling
• People with a personal or family history of inherited or acquired bleeding or clotting disorders, or who have had significant bleeding (such as gastrointestinal bleeding) within three months before enrolling
• People who, in the opinion of the trial team, have other serious medical, social, or personal circumstances that could affect their safety or the reliability of the trial data

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