Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)

Exclusion Criteria

• •Has had prior radiation therapy to \> 20% of the whole skeleton.
• •Has had \> 5 prior chemotherapy treatment regimens for metastatic breast cancer.
• •Has a history of autoimmune or hereditary hemolysis or gastrointestinal bleeding.
• •Has clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic or genitourinary disease unrelated to underlying hematologic disorder.
• •Has heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher.
• •Has a recent history of thrombosis, deep vein thrombosis (DVT), pulmonary emboli, or embolic stroke, occurring within the last 6 months.
• •Has untreated central nervous system (CNS) metastases or CNS metastases treated with whole brain radiotherapy \< 6 months prior to Day 1.
• •Has a diagnosis of a myeloid malignancy or known history of myelodysplasia.
• •Has a history of second malignancy within 5 years (except excised and cured basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ).
• •Has had administration of IV antibiotics or febrile (temperature elevation \> 38 ° C) within 14 days of Day 1.
• •Has uncontrolled hypertension.
• •Has known history of hepatitis B surface antigen (HBsAg and HB core antibody (Ab)), human immunodeficiency virus (HIV) antibody or active hepatitis C.
• •Has clinically significant iron (transferrin saturation \< 20%), vitamin B12, or folate deficiency.
• •Has a history of anemia as a result of inherited hemoglobinopathy such as sickle cell anemia or thalassemia.
• •Has a history of autoimmune or hereditary hemolysis; active gastrointestinal bleeding (within the last 6 months as compared to Day 1).
• •Has received treatment with another investigational drug or device within 1 month prior to Day 1.
• •Is pregnant or lactating.
• •Has a history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product.
• •Has had major surgery within 30 days prior to Day 1 (patients must have completely recovered from any previous surgery prior to Day 1).