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 aged 18 or older, of any menopausal status, who have been diagnosed with HER2-positive, Stage I breast cancer that has been confirmed by a tissue biopsy.
• People whose cancer has not spread to nearby lymph nodes, or has only spread in a very small amount (called micrometastases), as determined by specific surgical and laboratory testing of the lymph nodes.
• People whose HER2-positive status has been confirmed through central laboratory testing by a facility called NeoGenomics (testing must be completed before treatment begins).
• People who have had all visible tumour removed through either a full mastectomy or a lumpectomy, with clear margins (no cancer cells at the edges of the removed tissue).
• People whose surgery took place no more than 90 days before the planned start of treatment.
• People who have cancer in both breasts, provided each tumour individually meets all the eligibility requirements.
• People who have multiple tumour sites in the same breast, provided each tumour individually meets all the eligibility requirements.
• People with a history of a non-invasive breast condition called DCIS on the same side, provided it was treated with surgery alone (no radiation), or treated with a mastectomy for the current breast cancer.
• People who have had up to 4 weeks of tamoxifen or other hormone therapy for this cancer before joining (hormonal treatment cannot continue during the first 12 weeks of the trial).
• People who have had a short course of partial breast radiation (lasting 14 days or fewer) before joining, as long as it was completed at least 2 weeks before starting trial treatment.
• People who took part in a short pre-surgery study involving an investigational treatment (2 weeks or less), as long as that treatment was stopped at least 14 days before joining this trial.
• People whose bone marrow, blood counts, and liver function results fall within the acceptable ranges specified by the trial (confirm specific values with the trial site).
• People whose heart is pumping at 50% efficiency or above, as measured by a specific heart scan.
• People who are not pregnant, confirmed by a blood or urine test (required for those who could become pregnant, including those who have had a tubal ligation or are within 12 months of their last menstrual period).
• People who are willing and able to use an effective non-hormonal form of contraception throughout treatment and for 7 months after the last dose (hormonal contraception is not permitted).
• People who are willing and able to give informed consent to participate.
• People who have tumour tissue available to send to a research facility (if tissue is unavailable, the trial doctor must document the reason).
• People who can read and understand English may also participate in quality-of-life surveys; those who cannot are still eligible for the trial itself but would not take part in those surveys.
• People who previously had an oophorectomy (removal of ovaries) for cancer prevention.

Who may not be able to join:

• People who are currently pregnant or breastfeeding.
• People who are unwilling or unable to use adequate non-hormonal contraception during and after treatment (applies to both women of childbearing potential and men with partners who could become pregnant).
• People whose tumour was locally advanced at diagnosis — for example, tumours attached to the chest wall, or with skin changes such as swelling, ulceration, or inflammatory-looking skin.
• People with a history of a previous invasive breast cancer.
• People who have received chemotherapy within the past 5 years.
• People who have previously been treated with a chemotherapy drug called paclitaxel.
• People with active liver disease, such as from hepatitis B, hepatitis C, an autoimmune liver condition, or a bile duct disease called sclerosing cholangitis.
• People with a history of another cancer, unless they have been free of that cancer for at least 5 years and the trial doctor considers the risk of it returning to be low. (Exceptions apply for cervical cancer in situ and non-melanoma skin cancers, which do not affect eligibility regardless of when they were treated.)
• People with serious ongoing health conditions, including active unresolved infections, kidney failure requiring dialysis, active heart disease, a previous heart attack with ongoing symptoms, a history of heart failure or current treatment for heart failure, uncontrolled high blood pressure, significant mental health conditions, or other conditions that the trial doctor believes would make it difficult to safely participate.
• People with a history of DCIS on the opposite breast.
• People who have previously had whole-breast radiation therapy.

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