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

NCT01047358 | Completed Results

• 1 other identifier: A5991089
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  At the end of the study, average of 5.6 months.

• Time-to-Progression (Early 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)

  At the end of the study, average of 5.6 months

Study Arms (2)

ajuvant group

adjuvant setting after two to three years of tamoxifen

Drug: Aromasin

palliative group

palliative setting after progression of disease with anti-estrogen therapy

Drug: Aromasin

Interventions

Aromasin DRUG

25 mg table QD

Also known as: exemestane

ajuvant group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant breast-feeding premenopausal.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (22)

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, 330-721, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

Myongji Hospital, Kwangdong Unversity College of Medicine

Goyang-si, Gyeonggi-do, 412-270, South Korea

Location

Wonkwang University School of Medicine and Hospital (WUH)

Iksan -si, Jeollabuk-do, 570-749, South Korea

Location

Asan Medical Center

Seoul, Korea, 138-736, South Korea

Location

Seoul National University Hospital (SNUH)

Seoul, Seoul, 110-744, South Korea

Location

Hwasun Hospital, Chonnam National University

Cheonnam, South Jeolla Province, 519-809, South Korea

Location

Inje University Busan Paik Hospital

Busan, 614-735, South Korea

Location

Yeung Nam University Hospital

Daegu, 705-717, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Cheil General Hospital & Women's Healthcare Center

Seoul, 100-380, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135 710, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Asan Medical Center, University of Ulsan

Seoul, 138-736, South Korea

Location

Korea University Medical Center (KUMC) - Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

Ajou University Hospital

Suwon, 443-380, South Korea

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2009
• First Posted: January 12, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 8, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-10

Locations

KR (22)