Phase 2 Cardiomyopathy Trial, Recruiting

Written by an AI model from the 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 a specific type of breast cancer called triple-negative breast cancer (TNBC), or a hormone receptor-low invasive breast cancer, at Stage II or Stage IIIA/B (meaning the cancer is locally advanced but has not spread to distant parts of the body).
• The cancer must have very low or no hormone receptor activity (estrogen and/or progesterone receptors present in 10% or fewer of cancer cells), confirmed through lab testing.
• The cancer must be HER2-negative, confirmed according to standard testing guidelines.
• The tumour in the breast must be larger than 1 cm, as seen on imaging, with or without involvement of underarm lymph nodes.
• People with more than one tumour in the breast may still be considered, as long as the main tumour meets the hormone receptor and HER2 criteria above.
• Adults aged 18 or older, of any gender.
• People who are considered well enough to carry out daily activities, with only mild limitations at most (as measured by a standard medical scale called ECOG, scoring 0 to 2).
• People who are medically suitable to undergo breast surgery with the goal of curing the cancer.
• People who have not yet received any chemotherapy, immunotherapy, radiation, or surgery for their current breast cancer diagnosis (diagnostic biopsies are permitted).
• People who are able to be monitored by a heart doctor or general doctor if needed to manage any existing heart-related conditions.
• People whose blood counts, kidney function, liver function, and blood clotting levels meet the minimum thresholds required by the trial (confirmed through blood tests at the time of screening).
• People who have had breast and underarm imaging (including ultrasound and MRI) within six weeks before joining the trial.
• People with abnormal-looking lymph nodes under the arm who have had those nodes confirmed as cancerous through a biopsy or fine needle aspiration.
• People who have had scans to check for cancer spread to other parts of the body, where required based on imaging results or symptoms.
• People with cancer in both breasts may be considered, provided both tumours are HER2-negative and all other criteria are met.
• People with mild or no pre-existing nerve damage (nerve problems rated grade 2 or lower on a standard medical scale).
• People of childbearing potential who are willing and able to use a highly effective, non-hormonal form of contraception from the time of consent, throughout treatment, and for at least six months after the last dose of trial treatment.
• People who are willing and able to attend all required study visits, follow the treatment plan, and complete all study-related requirements.
• People who are willing to sign a written consent form before any study-related procedures begin.
• People living with HIV who are on effective anti-retroviral treatment and have had an undetectable viral load on a test taken within the past six months.
• People with a history of chronic hepatitis B who have an undetectable hepatitis B viral load while on appropriate treatment, based on the most recent test within the past six months (testing only required if directed by local health authorities).
• People with a history of hepatitis C who have completed treatment and been cured, or who are currently being treated and have an undetectable hepatitis C viral load on a test within the past six months (testing only required if directed by local health authorities).
• People who are not suitable for anthracycline-based chemotherapy (a common type of chemotherapy used in breast cancer) for at least one of the following reasons:
  • They have a pre-existing heart muscle condition with reduced heart pumping function (ejection fraction between 25–49%), severe heart valve disease, previous exposure to anthracycline chemotherapy, previous high-dose chest radiation (over 30 Gy), or a recent heart attack, unstable chest pain, blood clot in an artery, or stroke occurring between 3 and 12 months ago.
  • They are assessed as being at medium or high risk of developing heart failure within three years, based on a specific medical prediction tool.
  • They have chosen not to receive anthracycline treatment after a thorough discussion with their doctor about its role in treating their cancer.
  • They have been assessed by their oncologist and the study's principal investigator as medically unsuitable for anthracyclines for another medical reason not listed above.

Who may not be able to join:

• People who are currently participating in, or have recently participated in, another clinical trial involving an experimental treatment or device within the four weeks before starting this trial.
• People who have been diagnosed with breast cancer that has spread to other parts of the body (metastatic breast cancer) or a type called inflammatory breast cancer.
• People who are considered medically unfit to undergo curative breast surgery.
• People who have had, or currently have, another type of cancer within the past five years — although people with certain skin cancers (basal cell or squamous cell carcinoma of the skin) or certain non-invasive cancers (such as DCIS or cervical carcinoma in situ) that have been treated with curative intent are not excluded on this basis.
• People who have had a known severe allergic reaction to medications similar to carboplatin or paclitaxel (the chemotherapy drugs used in this trial).
• People who have had major surgery recently and have not yet sufficiently recovered from its effects or complications.
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or typhoid vaccines) within 30 days before starting treatment — note that most standard flu and COVID injections are generally permitted, but nasal spray flu vaccines are not.
• People who have a condition that weakens the immune system, or who are taking high-dose steroid medications (equivalent to more than 10 mg of prednisone daily) or other medications that suppress the immune system on an ongoing basis.
• People who have an active autoimmune disease (a condition where the immune system attacks the body) that has required systemic medical treatment within the past year.
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People who have a history of non-infectious lung inflammation that required high-dose steroid treatment, or who currently have lung inflammation.
• People who have an active bacterial infection requiring treatment with antibiotics or other systemic medicines.
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in the trial's requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period or within 180 days after the last dose of trial treatment.
• People of childbearing potential who have a positive pregnancy test within 24 hours before starting treatment.
• People with uncontrolled high blood pressure (systolic reading above 180 mmHg or diastolic reading above 100 mmHg) or uncontrolled or symptomatic irregular heartbeat at the time of the screening visit.
• People whose heart pumping function (ejection fraction) is below 25% at the time of the screening visit.

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