Comparing Lasofoxifene in combination with with Fulvestrant in combination with for metastatic breast cancer

Exclusion

• −Subjects with a known hypersensitivity to fulvestrant or to any of the excipients
• −Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• −Lymphangitic carcinomatosis involving the lung.
• −History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.
• −Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.
• −Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0 (Day 1). Subjects must have recovered from radiotherapy toxicities prior to Visit 0 (Day 1).
• −Known RB1 mutations or deletions that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → confer resistance to CDK4/6i. (ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → for RB1 mutation is not required for entry.)
• −History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of \>480 msec.
• −History of a pulmonary embolus (PE), deep vein thrombosis (DVT), or any known thrombophilia, unless the event occurred greater than 6 months prior to screening and the subject is treated with chronic anticoagulant therapy such as apixaban (Eliquis) or rivaroxaban (Xarelto).
• −Lasofoxifene is not recommended for use in subjects with conditions that place them at increased risk for VTEs (such as severe congestive heart failure \[CHF\] or prolonged immobilization).
• −On concomitant strong CYP3A4 inhibitors.
• −On strong and moderate CYP3A4 inducers.
• −Any significant co-morbidity that would impact the study or the subject's safety, including subjects with significant malabsorption.
• −Active systemic bacterial or fungal infection (requiring intravenous \[IV\] antibiotics or antifungals at the time of initiating study treatment).
• −Women who are breast feeding
• −History of non-compliance to medical regimens.
• −Unwilling or unable to comply with the protocolProtocolThe detailed plan a study must follow.Read more →.
• −Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
• −Subjects with a history of familial hypertriglyceridemia or fasting triglyceride levels \>880 mg/dL at screening.
• −Fasting triglyceride level \>300 mg/dL and ≤880 mg/dL at screening. Subjects may be retested and enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → if they have a repeat fasting triglyceride level less than or equal to 300 mg/dL prior to enrollment (e.g., after adjustment with diet and/or treatment).
• −Fasting cholesterol level \>400 mg/dL at screening. Subjects may be retested and enrolled if they have a repeat fasting cholesterol level less than or equal to 400 mg/dL prior to enrollment (e.g., after adjustment with diet and/or treatment).
• −Positive serum pregnancy test (only if premenopausal).
• −Sexually active premenopausal women and men unwilling to use double-barrier contraception.
• −Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
• −History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery.