Trial Outcomes & Findings for An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin (NCT NCT00776659)
NCT ID: NCT00776659
Last Updated: 2013-11-19
Results Overview
Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
TERMINATED
39 participants
Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)
2013-11-19
Participant Flow
Participant milestones
| Measure |
Exemestane
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Exemestane
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
Baseline Characteristics
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Baseline characteristics by cohort
| Measure |
Exemestane
n=39 Participants
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Age Continuous
|
60.0 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)Population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
Outcome measures
| Measure |
Exemestane
n=7 Participants
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Locoregional/Distant Recurrence
|
0 participants
|
|
Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Missing/No response
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)Population: FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Exemestane
n=7 Participants
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
Second primary or contralateral breast cancer
|
0 participants
|
|
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
Missing/No response
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline until death (up to Year 3.5)Population: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.
Outcome measures
| Measure |
Exemestane
n=39 Participants
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Number of Participants Who Died
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline until discontinuation (up to Year 3.5)Population: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.
Outcome measures
| Measure |
Exemestane
n=39 Participants
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Number of Participants Who Discontinued Aromasin Therapy
|
26 participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of study treatmentPopulation: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
Outcome measures
| Measure |
Exemestane
n=39 Participants
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Gynecological AEs
|
0 participants
|
|
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Cardiac AEs
|
0 participants
|
|
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Venous thromboembolic events
|
0 participants
|
|
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Musculoskeletal AEs
|
0 participants
|
|
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Menopausal symptoms
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6, 12, 18, 24, 30, 36, 42Population: Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Month 6, 12, 18, 24, 30, 36, 42Population: Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.
Outcome measures
Outcome data not reported
Adverse Events
Exemestane
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exemestane
n=39 participants at risk
Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/39
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39
|
|
General disorders
Oedema
|
2.6%
1/39
|
|
General disorders
Oedema peripheral
|
2.6%
1/39
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.6%
1/39
|
|
Nervous system disorders
Convulsion
|
2.6%
1/39
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39
|
|
Nervous system disorders
Headache
|
5.1%
2/39
|
|
Nervous system disorders
Migraine
|
2.6%
1/39
|
|
Nervous system disorders
Paraesthesia
|
2.6%
1/39
|
|
Reproductive system and breast disorders
Breast pain
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
5.1%
2/39
|
|
Vascular disorders
Lymphoedema
|
2.6%
1/39
|
Additional Information
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