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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01047358
First received: December 24, 2009
Last updated: June 8, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Aromasin
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.


Secondary Outcome Measures:
  • Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer) [ Time Frame: At the end of the study, average of 5.6 months. ] [ Designated as safety issue: No ]
    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).

  • Time-to-Progression (Early Breast Cancer) [ Time Frame: At the end of the study, average of 5.6 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 206
Study Start Date: August 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ajuvant group
adjuvant setting after two to three years of tamoxifen
Drug: Aromasin
25 mg table QD
Other Name: exemestane
palliative group
palliative setting after progression of disease with anti-estrogen therapy
Drug: Aromasin
25 mg table QD
Other Name: exemestane

Detailed Description:

All cases at the participating institutions.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant breast-feeding premenopausal.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047358

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01047358     History of Changes
Other Study ID Numbers: A5991089
Study First Received: December 24, 2009
Results First Received: May 26, 2015
Last Updated: June 8, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 27, 2015