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 been diagnosed with hormone receptor-positive advanced breast cancer (confirmed through a lab test of tumor tissue), where the cancer has come back, spread to other parts of the body, or cannot be removed with surgery
• People whose breast cancer tumor has a specific low level of a protein called HER2 (measured as IHC 2+/ISH- or IHC 1+), confirmed using approved testing guidelines
• People who have no previous history of having HER2-positive breast cancer (a higher level of HER2 than described above)
• People whose cancer got worse while receiving a first-line treatment combining a hormone therapy and a CDK4/6 inhibitor (such as palbociclib, ribociclib, or abemaciclib, combined with an aromatase inhibitor or fulvestrant), and who have not received any other systemic treatment for advanced breast cancer
• People who previously received chemotherapy or hormone therapy before or after surgery for early breast cancer may still be eligible
• Female patients aged 19 years or older
• People who have clear evidence from scans or tests that their cancer has continued to grow or spread since their last treatment
• People who have at least one area of cancer that can be measured on a scan (that was not previously treated with radiation, or that has clearly grown after radiation)
• People who can provide a tumor tissue sample for testing at a central laboratory
• People with a general health status rated as ECOG 0 or 1, meaning they are either fully active or have some limits on heavy physical activity but can do light work (confirm with trial site)
• Both pre-menopausal and post-menopausal women may be eligible; pre-menopausal women receiving certain hormone therapies as part of the trial will need to also receive treatment to suppress ovarian function (either by injection or surgery)
• People whose blood and organ function results fall within acceptable ranges based on tests done within 14 days before joining, including: sufficient haemoglobin (red blood cell levels), albumin (a blood protein), blood clotting measures, white blood cell counts, platelet counts, kidney function, liver enzyme levels, and bilirubin levels — specific thresholds apply (confirm with trial site)
• People with a normal or near-normal heart tracing on an ECG, with a specific heart rhythm measure (QTc) at or below 470 milliseconds, and no history of a particular dangerous heart rhythm called Torsades de pointes
• People whose heart pumping function (LVEF) is at least 50%, confirmed by a heart scan within 28 days before joining
• People with no history of lung inflammation (pneumonitis), except that caused by radiation
• People who are able and willing to give written informed consent to participate
• People who are not pregnant or breastfeeding
• Women who could become pregnant must use effective contraception starting two weeks before treatment begins, throughout treatment, and for seven months after the last dose
• People who have completed required waiting periods after previous treatments before enrolling — these waiting times vary depending on the type of prior treatment and range from 2 weeks to 6 weeks (confirm with trial site for specifics)

Who may not be able to join:

• People who have previously been treated with T-DXd or Dato-DXd for advanced breast cancer
• People with serious heart conditions, such as uncontrolled high blood pressure, heart failure, irregular heartbeat, active heart disease, or a heart attack within the past year
• People who have had a heart attack in the 6 months before joining, or who have moderate-to-severe heart failure symptoms; people with elevated troponin (a heart-related blood marker) at screening will need to see a heart specialist before being considered
• People with active liver or bile duct disease (some exceptions apply, such as a condition called Gilbert syndrome, certain stable liver conditions, or liver spread from the breast cancer)
• People with an active, uncontrolled infection currently requiring intravenous antibiotics, antivirals, or antifungal medications
• People who have received a live or weakened virus vaccine within 30 days before the first dose of study treatment (note: mRNA vaccines and certain other types are not considered live vaccines)
• People who still have unresolved side effects from previous cancer treatments that are worse than mild (Grade 1), with some exceptions for certain stable, long-standing side effects such as nerve damage, fatigue, or some hormone-related conditions from prior immunotherapy (confirm with trial site)
• People with significant ongoing lung conditions such as recent blood clots in the lungs, severe asthma, severe chronic obstructive pulmonary disease (COPD), restricted lung function, large fluid collections around the lungs, certain autoimmune diseases affecting the lungs, or who have had a lung removed
• People who have a history of non-infectious lung inflammation (ILD/pneumonitis), currently have this condition, or where this condition cannot be ruled out on a scan
• People with cancer that has spread to the brain and is causing symptoms, requires treatment such as radiation or surgery, or is not yet stable; people with previously treated and stable brain metastases may be considered if they meet specific conditions (confirm with trial site)
• People whose mental state, psychological situation, family circumstances, or location would make it very difficult to follow the trial requirements
• People with active immune deficiency conditions, HIV infection, or active hepatitis B or C infection; some people with past resolved hepatitis B or C infections may still be considered depending on specific test results (confirm with trial site)
• People who have had more than one type of cancer in the past 5 years, with some exceptions such as certain skin cancers, cancers that were fully treated and cured, or cancer in the other breast
• People who are unable to swallow oral medication, or who have gut conditions that would prevent medication from being properly absorbed
• People who are pregnant or breastfeeding
• People who have previously received an allogeneic bone marrow transplant (a transplant using donor bone marrow)
• People with a known allergy or severe reaction to T-DXd or similar antibody-based medicines
• People who have previously been treated with a type of drug called an antibody-drug conjugate that contains a topoisomerase I inhibitor from the exatecan family (confirm with trial site)

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