A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

Pfizer

Status: Terminated

Conditions: Invasive Early Breast Cancer

Treatments: Drug: Aromasin

Study type: Observational

Funder types: Industry

Identifiers

NCT01121549

A5991091

Details and patient eligibility

About

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.

Full description

This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) 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 The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.

Enrollment: 378 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal females, defined as one from the next :

  1. Natural menopause >/=1 year,
  2. Surgical ovariectomy,
  3. Chemotherapy-induced amenorrhoea >/=2 years.

• Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.

• Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.

• Patients whose tumour was estrogen receptor positive (ER+).

• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

• Patients for whom Aromasin® treatment is contraindicated (see SmPC).
• Presence of metastasis or a contra lateral tumour.
• Other adjuvant endocrine therapy.
• Another concomitant antineoplastic treatment
• Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
• The patients are not supposed to participate to any other trial during all the study period.

Trial design

378 participants in 1 patient group

Aromasin

Description:

All patients included in the study

Treatment:

Drug: Aromasin