Trial Outcomes & Findings for Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer (NCT NCT01239745)

NCT ID: NCT01239745

Last Updated: 2012-10-31

Results Overview

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

• Recruitment status: TERMINATED
• Target enrollment: 46 participants
• Primary outcome timeframe: Baseline up to Month 36
• Results posted on: 2012-10-31

Participant Flow

Participant milestones

Measure	Exemestane Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Overall Study STARTED	46
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Measure	Exemestane Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Overall Study Study terminated by sponsor	45
Overall Study Adverse Event	1

Baseline Characteristics

Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

Baseline characteristics by cohort

Measure	Exemestane n=46 Participants Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Age Continuous	59.0 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Type of Tumor Invasive ductal carcinoma	31 participants n=5 Participants
Type of Tumor Invasive lobular carcinoma	7 participants n=5 Participants
Type of Tumor Papillary carcinoma	0 participants n=5 Participants
Type of Tumor Medullary carcinoma	1 participants n=5 Participants
Type of Tumor Mucinous (colloid) carcinoma	2 participants n=5 Participants
Type of Tumor Other	5 participants n=5 Participants
Type of Surgery	NA participants n=5 Participants
Hormone Receptor Status	46 participants n=5 Participants
Lymph Node Status	NA participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Stage I	18 participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Stage IIA	14 participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Stage IIB	5 participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Stage IIIB	4 participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Stage IV	0 participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Stage IIIA	4 participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Stage IIIC	0 participants n=5 Participants
Tumor Node Metastasis (TNM) Stage Other	1 participants n=5 Participants
Histopathological Grade Grade 1	10 participants n=5 Participants
Histopathological Grade Grade 2	19 participants n=5 Participants
Histopathological Grade Grade 3	7 participants n=5 Participants
Histopathological Grade Unknown	10 participants n=5 Participants
Number of participants on chemotherapy	NA participants n=5 Participants
Number of participants on radiotherapy	NA participants n=5 Participants
Concomitant morbidities in the past Cholelithiasis	1 participants n=5 Participants
Concomitant morbidities in the past Intracranial aneurysm	1 participants n=5 Participants
Concomitant morbidities in the past Cystitis noninfective	1 participants n=5 Participants
Concomitant morbidities in the past Reproductive tract disorder	3 participants n=5 Participants
Concomitant morbidities in the past Hypertension	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Month 36

Population: Safety analysis set included participants who received at least one dose of the study medication during the observation period.

Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Outcome measures

Measure	Exemestane n=46 Participants Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Number of Participants With Adverse Events (AEs)	2 participants

SECONDARY outcome

Timeframe: Baseline up to Month 36

Population: Safety analysis set included participants who received at least one dose of the study medication during the observation period.

Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.

Outcome measures

Measure	Exemestane n=46 Participants Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Number of Participants With Concomitant Morbidities Coronary artery disease	1 participants
Number of Participants With Concomitant Morbidities Glaucoma	1 participants
Number of Participants With Concomitant Morbidities Scotoma	1 participants
Number of Participants With Concomitant Morbidities Crohn's disease	1 participants
Number of Participants With Concomitant Morbidities Fatigue	1 participants
Number of Participants With Concomitant Morbidities Multiple allergies	1 participants
Number of Participants With Concomitant Morbidities Skin infection	1 participants
Number of Participants With Concomitant Morbidities Diabetes mellitus	1 participants
Number of Participants With Concomitant Morbidities Arthralgia	2 participants
Number of Participants With Concomitant Morbidities Collagen disorder	1 participants
Number of Participants With Concomitant Morbidities Intervertebral disc protrusion	1 participants
Number of Participants With Concomitant Morbidities Osteoporosis	3 participants
Number of Participants With Concomitant Morbidities Headache	1 participants
Number of Participants With Concomitant Morbidities Depression	1 participants
Number of Participants With Concomitant Morbidities Hypertension	8 participants

SECONDARY outcome

Timeframe: Baseline up to Month 36

Population: Safety analysis set included participants who received at least one dose of the study medication during the observation period.

Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.

Outcome measures

Measure	Exemestane n=46 Participants Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Number of Participants With Concomitant Medications	0 participants

SECONDARY outcome

Timeframe: Baseline up to Month 36

Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Month 36

Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Month 36

Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Month 36

Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline until death (up to Month 36)

Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Outcome measures

Outcome data not reported

Adverse Events

Exemestane

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Exemestane n=46 participants at risk Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.2% 1/46 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hot flush	2.2% 1/46 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject 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 Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER