Trial Outcomes & Findings for Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer (NCT NCT01047358)

NCT ID: NCT01047358

Last Updated: 2015-10-08

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 206 participants
• Primary outcome timeframe: From the first dose of Aromasin through the end of the study for an average of 5.6 months
• Results posted on: 2015-10-08

Participant Flow

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

Participant milestones

Measure	Aromasin 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 Study STARTED	206
Overall Study COMPLETED	206
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Aromasin n=206 Participants 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.
Age, Continuous	57.2 Years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	206 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Treatment Indication Adjuvant Therapy for Early Breast Cancer	81 Participants n=5 Participants
Treatment Indication Second-Line Therapy for Advanced Cancer	125 Participants n=5 Participants

PRIMARY outcome

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

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

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

Outcome measures

Measure

Aromasin n=206 Participants 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.

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

25.24 Percentage of Participants

SECONDARY outcome

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

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

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).

Outcome measures

Measure

Aromasin n=74 Participants 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.

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

95.95 Percentage of Participants

SECONDARY outcome

Timeframe: At the end of the study, average of 5.6 months

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of the study, average of 5.6 months

Population: Efficacy Analysis Set.

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.

Outcome measures

Measure	Aromasin n=112 Participants 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.
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) CR	0.89 Percentage of Participants
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) PR	4.46 Percentage of Participants
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) PD	45.54 Percentage of Participants
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) SD	49.11 Percentage of Participants

Adverse Events

Aromasin

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aromasin n=206 participants at risk 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.
General disorders CONDITION AGGRAVATED	0.49% 1/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
General disorders ASTHENIA	0.49% 1/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM	0.49% 1/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.

Other adverse events

Measure	Aromasin n=206 participants at risk 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.
General disorders LEG PAIN	1.9% 4/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
General disorders OEDEMA PERIPHERAL	1.5% 3/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Nervous system disorders HEADACHE	2.4% 5/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Hepatobiliary disorders BILIRUBINAEMIA	1.5% 3/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Hepatobiliary disorders SERUM GLUTAMIC OXALOACETIC TRANSAMINASE INCREASED	2.4% 5/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Hepatobiliary disorders SERUM GLUTAMIC PYRUVIC TRANSAMINASE INCREASED	1.9% 4/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Metabolism and nutrition disorders PHOSPHATASE ALKALINE INCREASED	2.4% 5/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Musculoskeletal and connective tissue disorders ARTHRALGIA	3.4% 7/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Musculoskeletal and connective tissue disorders BACK PAIN	2.4% 5/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	2.4% 5/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Musculoskeletal and connective tissue disorders SKELETAL PAIN	1.5% 3/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Psychiatric disorders ANOREXIA	1.5% 3/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Psychiatric disorders DEPRESSION	1.5% 3/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Psychiatric disorders INSOMNIA	2.4% 5/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Respiratory, thoracic and mediastinal disorders COUGHING	3.9% 8/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.4% 5/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Respiratory, thoracic and mediastinal disorders PHARYNGITIS	1.5% 3/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.
Blood and lymphatic system disorders LYMPHOEDEMA	1.5% 3/206 • From first dose of Aromasin through the end of the study for an average of 5.6 months. 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60