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Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer

2014-08-27 03:57:09 | BioPortfolio

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane plus goserelin may fight breast cancer by reducing the production of estrogen.

PURPOSE: Phase II trial to study the effectiveness of exemestane and goserelin in treating premenopausal women who have metastatic breast cancer that has not responded to previous tamoxifen.

Description

OBJECTIVES: I. Determine the efficacy of exemestane and goserelin in premenopausal women with hormone receptor positive metastatic breast cancer after tamoxifen failure. II. Determine the toxicity of this regimen in these patients. III. Determine the hormonal profile of patients treated with this regimen. IV. Determine the predictive value of HER-2, epidermal growth factor receptor, and estrogen receptor for response in patients treated with this regimen.

OUTLINE: Patients receive oral exemestane daily on days 1-28 and goserelin subcutaneously on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

exemestane, goserelin

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York
New York
United States
10016

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:09-0400

Clinical Trials [4537 Associated Clinical Trials listed on BioPortfolio]

RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. RO4929097 may s...

Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if...

Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer

To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone

Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight breast cancer by blocking the uptake of estrogen. It is not yet...

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients ...

PubMed Articles [14132 Associated PubMed Articles listed on BioPortfolio]

Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study).

We investigated the efficacy and safety of fulvestrant plus goserelin (F + G) versus anastrozole plus goserelin (A + G) in comparison with goserelin (G) alone in premenopausal women with hormone r...

A New Genetic Risk Score to Predict the Outcome of Locally Advanced or Metastatic Breast Cancer Patients Treated With First-Line Exemestane: Results From a Prospective Study.

Approximately 50% of locally advanced or metastatic breast cancer (MBC) patients treated with first-line exemestane do not show objective response and currently there are no reliable biomarkers to pre...

A real-life study on the implementation and effectiveness of exemestane plus everolimus per hospital type in patients with advanced breast cancer. A study of the Southeast Netherlands Advanced Breast Cancer registry.

We aimed to assess the implementation and effectiveness of exemestane plus everolimus treatment per hospital type in real-life, shortly after approval of everolimus.

Everolimus-based combination therapies for HR+, HER2- metastatic breast cancer.

Metastatic breast cancer (MBC) is the leading cause of cancer-related morbidity and mortality among women worldwide. Endocrine therapy is the standard of care for the most common subtype of MBC, hormo...

Efficacy and safety of the combination of metformin, everolimus and exemestane in overweight and obese postmenopausal patients with metastatic, hormone receptor-positive, HER2-negative breast cancer: a phase II study.

Background Increased adiposity is thought to result in worse clinical outcomes in patients with breast cancer through increased estrogen production, hyperinsulinemia, insulin resistance, and activatio...

Medical and Biotech [MESH] Definitions

A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.

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.

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