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Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

2014-08-27 03:15:04 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Tertiary

- 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

brostallicin, cisplatin, laboratory biomarker analysis

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:04-0400

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Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

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A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

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