An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

Breast Neoplasms Clinical Trial

Official title:

An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00776659
• Other study ID #: A5991088
• Status: Terminated
• Phase: N/A
• First received: October 20, 2008
• Last updated: September 12, 2013
• Start date: December 2008
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Soumya Multi Specialty Hospital Ethics Committee
• Study type: Observational

Clinical Trial 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®

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Aromasin
Non-Interventional study design.

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	Ludhiana	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer	Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.	Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)	Yes
Primary	Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer		Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)	Yes
Primary	Number of Participants Who Died		Baseline until death (up to Year 3.5)	Yes
Primary	Number of Participants Who Discontinued Aromasin Therapy		Baseline until discontinuation (up to Year 3.5)	No
Primary	Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)	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.	Baseline up to 28 days after last dose of study treatment	Yes
Primary	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		Baseline, Month 6, 12, 18, 24, 30, 36, 42	Yes
Primary	Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42		Baseline, Month 6, 12, 18, 24, 30, 36, 42	Yes

External Links

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