Clinical trial NCT00776659: An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Official title: An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Neoplasms
Keywords: An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin
Antineoplastic Hormonal Drugs
Aromasin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Brief summary: To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.

* Efficacy of the treatment with Aromasin®
* Safety of the treatment with Aromasin®

Detailed description: NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria: Inclusion Criteria:

* Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Exclusion Criteria:

* Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included.
* Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.

Primary outcomes:
measure: Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
timeFrame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)
measure: Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
timeFrame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)
measure: Number of Participants Who Died
timeFrame: Baseline until death (up to Year 3.5)
measure: Number of Participants Who Discontinued Aromasin Therapy
timeFrame: Baseline until discontinuation (up to Year 3.5)
measure: Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
timeFrame: Baseline up to 28 days after last dose of study treatment
measure: Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42
timeFrame: Baseline, Month 6, 12, 18, 24, 30, 36, 42
measure: Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42
timeFrame: Baseline, Month 6, 12, 18, 24, 30, 36, 42
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: