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:

• Women between the ages of 18 and 70
• People diagnosed with invasive breast cancer in one breast, confirmed by a tissue sample (biopsy), regardless of the specific type
• People whose cancer was considered operable at the time of diagnosis, with no absolute medical reasons preventing surgery
• People whose surgery removed all visible and microscopic cancer, with no tumor left behind
• People who are able to begin chemotherapy after surgery within eight weeks of the operation
• People whose breast cancer is hormone receptor-positive and HER2-negative (HR+/HER2−), with cancer found in four or more lymph nodes under the arm
• People whose hormone receptor status (ER and PgR) was confirmed through laboratory testing of tumor tissue
• People who had no signs of cancer spread to other parts of the body on scans or examinations before surgery
• People with no nerve damage or numbness in the hands or feet (peripheral neuropathy)
• People with a general health score of 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity), known as the ECOG scale
• People who have recovered well from surgery, with at least one week having passed since the operation
• People whose blood counts and organ function (liver, kidneys, blood cells, and related measures) fall within acceptable ranges on tests done within 28 days before starting the study treatment — specific thresholds apply for each measure (confirm with trial site)
• People on anticoagulant (blood-thinning) medication who have been on a stable dose for at least 28 days before starting the study
• Women of childbearing potential who agree to use highly effective contraception (with a failure rate of less than 1% per year) or remain abstinent during treatment and for at least 6 months after the last dose of certain chemotherapy drugs, or 12 months after others, whichever comes last
• People with a heart pumping function (left ventricular ejection fraction) above 50%, confirmed by an ultrasound scan of the heart
• People who have read and signed the informed consent form agreeing to participate in the trial

Who may not be able to join:

• People with a previous history of invasive cancer of any kind
• People whose breast tumor was classified as a T4 stage tumor (a more advanced local stage), including those with inflammatory breast cancer
• People who have already received systemic cancer treatment for their current breast cancer diagnosis before joining the trial — this includes chemotherapy, anti-HER2 therapies, hormone therapy, or radiation therapy
• People who have previously been treated with anthracycline or taxane chemotherapy drugs for any cancer
• People who have a history of a certain type of non-invasive breast cancer (DCIS or LCIS) in the same breast and received systemic therapy, hormone therapy, or radiation for it before developing invasive cancer — though people treated with surgery and/or radiation only for DCIS or LCIS in the opposite breast may still be considered eligible (confirm with trial site)
• People with significant heart or lung problems before joining the trial, including certain types of heart failure, uncontrolled irregular heartbeat, severe heart valve disease, recent heart attack, very high blood pressure that cannot be controlled, or a need for oxygen therapy (confirm with trial site for full details)
• People who have had another cancer in the past 5 years, except for certain low-risk cancers that are expected to be cured with treatment, such as certain skin cancers or carcinoma in situ (confirm with trial site)
• People with a known allergy or sensitivity to any of the chemotherapy drugs used in this trial (docetaxel, carboplatin, cyclophosphamide, or epirubicin), or to certain white blood cell–stimulating medications used alongside treatment
• People who had a serious infection requiring hospital admission in the four weeks before starting the study, or who received antibiotic treatment in the two weeks before starting — though people on preventive (prophylactic) antibiotics may still be considered eligible (confirm with trial site)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with poorly controlled high blood pressure (systolic above 150 mmHg and/or diastolic above 100 mmHg)
• People with a mental illness, cognitive impairment, or any condition that would make it difficult to understand the trial requirements or complete all visits and follow-up
• People who do not have personal freedom or the legal capacity to make independent decisions

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