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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Aromasin

Detailed Description

All cases at the participating institutions.

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 614-735
    • Inje University Busan Paik Hospital
  • Daegu, Korea, Republic of, 705-717
    • Yeung Nam University Hospital
  • Gyeonggi-do, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Incheon, Korea, Republic of, 400-711
    • Inha University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 156-707
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 136-705
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center, University of Ulsan
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
  • Seoul, Korea, Republic of, 158-710
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of, 135 710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital (SNUH)
  • Seoul, Korea, Republic of, 100-380
    • Cheil General Hospital & Women's Healthcare Center
  • Seoul, Korea, Republic of, 152-703
    • Korea University Medical Center (KUMC) - Korea University Guro Hospital
  • Suwon, Korea, Republic of, 443-380
    • Ajou University Hospital
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, Korea, Republic of, 330-721
      • Soon Chun Hyang University Hospital Cheonan
  • Gyeonggi-do
    • Anyang, Gyeonggi-do, Korea, Republic of, 431-070
      • Hallym University Sacred Heart Hospital
    • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
      • Soon Chun Hyang University Bucheon Hospital
    • Goyang, Gyeonggi-do, Korea, Republic of, 412-270
      • Myongji Hospital, Kwangdong Unversity College of Medicine
  • Jeollabuk-do
    • Iksan -si, Jeollabuk-do, Korea, Republic of, 570-749
      • Wonkwang University School of Medicine and Hospital (WUH)
  • Korea
    • Seoul, Korea, Korea, Republic of, 138-736
      • Asan Medical Center
  • South Jeolla Province
    • Cheonnam, South Jeolla Province, Korea, Republic of, 519-809
      • Hwasun Hospital, Chonnam National University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

- Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant breast-feeding premenopausal.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ajuvant group; adjuvant setting after two to three years of tamoxifen	Drug: Aromasin; 25 mg table QD; Other Names: exemestane
palliative group; palliative setting after progression of disease with anti-estrogen therapy	Drug: Aromasin; 25 mg table QD; Other Names: exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.	From the first dose of Aromasin through the end of the study for an average of 5.6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)	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).	At the end of the study, average of 5.6 months.
Time-to-Progression (Early Breast Cancer)	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.	At the end of the study, average of 5.6 months
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)	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.	At the end of the study, average of 5.6 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 24, 2009
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Exemestane
• Other Study ID Numbers: A5991089