Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China

Pfizer

Status and phase: Completed; Phase 4

Conditions: Breast Neoplasms

Treatments: Drug: Aromasin (exemestane)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176916

A5991093

NRA5990043 (Other Identifier)

Details and patient eligibility

About

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 of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.

Full description

This is interventional study and single arm study. N/A

Enrollment: 564 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.
• ER positive.
• The patient must be postmenopausal woman.
• The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).

Exclusion criteria

• Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.
• Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®).

Trial design

564 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Aromasin (exemestane)