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:

• Adults who have been diagnosed with breast cancer that has been confirmed by a tissue sample (biopsy), is HER2 negative, hormone receptor positive (HR+), and cannot be surgically removed or has spread to other parts of the body
• People whose cancer has been shown by scans to have grown or spread and cannot be surgically removed
• People who have received certain chemotherapy treatments (anthracyclines and taxanes) before surgery or after surgery, and have had exactly one chemotherapy treatment for advanced breast cancer — and whose cancer has continued to grow during or after treatment with a CDK 4/6 inhibitor combined with hormone therapy. Previous treatment with certain other targeted therapies (PI3K inhibitors, mTOR inhibitors, AKT inhibitors, and PARP inhibitors) is also allowed
• People who have a tumour area that a doctor can easily reach with a biopsy needle (bone metastases are an exception to this requirement)
• People who have at least one tumour that can be measured on a scan, at a different location from the biopsy site
• People who are considered fairly well and able to care for themselves, based on a standard medical performance scale (ECOG score of 0 or 1)
• People who are expected to live for at least 12 weeks
• People whose blood test results show their bone marrow and organs are functioning well enough, based on tests done within 14 days before starting the trial
• Women who could become pregnant must have a negative pregnancy test before joining (blood test within 14 days or urine test within 72 hours of enrolment), and must agree to use a highly effective form of contraception during the study and for at least 7 months after the last dose of the study drug. Acceptable methods include hormonal or non-hormonal intrauterine devices (IUDs), a progestogen-only implant under the skin, both fallopian tubes blocked, a vasectomised partner, or complete avoidance of heterosexual intercourse. Women must also not donate or retrieve their own eggs from screening until at least 7 months after their final dose
• Male participants who can produce sperm must agree to use a condom during intercourse with a female partner who could become pregnant, along with an additional contraceptive method used by the partner, and must not donate or freeze sperm from screening until at least 4 months after the final dose. If a male participant has no sperm due to vasectomy or a medical condition (confirmed by medical records), contraception is not required
• People who are able to understand, agree to, and sign the consent form before any study procedures begin, and who are willing and able to attend study visits and follow study procedures
• People who are covered by a social security or health insurance system

Who may not be able to join:

• People whose breast cancer could potentially be removed by surgery or treated with radiation therapy to cure it
• People who have ever had a lung condition called interstitial lung disease (ILD), currently have it, or are suspected of having it
• People with serious lung problems caused by ongoing lung conditions, autoimmune or inflammatory diseases affecting the lungs, or who have had a lung surgically removed
• People taking high-dose steroid tablets (more than the equivalent of 10 mg of prednisone daily) or other immune-suppressing medicines regularly before starting the trial. People using inhalers, inhaled steroids, or local steroid injections may still be eligible
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord (leptomeningeal disease)
• People who have a disease or condition affecting the cornea (the clear front surface of the eye)
• People with serious uncontrolled health conditions, including active bleeding problems, active infections, certain psychiatric conditions, substance use concerns, or other conditions the trial doctor considers would make participation unsafe or difficult
• People with untreated and symptomatic cancer spread to the brain or spinal cord, or brain metastases that require steroid or anti-seizure medication to manage symptoms
• People who have received any cancer treatment (including experimental treatments) within 4 weeks or 5 half-lives (whichever is shorter) before joining the trial
• People who have not waited long enough after certain previous treatments before starting the trial, including:
  • Whole-brain radiation less than 14 days ago, or targeted brain radiation less than 7 days ago
  • Immune checkpoint therapy less than 21 days ago
  • Hormone therapy less than 21 days ago
  • Major surgery (not including insertion of a port or line) less than 28 days ago
  • Radiation to a large area of bone marrow or a wide field less than 28 days ago, or palliative radiation less than 14 days ago
  • Chloroquine or hydroxychloroquine within the last 14 days
  • A live virus vaccine within the last 28 days
• People who have previously been treated with an anti-HER3 antibody or a specific type of antibody-drug combination (ADC) containing a topoisomerase I inhibitor called an exatecan derivative
• People who still have significant side effects (grade 2 or higher) from previous cancer treatments, except for hair loss
• People who have had a severe allergic reaction to the study drug (U3-1402) or similar medicines, or to any of their ingredients
• People who have had another type of cancer within the three years before starting the trial, with some exceptions such as certain skin cancers or cancers that were completely cured
• People with significant heart problems before starting the trial, including:
  • An abnormal heart rhythm measurement on an ECG (above 470 ms for women or 450 ms for men, using a specific calculation method)
  • Reduced heart pumping function (less than 50% on a heart scan)
  • High resting blood pressure (above 140/90 mmHg)
  • A heart attack within the past 6 months
  • Symptomatic heart failure within the past 28 days
  • Uncontrolled chest pain (angina) within the past 6 months
  • A heart rhythm problem requiring medication
• People with active or uncontrolled Hepatitis B infection — though people with certain stable, well-managed Hepatitis B may still be eligible (confirm with trial site)
• People with active or uncontrolled Hepatitis C infection — though people with a past Hepatitis C infection that is no longer detectable and not currently being treated may still be eligible (confirm with trial site)
• People with active or uncontrolled HIV infection — though people with HIV who have well-controlled levels, a healthy immune cell count, no recent serious HIV-related illnesses, and who have been on a stable HIV treatment regimen for at least 4 weeks may still be eligible (confirm with trial site)
• People with any other significant medical history, current illness, surgical history, physical finding, or abnormal test result that the trial doctor believes could affect safety or interfere with how the drug works or how results are assessed
• People with an active, uncontrolled bacterial, fungal, or viral infection throughout the body. People with a localised fungal infection of the skin or nails may still be eligible
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with psychological, family, social, or geographic circumstances that might make it difficult to follow the study schedule and procedures
• People who are under legal guardianship, have had their freedom restricted by a legal or administrative decision, or are not able to give their own consent
• People who are currently taking part in another clinical trial testing an experimental drug (non-interventional research studies may be acceptable — confirm with trial site)

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