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Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

2014-08-27 03:55:01 | BioPortfolio

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.

Description

OBJECTIVES:

- Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy.

- Determine the best overall response rate of patients treated with this drug.

- Determine the progression-free survival of patients treated with this drug.

- Determine the duration of response in patients treated with this drug.

- Determine the safety of this drug in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

gefitinib

Location

Institut Jules Bordet
Brussels
Belgium
1000

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:01-0400

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Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surge...

Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer

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RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. Gefitinib ma...

Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer

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Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib ...

PubMed Articles [14069 Associated PubMed Articles listed on BioPortfolio]

Leptomycin B reduces primary and acquired resistance of gefitinib in lung cancer cells.

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) gefitinib has demonstrated dramatic clinical efficacy in non-small cell lung cancer (NSCLC) patients. However, its therapeutic e...

KLF4 promotes c-Met amplification-mediated gefitinib resistance in NSCLC.

Gefitinib have been widely used in the first-line treatment of advanced EGFR-mutated non-small-cell lung cancer (NSCLC). However, many NSCLC patients will acquire resistance to gefitinib after 9-14 mo...

High cholesterol in lipid rafts reduces the sensitivity to EGFR-TKI therapy in non-small cell lung cancer.

Overcoming EGFR-TKI resistant which has the initial enthusiasm over substantial clinical responses is a formidable challenge on nowadays. In this study, we showed that cholesterol level in lipid rafts...

Breast cancer in octogenarian. Are we doing our best? A population-registry based study.

The number of old people with breast cancer is estimated to increase during the next years in developed countries. However, management of breast cancer in octogenarians is not well established. The ma...

Multiple primary non-breast tumors in breast cancer survivors.

The aim of this study was to assess the frequency of second primary non-breast cancer after breast cancer diagnosis and treatment, and its correlation with clinicopathological features.

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).

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.

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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