Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.
Triple-negative Breast Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer|
- PFS rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Confirmed response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- PFS rate [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
- Survival time [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cisplatin and brostallicin)
Patients receive cisplatin 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.
Given IVDrug: cisplatin
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.
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]).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091454
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|Study Chair:||Alvaro Moreno Aspitia, MD||Mayo Clinic|