Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

Pfizer

Status: Terminated

Conditions: Early Breast Cancer

Treatments: Other: Aromasin (exemestane)

Study type: Observational

Funder types: Industry

Identifiers

NCT01155063

A5991092

Details and patient eligibility

About

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 early discontinuation.

Full description

This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.

Enrollment: 89 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal females.
• 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 SPC).
• 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.

Trial design

89 participants in 1 patient group

Main Group

Description:

Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy

Treatment:

Other: Aromasin (exemestane)