Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)
Condition: Chemotherapy Induced Anemia
MeSH terms: Anemia
Intervention: Sotatercept; Placebo
Intervention description: up to 4 subcutaneous doses of sotatercept given once every 28 days; up to 4 subcutaneous doses of placebo given once every 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; metastatic; breast; cancer

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).