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Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

2014-08-27 03:55:59 | BioPortfolio

Summary

The purpose of this study is to find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Neoplasms

Intervention

exemestane

Location

Pfizer Investigational Site
Leicester
United Kingdom

Status

Terminated

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:59-0400

Clinical Trials [2592 Associated Clinical Trials listed on BioPortfolio]

Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer....

Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 yea...

The XENERA™-1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Post-menopausal Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

The main objective of the trial is to assess the anti-tumor activity of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in post menopausal patients ...

BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer

Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination w...

PubMed Articles [3601 Associated PubMed Articles listed on BioPortfolio]

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...

Fine-needle Aspiration Cytology to Identify a Rare Mimicker of Breast Cancer: Plasma Cell Mastitis.

There are rare benign diseases that can mimic malignant breast neoplasms in the clinical exam and in mammography. We evaluated the contribution of an accessible procedure to most clinicians, the fine-...

Medical and Biotech [MESH] Definitions

Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.

Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.

Neoplasms, usually carcinoma, located within the center of an organ or within small lobes, and in the case of the breast, intraductally. The emphasis of the name is on the location of the neoplastic tissue rather than on its histological type. Most cancers of this type are located in the breast.

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.

Tumors or cancer of the human BREAST.

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