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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01047358
• Collaborator: (none)
• Enrollment: 206
• Locations: 22
• Duration (Months): 48
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Aromasin; Drug: Aromasin

Detailed Description

All cases at the participating institutions.

Study Design

• Study Type: Observational
• Actual Enrollment: 206 participants
• 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
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant breast-feeding premenopausal.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01047358
• Other Study ID Numbers: A5991089
• First Posted: Jan 12, 2010
• Last Update Posted: Oct 8, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Breast Neoplasms; Exemestane

Study Results

Participant Flow

Recruitment Details	Participants were enrolled between June 2010 and June 2014 from 25 Korean health care centers.

Arm/Group Title	Aromasin
Arm/Group Description	Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
Period Title: Overall Study
STARTED	206
COMPLETED	206
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Aromasin
Arm/Group Description	Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
Overall Participants	206
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.2 (9.9)
Sex: Female, Male (Count of Participants)
Female	206 100%
Male	0 0%
Treatment Indication (Number) [Number]
Adjuvant Therapy for Early Breast Cancer	81 39.3%
Second-Line Therapy for Advanced Cancer	125 60.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once.

Arm/Group Title	Aromasin
Arm/Group Description	Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
Measure Participants	206
Number [Percentage of Participants]	25.24 12.3%

2. Secondary Outcome

Title	Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)
Description	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 Frame	At the end of the study, average of 5.6 months.

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available.

Arm/Group Title	Aromasin
Arm/Group Description	Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
Measure Participants	74
Number [Percentage of Participants]	95.95 46.6%

3. Secondary Outcome

Title	Time-to-Progression (Early Breast Cancer)
Description	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.
Time Frame	At the end of the study, average of 5.6 months

Outcome Measure Data

Analysis Population Description

This outcome was planned to be analyzed in participants with early breast cancer in the efficacy analysis set. However, the analysis was not performed because the data of time-to-progression was not captured in the CRF.

Arm/Group Title	Aromasin
Arm/Group Description	Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
Measure Participants	0

4. Secondary Outcome

Title	Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)
Description	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.
Time Frame	At the end of the study, average of 5.6 months

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set.

Arm/Group Title	Aromasin
Arm/Group Description	Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
Measure Participants	112
CR	0.89 0.4%
PR	4.46 2.2%
SD	49.11 23.8%
PD	45.54 22.1%

Adverse Events

Time Frame	From first dose of Aromasin through the end of the study for an average of 5.6 months.
Adverse Event Reporting Description	The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Aromasin
Arm/Group Description	Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
All Cause Mortality
	Aromasin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Aromasin
	Affected / at Risk (%)	# Events
Total	2/206 (1%)
General disorders
CONDITION AGGRAVATED	1/206 (0.5%)
ASTHENIA	1/206 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM	1/206 (0.5%)
Other (Not Including Serious) Adverse Events
	Aromasin
	Affected / at Risk (%)	# Events
Total	40/206 (19.4%)
Blood and lymphatic system disorders
LYMPHOEDEMA	3/206 (1.5%)
General disorders
LEG PAIN	4/206 (1.9%)
OEDEMA PERIPHERAL	3/206 (1.5%)
Hepatobiliary disorders
BILIRUBINAEMIA	3/206 (1.5%)
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE INCREASED	5/206 (2.4%)
SERUM GLUTAMIC PYRUVIC TRANSAMINASE INCREASED	4/206 (1.9%)
Metabolism and nutrition disorders
PHOSPHATASE ALKALINE INCREASED	5/206 (2.4%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	7/206 (3.4%)
BACK PAIN	5/206 (2.4%)
MUSCULOSKELETAL PAIN	5/206 (2.4%)
SKELETAL PAIN	3/206 (1.5%)
Nervous system disorders
HEADACHE	5/206 (2.4%)
Psychiatric disorders
ANOREXIA	3/206 (1.5%)
DEPRESSION	3/206 (1.5%)
INSOMNIA	5/206 (2.4%)
Respiratory, thoracic and mediastinal disorders
COUGHING	8/206 (3.9%)
DYSPNOEA	5/206 (2.4%)
PHARYNGITIS	3/206 (1.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.