Phase 3 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 aged 18 to 75 years old (male or female) who have given written consent to take part in all study procedures.
• People diagnosed with invasive breast cancer that is either HER2-positive (a specific protein level found through lab testing) or HER2-low (a lower level of that same protein), as determined by local lab results using standard guidelines.
• People who have had surgery that fully removed the tumour, with no cancer cells found at the edges of the removed tissue.
• People who are already participating in the SURVIVE study and whose blood tests have detected signs of cancer returning at a molecular level (a positive ctDNA result from that study).
• People with no signs of cancer spread to other parts of the body, confirmed by a CT scan of the abdomen and chest, and a bone scan, performed within 8 weeks before joining the trial.
• People who finished surgery, chemotherapy, and/or radiation therapy at least 6 months before joining the trial.
• People whose heart is pumping at 50% or more of its normal capacity, confirmed by a heart scan within 28 days before joining the trial.
• People who are generally well enough to carry out daily activities with little or no limitation (assessed using a standard medical scale called ECOG, scoring 0 or 1).
• People whose kidneys, liver, and blood counts are functioning at adequate levels, confirmed by blood tests within 28 days before joining the trial.
• People whose hormone receptor status (oestrogen and/or progesterone) has been determined by local lab testing.
• Female participants who are past menopause, or who have a negative pregnancy blood test if they could potentially become pregnant and are sexually active with a male partner who has not had a vasectomy. Eligible female participants of childbearing potential must agree to use at least one highly effective method of contraception from screening until 7 months after the last dose of study treatment, and must not breastfeed during the study or for 7 months after the last dose.
• Female participants must not donate or retrieve eggs from the time of joining the trial until at least 7 months after the final dose of study treatment. Egg preservation may be considered before joining.
• Male participants who are sexually active with a female partner who could potentially become pregnant must use a condom with spermicide from screening until 4 months after the final dose of study treatment, and must not father a child or donate sperm during this period. Sperm preservation may be considered before joining.
• People who have stopped certain previous breast cancer treatments (such as Trastuzumab, Pertuzumab, T-DM1, Capecitabine, Pembrolizumab, and Olaparib) and have waited the required time before starting the study treatment. Hormone therapies such as Tamoxifen or Letrozol may continue alongside the study treatment.
• People whose previous cancer treatment side effects have mostly resolved to a mild or baseline level (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 (stage IV or metastatic breast cancer).
• People who have had another separate cancer, with some exceptions — non-invasive breast cancer (DCIS), other fully treated non-invasive cancers, and adequately treated non-melanoma skin cancers may be acceptable (confirm with trial site).
• People who have previously been treated with T-DXd (trastuzumab deruxtecan), which is the study drug being tested.
• People who have a substance use problem or any significant medical or psychological condition that, in the doctor's opinion, could interfere with taking part in the study.
• People who have had a heart attack within the 6 months before starting the study, or who have moderate to severe heart failure symptoms.
• People whose heart's electrical activity (measured by ECG) shows an abnormally prolonged signal (above specific limits depending on sex).
• People who have a history of lung inflammation (interstitial lung disease or pneumonitis) that needed steroid treatment, who currently have this condition, or where this cannot be ruled out by scan at screening.
• People with an active, uncontrolled infection needing intravenous (IV) antibiotics, antivirals, or antifungal medication.
• People with a known condition that weakens the immune system, uncontrolled active HIV, or active hepatitis B or C infection. People with a past hepatitis C infection may be eligible only if a specific blood test shows no active virus. People with past hepatitis B infection may be eligible only if they meet a number of specific conditions relating to blood test results and liver health (confirm with trial site).
• People with serious ongoing lung conditions, including blood clots in the lungs within the past 3 months, severe asthma, severe chronic lung disease, restricted lung function, or fluid around the lungs.
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) where there is known or suspected lung involvement.
• People who have had a complete removal of one entire lung (pneumonectomy).
• People who have received a live, weakened vaccine within 30 days before starting the study treatment. Participants enrolled in the study should not receive live vaccines during the study or for 30 days after the last dose.
• People who still have unresolved side effects from previous cancer treatments (other than hair loss) that have not returned to a mild or pre-treatment level, with some specific stable exceptions allowed (confirm with trial site).
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People with a history of severe allergic reactions to similar types of medications (monoclonal antibodies).
• Female participants who are pregnant, breastfeeding, or planning to become pregnant.

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