A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
Summary
The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.
Description
This is a prospective, non-comparative, non interventional study (NIS) in six hundred (600) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a
Study Design
Time Perspective: Prospective
Conditions
Invasive Early Breast Cancer
Intervention
Aromasin
Status
Enrolling by invitation
Source
Pfizer
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01121549
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:05:46-0400
Clinical Trials
Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China
Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years o...
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India. - Efficacy of the treatment with Aromasin® - ...
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
Quality of life under therapy with Aromasin® according to IBCSG (International Breast Cancer Study Group) questionnaire. Change of the endometrium after switching from tamoxifen to Aroma...
Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for...
PubMed Articles
Histological subtype, (invasive ductal breast cancer (IDBC)/invasive lobular breast cancer (ILBC)), might be a marker for differential response to endocrine therapy in breast cancer.
Despite the high incidence of breast cancer worldwide, methods for early non-invasive diagnosis and sensitive and specific prognostic evaluation remain difficult. In this study, we investigated microw...
Immune Infiltration in Invasive Lobular Breast Cancer.
Invasive lobular breast cancer (ILC) is the second most common histological subtype of breast cancer after invasive ductal cancer (IDC). Here, we aimed at evaluating the prevalence, levels, and compos...
An increasing number of women is surviving breast cancer and due to that at risk of developing an isolated ipsilateral breast tumor recurrence (IBTR) or a contralateral breast cancer (CBC). Patients' ...
Breast Osteoblast-like Cells: A Reliable Early Marker for Bone Metastases From Breast Cancer.
The development of bone metastasis from breast cancer results from a functional interaction between tumor cells and osteoclasts or osteoblasts. The main aim of this study was therefore to test the hyp...
Medical and Biotech [MESH] Definitions
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)
Breast Cancer Lymphedema
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
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.
Early Detection Of Cancer
Methods to identify and characterize cancer in the early stages of disease and predict tumor behavior.
Capecitabine
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
