Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer

Inclusion criteria

• Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.
• Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.
• Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.
• Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.
• The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
• Life expectancy ≥ 6 months, as per the investigator's judgment.
• Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM) and hypertension who are deemed stable by the investigator can be included in the study.
• At screening, patients with stable fatigue, newly developed fatigue, or worsening fatigue scores as assessed by the Brief Fatigue Inventory (BFI) should be included.

Exclusion criteria

• Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the investigator's clinical judgment.
• Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.
• Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.
• Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
• Patients with known central nervous system (CNS) involvement.
• Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator, may affect the patient's safety or study participation and conduct.
• Female patients who are pregnant or breastfeeding.
• Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
• Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.
• Patients with uncontrolled pain, who in the opinion of the investigator are not eligible for the study.
• Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.
• Patients with planned therapy or treatment with another investigational agent.
• Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an investigational agent, other than as specified by this protocol, during the study period.