Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
PRIMARY OBJECTIVES: I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast cancer patients having a triple negative (estrogen receptor \[ER\]/progesterone receptor \[PR\]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months. SECONDARY OBJECTIVES: I. To describe the confirmed tumor response rate of patients with measurable disease receiving brostallicin and cisplatin. II. To describe the duration of response in patients with measurable disease receiving brostallicin and cisplatin. III. To describe the 6-month progression-free survival of patients receiving brostallicin and cisplatin. IV. To describe the overall survival (OS) of patients receiving brostallicin and cisplatin. V. To evaluate the adverse event profile of the study regimen (adverse events graded using the Cancer Therapy Evaluation Program \[CTEP\] Active Version of the Common Terminology Criteria for Adverse Events \[CTCAE\]). OUTLINE: Patients receive cisplatin intravenously (IV) over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
