Phase 2 Breast Cancer 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 aged 18 or older at the time of signing the consent form
• People with a general health status rated as fully active, restricted in strenuous activity but able to do light work, or up and about more than half of waking hours (confirm with trial site for exact rating)
• People whose breast cancer has been confirmed by biopsy or surgical sample to be invasive breast cancer
• People who have had surgery to remove the breast tumour with the aim of curing the cancer, with no visible cancer remaining in the local area, and whose most recent breast or underarm surgery was less than 90 days before signing the consent form (people with very small amounts of cancer cells at the surgical edge may still be eligible if radiation therapy is planned)
• People with no signs that the cancer has spread to distant parts of the body
• People who have not received any systemic (whole-body) treatment for this cancer, other than hormone-blocking therapy given before surgery
• People whose treating cancer doctor recommends chemotherapy after surgery, without combining it with biological or targeted therapies at the same time
• People whose tumour tests positive for hormone receptors (oestrogen receptor greater than 10% and/or progesterone receptor greater than 10%) and tests negative for the HER2 protein, according to standard testing guidelines
• People whose cancer is classified as a specific pathological stage based on tumour size and lymph node involvement (pT1–3 and pN0–2), confirmed by lymph node biopsy or underarm lymph node removal
• People whose tumour is considered high risk based on a gene expression profile test (either "Luminal B" on MammaPrint/BluePrint, or a Recurrence Score above 25 on Oncotype Dx), OR people whose tumour meets certain clinical high-risk features based on age, tumour size, grade, lymph node involvement, or other tumour characteristics (confirm with trial site for exact criteria)
• People whose blood and organ function results (such as kidney and liver tests) fall within acceptable ranges, tested within 30 days before registering for the trial
• People with two separate breast cancers at the same time (in both breasts or multiple tumours in one breast) may be eligible if the treating cancer doctor considers the study treatment appropriate for all tumours requiring chemotherapy
• People who are able to give written consent and authorise the release of their personal health information
• Women who could become pregnant must agree to use two methods of birth control (at least one being a barrier method) if sexually active with a male partner, must not be pregnant or breastfeeding, and must have a negative pregnancy test as required by their treating institution
• People who are able to understand and follow the study procedures for the full duration of the trial, as assessed by the enrolling doctor
• People living with HIV/AIDS who are on anti-retroviral therapy that does not interact with the study drugs, and who have either had no AIDS-defining infections in the past, or have not had such an infection in the last 12 months
• People with chronic or previously resolved Hepatitis B infection who are on appropriate antiviral therapy that does not interact with the study drugs, and whose liver function tests meet the study requirements
• People with a history of Hepatitis C who have completed curative treatment and have an undetectable viral load within 90 days of enrolment (or within 30 days if still on Hepatitis C treatment), and whose antiviral therapy does not interact with the study drugs

Who may not be able to join:

• People who have previously received chemotherapy (cytotoxic treatment) for this breast cancer
• People who have received any experimental treatments within 2 weeks before starting the study chemotherapy
• People whose cancer is classified as stage IIIB, IIIC, or stage IV
• People with an active infection that requires treatment with systemic (whole-body) medication
• People with untreated HIV/AIDS
• People with a confirmed deficiency of the enzyme DYPD, which affects how certain chemotherapy drugs are processed by the body
• People who are pregnant or breastfeeding
• People who need to take warfarin as a blood-thinning medication (other blood thinners such as low molecular weight heparins or direct oral anticoagulants are permitted)
• People with another cancer (past or present) that could interfere with assessing the safety or effectiveness of the study treatment, as determined by the treating cancer doctor
• People with a mental or medical condition that prevents them from giving informed consent or taking part in the trial
• People with other serious health conditions (such as advanced heart or lung disease, or uncontrolled diabetes) that could affect the safety or effectiveness assessment of the study treatment, as determined by the lead study doctor
• People who are unable to swallow pills
• People with a medical condition that affects how oral medications are absorbed by the body
• People who have a medical reason they cannot receive any of the chemotherapy drugs used in the study regimen
• People who are currently taking medications known to interfere with how the study drugs work or are processed by the body
• People who are currently incarcerated
• People who are unable or unwilling to take a large number of oral pills

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