Skip to main content
OpenTrials
Completed

NCT Number: NCT01047358

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Soon Chun Hyang University Hospital Cheonan, Cheonan, Chungcheongnam-do, South Korea

Loading trial locations.

About this study

All cases at the participating institutions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Postmenopausal women with breast cancer eligible for hormonal therapy.

Exclusion criteria

  • Pregnant breast-feeding premenopausal.

Treatment and study plan

Aromasin

Drug

25 mg table QD

Other names: exemestane

Primary outcomes

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the first dose of Aromasin through the end of the study for an average of 5.6 months

    All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.

Secondary outcomes

  1. Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)

    Time frame: At the end of the study, average of 5.6 months.

    The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF).

  2. Time-to-Progression (Early Breast Cancer)

    Time frame: At the end of the study, average of 5.6 months

    Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.

  3. Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)

    Time frame: At the end of the study, average of 5.6 months

    The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 12, 2010
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.