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

• Overall Safety profile characterized by type, frequency and severity of adverse events as graded according to the NCI/CTEP CTCAE, v4.0 and their relationship with study therapy. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
• Overall Safety profile characterized by type, frequency and severity of adverse events as graded according to the NCI/CTEP CTCAE, v4.0 and their relationship with study therapy. [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

• Number of Participants With Concomitant Morbidities [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
  Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
• Number of Participants With Concomitant Medications [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
  Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.
• Percentage of Participants Who Discontinued the Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
• Number of Participants With Reasons for Discontinuation From Study Treatment [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
• Time to Discontinuation of Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
• Percentage of Participants With Recurrent Disease [ Time Frame: Month 36 or early withdrawal ] [ Designated as safety issue: No ]
  Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).

• The profile of patients treated with Aromasin® characterized by age, type of tumor, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy and concomitant morbidity and treatment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• The profile of patients treated with Aromasin® characterized by age, type of tumor, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy and concomitant morbidity and treatment. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
• The rate of treatment discontinuation. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• The rate of treatment discontinuation. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
• The reasons and the timing for discontinuation of Aromasin® therapy. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• The reasons and the timing for discontinuation of Aromasin® therapy. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
• Recurrence-free survival from the initiation of Aromasin® treatment to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary ipsilateral or contralateral breast cancer, death due to any cause. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Recurrence-free survival from the initiation of Aromasin® treatment to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary ipsilateral or contralateral breast cancer, death due to any cause. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
• Overall survival calculated as the time from the initiation of Aromasin® treatment to the date of death due to any cause. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Overall survival calculated as the time from the initiation of Aromasin® treatment to the date of death due to any cause. [ Time Frame: 30 months ] [ Designated as safety issue: No ]

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.

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.

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

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.