Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: 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 dividing. Giving brostallicin together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer|
- 3-month progression-free survival (PFS) rate [ Designated as safety issue: No ]
- Confirmed response rate (complete or partial response) [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- 6-month PFS rate [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Glutathione/glutathione levels measured at baseline and at 22-26 hours after cisplatin administration (before brostallicin administration) [ Designated as safety issue: No ]
- Correlation of increased glutathione/glutathione levels and primary and secondary endpoints [ Designated as safety issue: No ]
- Correlation of BRCA1 mutation and 3-month PFS [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- To identify any clinical efficacy of treatment with brostallicin and cisplatin, as measured by progression-free survival (PFS) at 3 months, in patients with triple-negative metastatic breast cancer.
- To describe the confirmed tumor response rate in these patients.
- To describe the duration of response in these patients.
- To describe the 6-month PFS of these patients.
- To describe the overall survival of these patients.
- To evaluate the adverse event profile of this regimen according to the current version of NCI CTCAE.
- To assess the baseline glutathione levels in whole blood (before the administration of cisplatin) in these patients and to correlate those levels with the primary and secondary endpoints. (Translational research)
- To evaluate whether cisplatin administered the day before the administration of brostallicin leads to an increased level of glutathione/glutathione S-transferase levels in vivo and whether such increase is associated with improvement of the primary and secondary endpoints. (Translational research)
- To assess the prevalence of BCRA-1 mutation by IHC on the primary or metastatic tumor in these patients. (Translational research)
- To assess the association of BRCA-1 mutation by IHC with the primary and secondary endpoints. (Translational research)
- To bank paraffin-embedded tissue blocks or slides and blood products for future studies as part of ongoing research for NCCTG breast studies. (Translational research)
OUTLINE: This is a multicenter study.
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.
Blood samples are collected periodically for translational research studies. Tumor tissue samples may also be collected for research studies.
After completion of study therapy, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.