Gemcitabine in Treating Elderly Women With Metastatic Breast Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating elderly women who have metastatic breast cancer.
Description
OBJECTIVES: I. Determine the safety and efficacy of gemcitabine in the treatment of elderly women with metastatic breast cancer. II. Evaluate the quality of life in these patients.
OUTLINE: Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8 week course. Treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 12 weeks. Patients are followed every 3 months for 2 years, then every 6 months until year 5, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.
Study Design
Primary Purpose: Treatment
Conditions
Breast Cancer
Intervention
gemcitabine hydrochloride
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00005614
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
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)
Mucin-1
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.
Breast Neoplasms
Tumors or cancer of the human BREAST.
Brca1 Protein
The phosphoprotein encoded by the BRCA1 gene (GENE, BRCA1). In normal cells the BRCA1 protein is localized in the nucleus, whereas in the majority of breast cancer cell lines and in malignant pleural effusions from breast cancer patients, it is localized mainly in the cytoplasm. (Science 1995;270(5237):713,789-91)
Clinical Trials
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping...
Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not ye...
RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells...
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
To evaluate the overall response rate of gemcitabine and vinorelbine combination (GV) and gemcitabine followed by vinorelbine (G⇒V) when used as palliative therapy in patients with stage...
PubMed Articles
BACKGROUND: The primary objective of this multicenter, open-label, randomized, parallel, phase II selection trial was to compare the objective tumor response to biweekly (every 2Â weeks) gemcitabine/p...
BACKGROUND: Recently gemcitabine has been approved for treatment of metastatic or recurrent breast cancer in Japan; however, no systematically investigated safety study of long-term gemcitabine monoth...
BACKGROUND: Neoadjuvant chemotherapy (NACT) is being increasingly used for patients with large-size operable breast cancer. This phase 2 study of sequential NACT with gemcitabine and doxorubicin (GemÂ...
The basal-like subtype of breast cancer is characterized by a "triple negative" (TN) phenotype (ER-, PR-, HER2/neu-). TN breast cancers share similar gene expression profiles and DNA repair deficienci...
Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer.
Evaluation of: Valle J, Wasan H, Palmer DH et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N. Engl. J. Med. 362, 1273-1281 (2010). Biliary tract cancer is a rare disease...
