study of sotatercept for the treatment of chemotherapy induced anemia in patients with metastatic breast cancer (mk-7962-012)

Conditions: Chemotherapy Induced Anemia

Summary: the purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (cia) in participants with metastatic breast cancer. hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dl relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (rbc) transfusion or treatment with an erythropoiesis-stimulating agent (esa).


Eligibility criteria:
inclusion criteria: * has a histologically confirmed diagnosis of breast cancer documented by cytology or biopsy. * has evidence of metastatic breast cancer with a minimum of one lesion per response evaluation criteria in solid tumors v 1.1 (recist v 1.1) criteria. * is receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine, vinorelbine or capecitabine. * has planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after day 1 of study intervention administration. * ≥ 30 days elapsed (from day 1) since previous treatment with an erythropoiesis stimulating agent (esa) (including treatment with intravenous (iv) iron) for chemotherapy induced anemia. * ≥ 7 days elapsed (from day 1) since the last red blood cell (rbc) transfusion and receipt of ≤ 2 units of blood in the past 30 days. * life expectancy of ≥ 6 months. 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).

Keywords: anemia metastatic breast cancer