Phase 3 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:

• You are a woman aged 18 to 65 years old and are willing to give your consent to take part in the study.
• You have been diagnosed with triple negative metastatic breast cancer (a specific type of breast cancer that has spread) and are planned to receive standard chemotherapy for at least 4 to 6 cycles.
• Your breast cancer diagnosis has been confirmed according to standard medical guidelines.
• You have at least one tumour that is 1 cm or larger in size, visible on a CT or MRI scan.
• You are reasonably able to carry out daily activities, as assessed by a standard medical scale called the ECOG score (rated 0–2) (confirm with trial site).
• Your blood haemoglobin level (a measure of red blood cells) has been stable at 9 g/dL or above during the screening period.
• Your doctor believes you have a life expectancy of at least 6 months.
• You have stable, well-managed conditions such as Type 2 diabetes or high blood pressure, as confirmed by your doctor.
• You are experiencing any level of tiredness or fatigue — whether stable, new, or worsening — as measured by a standard fatigue questionnaire.

Who may not be able to join:

• You have an untreated medical condition that could be causing tiredness, such as an infection, a hormone problem, or an imbalance in your body's chemistry, in your doctor's opinion.
• You are unable to understand the language used in the study questionnaires.
• You are currently taking stimulant medications (such as dextroamphetamine or methylphenidate) or any medication that could interfere with the study drug.
• Your chemotherapy has been delayed, causing the screening period to go beyond 21 days.
• Your cancer has spread to the brain or central nervous system.
• You have a serious, uncontrolled physical or mental health condition that your doctor believes could affect your safety or ability to take part.
• You are pregnant or currently breastfeeding.
• You have a known infection with Hepatitis B, Hepatitis C, or HIV.
• You have severe nausea, vomiting, or a digestive condition that your doctor believes would prevent the study drug from being properly absorbed.
• You have pain that is not well controlled, and your doctor does not consider you suitable for the study.
• You have a known allergy or intolerance to rosmarinic acid, caffeic acid, related plant-based compounds, or any ingredient in the study drug (Nuvastatic® 300 mg) or the placebo (dummy pill).
• You are planning to take part in another clinical trial or receive another experimental treatment.
• You have taken part in another clinical trial or received an experimental treatment within the past 4 weeks before screening, or plan to do so during this study.

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