Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)
Condition: Breast Neoplasm; Brain Neoplasm; Second Neoplasm
MeSH terms: Neoplasms; Breast Neoplasms; Brain Neoplasms; Neoplasms, Second Primary; Recurrence
Intervention: temozolomide
Intervention description: Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether temozolomide can be used as a prophylaxis
      against brain recurrence in participants with metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic breast cancer.

          -  Participants must have completed first line of metastatic chemotherapy and have
             achieved complete or partial response or disease stability for at least 6 months from
             the first confirmation of disease stabilization.

          -  No clinical sign of brain progression.

          -  At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or
             estrogen receptor (ER)-/progesterone receptor (PgR)-

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

          -  Life expectancy ≥3 months.

          -  Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1
             x 10^9/L.

          -  Bilirubin level either normal or <1.5 x ULN (upper limit of normal).

          -  AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x
             ULN if liver metastases are present).

          -  Serum creatine <1.5 x ULN.

          -  Effective contraception if the risk of conception exists.

        Exclusion Criteria:

          -  Concurrent chronic systemic immune therapy not indicated in the study protocol.

          -  Any investigational agent(s) within 4 weeks prior to entry.

          -  Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or
             participant in active chemotherapy treatment.

          -  Clinically relevant coronary artery disease or a history of a myocardial infarction
             within the last 12 months.

          -  Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.

          -  Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.

          -  Known drug abuse/alcohol abuse.

          -  Legal incapacity or limited legal capacity.

          -  Medical or psychological condition which in the opinion of the investigator would not
             permit the participant to complete the study or sign meaningful informed consent.

          -  Women who are pregnant or breastfeeding.

          -  Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of
             the cervix (participants with a previous malignancy but without evidence of disease
             for ≥5 years will be allowed to enter the trial).